Do Relaxation Exercises Decrease Postoperative Pain after Rotator Cuff Repair? A Randomized Controlled Trial

Objectives: During the last decade, concern about opioid dependence and abuse has spurred an increasing interest within orthopedic surgery to decrease reliance on narcotics for pain management. Non-pharmacologic interventions, such as patient opioid education, can decrease narcotic consumption after arthroscopic rotator cuff repair (ARCR). Another non-pharmacologic intervention, the use of relaxation exercises, has been promoted for pain management following surgical procedures; however, its’ effect has not been investigated following ARCR. The purpose of this investigation was to evaluate the effects of relaxation exercises on post-operative pain and narcotics use after ARCR. Methods: This was a prospective, randomized, controlled trial evaluating 151 consecutive patients undergoing ARCR. The treatment group (n: 75) received and reviewed relaxation education materials including a 5 minute video explaining relaxation breathing techniques, while the control group (n: 75) received no relaxation education materials. Both groups received a standardized pre-operative interscalene nerve block as well as the same standardized post-op care, including oxycodone 5mg/acetaminophen 325 mg, and cryotherapy. Patients recorded a 5-day journal of their pain level and opioid consumption. Patients were then queried with the American Shoulder and Elbow Surgeons (ASES) Shoulder Score, Single Assessment Numerical Evaluation (SANE) score, and Visual Analog Score (VAS) for pain pre-operatively, and at 2, 6, 12, 18, and 24 weeks post-operatively. Additionally, patients were given a follow-up survey at 2 weeks post-operative to assess subjective pain relief efficacy of the relaxation techniques. T-test analyses were utilized to compare differences between the treatment group and the control group. Results: Ninety-five percent of patients completed the follow-up survey. Sixty-three percent (43/68) of study group patients reported that the relaxation techniques decreased their pain levels, while 37% said that it had no effect on their pain. There were no significant differences between the study and control groups in mean post-op VAS pain scores on post-op day 1 (treatment: 55.40, control: 59.5; p= 0.94), post-op day 2 (treatment: 56.15, control: 56.93; p= 0.88), post-op day 3 (treatment: 48.38, control: 47.07; p= 0.52), post-op day 4 (treatment: 40.03, control: 45.54; p= 0.79) and post-op day 5 (treatment: 38.57, control: 40.57; p= 0.71). At two weeks post-op the study group consumed significantly less narcotics than the control group (mean: 21.7 doses vs. 29.7; p= 0.016, Cohen’s d: 0.42), and 51% were still performing the relaxation techniques. There were no significant differences in ASES and SANE scores at each time point throughout the study period. Conclusion: Although nearly two-thirds of patients in the treatment group believed that the use of relaxation breathing techniques decreased their pain, there was no difference in pain measures between the treatment group and the control group. However, the treatment group did utilize less opioid medication than the control group. While the effect on post-op pain is uncertain, the use of relaxation techniques can provide an easy to implement, non-pharmacologic strategy to significantly decrease narcotics consumption after ARCR.

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Psychodynamic therapy for adolescents suffering from co-morbid disorders of conduct and emotions in an in-patient setting: a randomized controlled trial

Psychological Medicine ◽

10.1017/s003329171300278x ◽

2013 ◽

Vol 44 (10) ◽

pp. 2213-2222 ◽

Cited By ~ 12

Author(s):

S. Salzer ◽

C. Cropp ◽

U. Jaeger ◽

O. Masuhr ◽

A. Streeck-Fischer

Keyword(s):

Randomized Controlled Trial ◽

Treatment Group ◽

Controlled Trial ◽

Academic Failure ◽

Psychodynamic Therapy ◽

Post Treatment ◽

Control Group ◽

Global Severity Index ◽

Randomized Controlled

BackgroundCo-morbid disorders of conduct and emotions can be regarded as childhood antecedents of further negative developments (e.g. manifestation of personality disorders in adulthood). We evaluated a manualized psychodynamic therapy (PDT) for adolescents with these co-morbid disorders.MethodIn a randomized controlled trial (RCT), 66 adolescents diagnosed with mixed disorders of conduct and emotions (F92 in ICD-10) were randomly assigned to a manualized in-patient PDT group or a waiting list/treatment-as-usual (WL/TAU) control condition. Diagnoses according to DSM-IV were also documented. Patients were compared using rates of remission as the primary outcome. The Global Severity Index (GSI) and the Strengths and Difficulties Questionnaire (SDQ) were used as secondary measures. Assessments were performed at baseline, post-treatment and at the 6-month follow-up.ResultsThe sample consisted of severely impaired adolescents with high rates of further co-morbid disorders and academic failure. Patients in the treatment group had a significantly higher rate of remission [odds ratio (OR) 26.41, 95% confidence interval (CI) 6.42–108.55, p < 0.001]. Compared with the control group, the PDT group resulted in significantly better outcomes on the SDQ (p = 0.04) but not the GSI (p = 0.18), with small between-group effect sizes (SDQ: d = 0.38, GSI: d = 0.18). However, the scores of patients treated with PDT were post-treatment no longer significantly different from normative data on the GSI and within the normal range on the SDQ. The effects in the treatment group were stable at follow-up. Furthermore, most patients were reintegrated into educational processes.ConclusionPDT led to remarkable improvement and furthered necessary preconditions for long-term stabilization. In future, PDT should be compared to other strong active treatments.

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Feasibility Study of a Randomized Controlled Trial Investigating Renal Denervation as a Possible Treatment Option in Patients With Loin Pain Hematuria Syndrome

Canadian Journal of Kidney Health and Disease ◽

10.1177/2054358120951390 ◽

2020 ◽

Vol 7 ◽

pp. 205435812095139

Author(s):

Bhanu Prasad ◽

Maryam Jafari ◽

Kaval Kour ◽

Kunal Goyal ◽

Francisco Garcia

Keyword(s):

Treatment Group ◽

Renal Denervation ◽

Controlled Trial ◽

Feasibility Trial ◽

Control Group ◽

Single Center ◽

Randomized Controlled ◽

Loin Pain

Background: Loin Pain Hematuria Syndrome (LPHS) is a poorly understood clinical condition characterized by severe pain localized to the kidney but in the absence of identifiable urinary tract disease. There is no consensus on optimal treatment strategies for LPHS. Case reports and series have shown renal denervation via catheter-based radiofrequency ablation to be an effective therapeutic option for the treatment of LPHS. To determine whether catheter-based renal denervation is a meaningful addition to the treatment options in these often-difficult-to-treat LPHS patients, a randomized clinical trial is needed. Prior to conducting a definitive trial that focuses on patient outcomes, ensuring the feasibility of undertaking such a trial is required. As such, we will conduct a single-center randomized control feasibility trial designed to determine viability and provide framework and direction for a larger trial. Objective: The objective of the study is to determine whether conducting a randomized trial of renal denervation versus sham procedure is feasible in terms of recruitment and eligibility, and adequacy of follow-up in LPHS patients. Design: Single-center double-blinded, parallel-group, partial crossover, sham-controlled, randomized feasibility trial of 10 LPHS patients. Setting: Regina General Hospital in Regina, Saskatchewan, Canada. Patients: Ten LPHS patients who require opioid therapy. Measurements: The main feasibility outcome measures include proportion of target patients who undergo the procedure (treatment or sham) within 6 months; proportion of randomized participants (treatment or control) who entirely complete the follow-up measures at 6 weeks, 3 and 6 months; proportion of the participants who were randomized to control group, cross over after 6 months and opt-in renal denervation treatment; proportion of the crossover participants who complete the follow-up measures at 6 weeks, 3 and 6 months. Pain will be assessed using Brief Pain Inventory Score, McGill Pain Questionnaire, and a pain diary. Mood, disability, and quality of life will be measured by Center for Epidemiologic Studies Depression Scale, Oswestry Disability Index, EuroQol-5D, and Short Form Health Survey Questionnaire, respectively. Methods: Eligible participants will be randomized into either renal denervation (treatment group) or a sham treatment (control group). Data (pain, quality of life, mood, disability) will be collected from both groups at baseline, 6 weeks, 3 and 6 months after the intervention. After the initial 6-month follow-up is over, the participants who received the sham procedure will cross over into the treatment group and will be followed for an additional 6 months in the same manner as the treatment group. Descriptive statistics will be used to report outcomes for all patients. Limitations: Single-center study, small sample size. Conclusions: The lessons learnt from this trial will lay the framework and direction for conducting a multisite randomized controlled trial involving a larger cohort of patients. Trial registration: ClinicalTrials.gov (NCT04332731).

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A Culturally Adapted Cognitive Behavioral Internet-Delivered Intervention for Depressive Symptoms: Randomized Controlled Trial (Preprint)

10.2196/preprints.13392 ◽

2019 ◽

Cited By ~ 1

Author(s):

Alicia Salamanca-Sanabria ◽

Derek Richards ◽

Ladislav Timulak ◽

Sarah Connell ◽

Monica Mojica Perilla ◽

...

Keyword(s):

College Students ◽

Randomized Controlled Trial ◽

Depressive Symptoms ◽

Treatment Group ◽

Controlled Trial ◽

Control Group ◽

Large Effect Size ◽

Randomized Controlled ◽

Culturally Adapted

BACKGROUND Internet-delivered treatments for depressive symptoms have proved to be successful in high-income Western countries. There may be potential for implementing such treatments in low- and middle-income countries such as Colombia, where access to mental health services is limited. OBJECTIVE The objective of this study was to assess the efficacy of a culturally adapted cognitive behavioral internet-delivered treatment for college students with depressive symptoms in Colombia. METHODS This was a randomized controlled trial with a 3-month follow-up. The program comprised seven modules. A total of 214 Colombian college students were recruited. They were assessed and randomly assigned to either the treatment group (n=107) or a waiting list (WL) control group (n=107). Participants received weekly support from a trained supporter. The primary outcome was symptoms of depression, as measured by the Patient Health Questionnaire - 9, and the secondary outcomes were anxiety symptoms assessed by the Generalized Anxiety Disorder questionnaire - 7. Other measures, including satisfaction with treatment, were evaluated after 7 weeks. RESULTS Research attrition and treatment dropouts were high in this study. On average, 7.6 sessions were completed per user. The mean time spent on the program was 3 hours and 18 min. The linear mixed model (LMM) showed significant effects after treatment (t 197.54=−5.189; P<.001) for the treatment group, and these effects were maintained at the 3-month follow-up (t 39.62=4.668; P<.001). Within-group results for the treatment group yielded a large effect size post treatment (d=1.44; P<.001), and this was maintained at the 3-month follow-up (d=1.81; P<.001). In addition, the LMM showed significant differences between the groups (t 197.54=−5.189; P<.001). The results showed a large effect size between the groups (d=0.91; P<.001). In the treatment group, 76.0% (16/107) achieved a reliable change, compared with 32.0% (17/107) in the WL control group. The difference between groups was statistically significant (X22=10.5; P=.001). CONCLUSIONS This study was the first contribution to investigating the potential impact of a culturally adapted internet-delivered treatment on depressive symptoms for college students as compared with a WL control group in South America. Future research should focus on identifying variables associated both with premature dropout and treatment withdrawal at follow-up. CLINICALTRIAL ClinicalTrials.gov NCT03062215; https://clinicaltrials.gov/ct2/show/NCT03062215

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Arthroscopic Rotator Cuff Repair With Graft Augmentation of 3-Dimensional Biological Collagen for Moderate to Large Tears: A Randomized Controlled Study

The American Journal of Sports Medicine ◽

10.1177/0363546518756978 ◽

2018 ◽

Vol 46 (6) ◽

pp. 1424-1431 ◽

Cited By ~ 12

Author(s):

You-Zhi Cai ◽

Chi Zhang ◽

Ri-Long Jin ◽

Tong Shen ◽

Peng-Cheng Gu ◽

...

Keyword(s):

Rotator Cuff ◽

Rotator Cuff Tears ◽

Controlled Study ◽

Control Group ◽

Study Group ◽

Randomized Controlled ◽

3D Collagen ◽

Cuff Repair ◽

Retear Rate

Background: Due to the highly organized tissue and avascular nature of the rotator cuff, rotator cuff tears have limited ability to heal after the tendon is reinserted directly on the greater tubercle of the humerus. Consequently, retears are among the most common complications after rotator cuff repair. Augmentation of rotator cuff repairs with patches has been an active area of research in recent years to reduce retear rate. Hypothesis: Graft augmentation with 3D collagen could prevent retears of the repaired tendon and improve tendon-bone healing in moderate to large rotator cuff tears. Study Design: Randomized controlled study; Level of evidence, 2. Methods: A prospective, randomized controlled study was performed in a consecutive series of 112 patients age 50 to 85 years who underwent rotator cuff repair with the suture-bridge technique (58 patients, control group) or the suture-bridge technique augmented with 3-dimensional (3D) collagen (54 patients, study group). All patients were followed for 28.2 months (range, 24-36 months). Visual analog scale score for pain, University of California Los Angeles (UCLA) shoulder score, and Constant score were determined. Magnetic resonance imaging was performed pre- and postoperatively (at a minimum of 24 months) to evaluate the integrity of the rotator cuff and the retear rate of the repaired tendon. Three patients in each group had biopsies at nearly 24 months after surgery with histological assessment and transmission electron microscopy. Results: A total of 104 patients completed the final follow-up. At the 12-month follow-up, the UCLA shoulder score was 28.1 ± 1.9 in the study group, which was significantly better than that in the control group (26.9 ± 2.1, P = .002). The Constant score was also significantly better in the study group (87.1 ± 3.2) than in the control group (84.9 ± 4.2, P = .003). However, at the final follow-up, no significant differences were found in the UCLA shoulder scores (29.4 ± 1.9 in the control group and 30.0 ± 1.6 in the study group, P = .052) or Constant scores (89.9 ± 3.2 in the control group and 90.8 ± 3.5 in the study group, P = .18). In terms of structural integrity, more patients in the study group had a favorable type I retear grade (18/51) than in the control group (10/53) ( P = .06). The postoperative retear rate was 34.0% in the control group and 13.7% in the study group, thus indicating a significantly lower retear rate in the study group ( P = .02). Biopsy specimens of the tendon-bone interface in 6 patients revealed more bone formation and more aligned fibers with larger diameters in the study group than in the control group. No intraoperative or postoperative complications were noted in either group. Conclusion: 3D collagen augmentation could provide effective treatment of moderate to large rotator cuff tears, providing substantial functional improvement, and could reduce the retear rate. This technique could also promote new tendon-bone formation, thus exerting a prominent effect on tendon-bone healing.

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Investigating the Effects of a Personalized, Spectrally Altered Music-Based Sound Therapy on Treating Tinnitus: A Blinded, Randomized Controlled Trial

Audiology and Neurotology ◽

10.1159/000450745 ◽

2016 ◽

Vol 21 (5) ◽

pp. 296-304 ◽

Cited By ~ 11

Author(s):

Shelly-Anne Li ◽

Lin Bao ◽

Michael Chrostowski

Keyword(s):

Randomized Controlled Trial ◽

Treatment Group ◽

Psychological Functioning ◽

Classical Music ◽

Controlled Trial ◽

Control Group ◽

Randomized Controlled ◽

Sound Therapy ◽

Tinnitus Distress

Objective: This blinded, randomized controlled trial assessed the effectiveness of a personalized, spectrally altered music-based sound therapy over 12 months of use. Method: Two groups of participants (n = 50) were randomized to receive either altered or unaltered classical music. The treatment group received classical music that had been modified based on spectral alterations specific to their tinnitus characteristics. Tinnitus and psychological functioning were assessed at baseline and 3, 6, and 12 months after initial testing using self-reports. Participants, investigators and research assistants were blinded from group assignment. Results: Data from 34 participants were analyzed. The treatment group reported significantly lower levels of tinnitus distress (primary outcome, assessed using the Tinnitus Handicap Inventory) than the control group throughout the follow-up period. Among the treatment group, there were statistically significant and clinically meaningful levels of reduction in tinnitus distress, severity, and functional impairment at 3- and 6-month follow-ups, which was sustained at the 12-month follow-up. Conclusion: The personalized music therapy was effective in reducing subjective tinnitus and represents a meaningful advancement in tinnitus intervention.

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Randomized Controlled Trial: Cognitive-Narrative Therapy for IPV Victims

Journal of Interpersonal Violence ◽

10.1177/0886260520943719 ◽

2020 ◽

pp. 088626052094371

Author(s):

André Moreira ◽

Ana Cristina Moreira ◽

José Carlos Rocha

Keyword(s):

Randomized Controlled Trial ◽

Treatment Group ◽

Narrative Therapy ◽

Stress Disorder ◽

Controlled Trial ◽

Assessment Instrument ◽

Control Group ◽

Randomized Controlled ◽

Treatment Of Depression

The objective is to test the efficacy of cognitive-narrative therapy in the treatment of depression, post-traumatic stress disorder (PTSD), complex posttraumatic stress disorder (CPTSD) and borderline symptoms on a sample of women who suffered from intimate partner violence (IPV). Trial design is a longitudinal randomized controlled trial with a sample of 19 battered women allocated in two groups, a control group and treatment group, assessed twice at baseline before intervention, and at follow-up. The outcome measures were the Patient Health Questionnaire, International Trauma Questionnaire, PTSD and CPTSD Diagnostic Interview Schedule for International Classification of Diseases (ICD)-11, Conjugal Violence Exposure Scale (CVES), Life Events Checklist and Intervention Program Satisfaction Assessment Instrument. The treatment group received a four-session cognitive-narrative manualized intervention. There were no statistically significant differences between groups at baseline and follow-up, however, positive effect sizes ranging between 0.04 and 0.43 were found in depression, PTSD, and borderline, as well in some CPTSD dimensions when analyzing baseline-follow-up deltas between groups. There was also a negative effect size of –0.28 in the CPTSD total. This intervention is effective in the treatment of depression, PTSD and borderline and is an important tool in the treatment of these disorders.

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Effectiveness and safety of a mixture of diosmin, coumarin and arbutin (Linfadren®) in addition to conventional treatment in the management of patients with post-trauma/surgery persistent hand edema: a randomized controlled trial

Clinical Rehabilitation ◽

10.1177/0269215519829797 ◽

2019 ◽

Vol 33 (5) ◽

pp. 904-912 ◽

Cited By ~ 1

Author(s):

Angelo Cacchio ◽

Giancarlo Di Carlo ◽

Cofini Vincenza ◽

De Blasis Elisabetta

Keyword(s):

Randomized Controlled Trial ◽

Conventional Treatment ◽

Rescue Medication ◽

Controlled Trial ◽

Trauma Surgery ◽

Control Group ◽

Study Group ◽

Randomized Controlled ◽

End Of Treatment

Objective: To evaluate the effectiveness and safety of oral administration of Linfadren® in addition to conventional treatment in patients with post-trauma/surgery persistent hand edema. Design: Parallel-group randomized controlled trial. Setting: Outpatient rehabilitation center. Subjects: A total of 60 outpatients (mean age 48.5 (standard deviation (SD) = 12.3) years) with post-trauma/surgery persistent hand edema. Interventions: Patients were randomized to either receive six-week conventional treatment plus Linfadren® (Study Group) or conventional treatment (Control Group). Main Measures: Primary outcome was hand edema as measured by figure-of-eight method. Secondary outcomes were hand function, patient’s overall perceived treatment effectiveness and rescue medication request. Tolerability of Linfadren® was also evaluated. Assessments were performed at baseline, at the end of treatment and three months after the end of treatment. Results: All patients completed the six-week program and 57 patients (95%) completed the three-month follow-up. At six weeks, the Study Group had significantly greater improvement in hand edema (423.3 (SD = 23.8) mm vs 439.4 (SD = 22.6) mm; P = 0.009) and upper limb function ( Quick Disabilities of Arm, Shoulder and Hand questionnaire: 23.6 (SD = 13.6) vs 37.7 (SD = 15.9); P = 0.005) compared to the Control Group. Moreover, the percentage of patients who perceived treatment as effective was significantly higher in the Study Group than in the Control Group both after treatment (70% vs 37%, P = 0.002) and at follow-up (77% vs 30%, P < 0.0001). The rescue medication request was not different between groups. No adverse events were recorded. Conclusion: Linfadren® in addition to conventional treatment was safe and more effective than conventional treatment alone in patients with post-trauma/surgery persistent hand edema.

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Is It Necessary to Repair Stable Ramp Lesions of the Medial Meniscus During Anterior Cruciate Ligament Reconstruction? A Prospective Randomized Controlled Trial

The American Journal of Sports Medicine ◽

10.1177/0363546516682493 ◽

2017 ◽

Vol 45 (5) ◽

pp. 1004-1011 ◽

Cited By ~ 40

Author(s):

Xin Liu ◽

Hui Zhang ◽

Hua Feng ◽

Lei Hong ◽

Xue-song Wang ◽

...

Keyword(s):

Randomized Controlled Trial ◽

Clinical Outcomes ◽

Acl Reconstruction ◽

Medial Meniscus ◽

Controlled Trial ◽

Control Group ◽

Study Group ◽

Randomized Controlled ◽

Kt 1000

Background: A special type of meniscal lesion involving the peripheral attachment of the posterior horn of the medial meniscus (PHMM), termed a “ramp lesion,” is commonly associated with an anterior cruciate ligament (ACL) injury. However, its treatment is still controversial. Recently, stable ramp lesions treated with abrasion and trephination alone have been shown to have good clinical outcomes after ACL reconstruction. Hypothesis: Stable ramp lesions treated with abrasion and trephination alone during ACL reconstruction will result in similar clinical outcomes compared with those treated with surgical repair. Study Design: Randomized controlled trial; Level of evidence, 2. Methods: A prospective randomized controlled study was performed in 91 consecutive patients who had complete ACL injuries and concomitant stable ramp lesions of the medial meniscus. All patients were randomly allocated to 1 of 2 groups based on whether the stable ramp lesions were surgically repaired (study group; n = 50) or only abraded and trephined (control group; n = 41) during ACL reconstruction. All surgical procedures were performed by a single surgeon who was blinded to the functional assessment findings of the patients. The Lysholm score, subjective International Knee Documentation Committee (IKDC) score, and stability assessments (pivot-shift test, Lachman test, KT-1000 arthrometer side-to-side difference, and KT-1000 arthrometer differences of <3, 3-5, and >5 mm) were evaluated preoperatively and at the last follow-up. Moreover, magnetic resonance imaging (MRI) was used to evaluate the healing status of the ramp lesions. Results: All consecutive patients who were screened for eligibility from August 2008 to April 2012 were enrolled and observed clinically. There were 40 patients in the study group and 33 patients in the control group who were observed for at least 2 years. At the final follow-up, there were no significant differences between the study group and the control group in terms of the mean Lysholm score (88.7 ± 4.8 vs 90.4 ± 5.8, respectively; P = .528), mean subjective IKDC score (83.6 ± 3.7 vs 82.2 ± 4.5, respectively; P = .594), pivot-shift test results ( P = .658), Lachman test results ( P = .525), KT-1000 arthrometer side-to-side difference (1.6 ± 1.2 vs 1.5 ± 1.1, respectively; P = .853), or KT-1000 arthrometer grading ( P = .738). Overall, for both groups (n = 73), 67 patients showed completely healed (38 study, 29 control), 3 showed partially healed (1 study, 2 control), and 3 showed nonhealed (1 study, 2 control) signals on follow-up MRI when evaluating the healing status of the ramp lesions. There was no significant difference regarding the healing status of the ramp lesions between the 2 groups ( P = .543). Conclusion: This prospective randomized controlled trial showed that, in terms of subjective scores, knee stability, and meniscal healing status, concomitant stable ramp lesions of the medial meniscus treated with abrasion and trephination alone during ACL reconstruction resulted in similar clinical outcomes compared with those treated with surgical repair.

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A Culturally Adapted Cognitive Behavioral Internet-Delivered Intervention for Depressive Symptoms: Randomized Controlled Trial

JMIR Mental Health ◽

10.2196/13392 ◽

2020 ◽

Vol 7 (1) ◽

pp. e13392 ◽

Cited By ~ 4

Author(s):

Alicia Salamanca-Sanabria ◽

Derek Richards ◽

Ladislav Timulak ◽

Sarah Connell ◽

Monica Mojica Perilla ◽

...

Keyword(s):

College Students ◽

Randomized Controlled Trial ◽

Depressive Symptoms ◽

Treatment Group ◽

Controlled Trial ◽

Control Group ◽

Large Effect Size ◽

Randomized Controlled ◽

Culturally Adapted

Background Internet-delivered treatments for depressive symptoms have proved to be successful in high-income Western countries. There may be potential for implementing such treatments in low- and middle-income countries such as Colombia, where access to mental health services is limited. Objective The objective of this study was to assess the efficacy of a culturally adapted cognitive behavioral internet-delivered treatment for college students with depressive symptoms in Colombia. Methods This was a randomized controlled trial with a 3-month follow-up. The program comprised seven modules. A total of 214 Colombian college students were recruited. They were assessed and randomly assigned to either the treatment group (n=107) or a waiting list (WL) control group (n=107). Participants received weekly support from a trained supporter. The primary outcome was symptoms of depression, as measured by the Patient Health Questionnaire - 9, and the secondary outcomes were anxiety symptoms assessed by the Generalized Anxiety Disorder questionnaire - 7. Other measures, including satisfaction with treatment, were evaluated after 7 weeks. Results Research attrition and treatment dropouts were high in this study. On average, 7.6 sessions were completed per user. The mean time spent on the program was 3 hours and 18 min. The linear mixed model (LMM) showed significant effects after treatment (t197.54=−5.189; P<.001) for the treatment group, and these effects were maintained at the 3-month follow-up (t39.62=4.668; P<.001). Within-group results for the treatment group yielded a large effect size post treatment (d=1.44; P<.001), and this was maintained at the 3-month follow-up (d=1.81; P<.001). In addition, the LMM showed significant differences between the groups (t197.54=−5.189; P<.001). The results showed a large effect size between the groups (d=0.91; P<.001). In the treatment group, 76.0% (16/107) achieved a reliable change, compared with 32.0% (17/107) in the WL control group. The difference between groups was statistically significant (X22=10.5; P=.001). Conclusions This study was the first contribution to investigating the potential impact of a culturally adapted internet-delivered treatment on depressive symptoms for college students as compared with a WL control group in South America. Future research should focus on identifying variables associated both with premature dropout and treatment withdrawal at follow-up. Trial Registration ClinicalTrials.gov NCT03062215; https://clinicaltrials.gov/ct2/show/NCT03062215

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Effects of Aerobic, Resistance, or Combined Exercise Training Among Older Adults with Subjective Memory Complaints: A Randomized Controlled Trial

Journal of Alzheimer s Disease ◽

10.3233/jad-210047 ◽

2021 ◽

pp. 1-17

Author(s):

Taeko Makino ◽

Hiroyuki Umegaki ◽

Masahiko Ando ◽

Xian Wu Cheng ◽

Koji Ishida ◽

...

Keyword(s):

Older Adults ◽

Exercise Training ◽

Controlled Trial ◽

Community Dwelling ◽

Control Group ◽

Subjective Memory ◽

Logical Memory ◽

Randomized Controlled ◽

Community Dwelling Older Adults

Background: Physical exercise is suggested to be effective for preventing cognitive decline in older adults, but the relative efficacy of different types of exercise have yet to be clarified. Objective: This single-blinded randomized controlled trial was designed to investigate the differential effects of aerobic exercise training (AT), resistance exercise training (RT), and combined exercise training (CT) on cognition in older adults with subjective memory complaints (SMC). Methods: Community-dwelling older adults with SMC (n = 415; mean age = 72.3 years old) were randomly assigned to one of the four groups: AT, RT, CT, or control group. The study consisted of two phases: a 26-week intervention and a 26-week follow-up. The participants were evaluated at baseline, 26 weeks (postintervention), and 52 weeks (follow-up). The primary outcome of this study was memory function, which was assessed using the Logical Memory II subtest of the Wechsler Memory Scale-Revised (WMS-R) score. The secondary outcomes included global cognitive function, verbal fluency, working memory, processing speed, and executive functions. Results: Intention-to-treat analysis by a mixed-effect model repeated measure showed that the AT group had significantly improved performance on the WMS-R Logical Memory II test (2.74 [1.82–3.66] points) than the control group (1.36 [0.44–2.28] points) at the postintervention assessment (p = 0.037). The effect was more pronounced in those without amnesia than those with amnesia. No significant improvement was observed in the RT and CT groups. Conclusion: This study suggests that AT intervention can improve delayed memory in community-dwelling older adults, particularly in individuals without objective memory decline.

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