scholarly journals Feasibility of an 8-week Yoga Intervention among Middle-aged and Older Adults

2020 ◽  
Vol 4 (4) ◽  
Author(s):  
Neha P. Gothe ◽  
Emily Erlenbach ◽  
Keyword(s):  
Older Adults ◽  
Adverse Events ◽  
Controlled Trial ◽  
Critical Role ◽  
Feasibility Studies ◽  
Target Population ◽  
Control Group ◽  
Middle Aged ◽  
Yoga Intervention ◽  
Enrollment Rates

Feasibility studies play a critical role in determining whether the target population is likely to engage with larger scale efficacy and effectiveness trials. Feasibility data for yoga interventions designed and conducted with older adults is limited. In this paper we present feasibility and acceptability data from an 8-week randomized controlled trial (RCT) conducted with middle aged and older adults. Participants n=118 (Mean age: 62.0 years) were randomized to either a Hatha yoga or Stretching Control group with hour long group exercise classes held 3x/week for 8 weeks. Herein we report feasibility and acceptability, including enrollment rates, attendance, attrition and adverse events, participant feedback and satisfaction data. Of the 265 adults screened, 118 were eligible and randomized. Session attendance was high for both groups (80.82 to 81.29 %) and only 10 people were lost to follow-up. Program satisfaction for both groups was high (4.8 and 4.86 out of 5) and no adverse events were reported. Participants’ feedback regarding most and least helpful aspects of the program as well as suggestions for future yoga interventions are summarized. Overall, the yoga intervention was highly feasible and acceptable. The feasibility parameters from this trial can aid researchers in estimating desired sample sizes to successfully recruit, randomize and retain older adults in short- and long-term yoga based RCTs.

scholarly journals Animal-Assisted Therapy in Middle-Aged and Older Patients With Schizophrenia: A Randomized Controlled Trial

2021 ◽  
Vol 12 ◽  
Author(s):  
Tzu-Ting Chen ◽  
Ton-Lin Hsieh ◽  
Mei-Li Chen ◽  
Wei-Ting Tseng ◽  
Chi-Fa Hung ◽  
...  
Keyword(s):  
Older Adults ◽  
Randomized Controlled Trial ◽  
Older Patients ◽  
Controlled Trial ◽  
Chronic Schizophrenia ◽  
Animal Assisted Therapy ◽  
Control Group ◽  
Middle Aged ◽  
Randomized Controlled ◽  
Usual Treatment

Objective: Animal-assisted therapy (AAT) has the potential to improve the symptomology, negative emotions, and level of well-being in older adults, as well as patients with mental illness. However, there remains limited evidence supporting the treatment efficacy of AAT in middle-aged and older adults with schizophrenia. Therefore, this study implemented a randomized controlled trial to assess the efficacy of a 12-week AAT psychological intervention with dogs for middle-aged and older patients with chronic schizophrenia in a clinical setting.Method: Patients, age ≥ 40 years, with chronic schizophrenia were allocated randomly to either the AAT group or control group. Patients in the AAT group received an additional hour -long AAT session every week for 12 weeks. Patients in the control group received the usual treatment plus an hour long non-animal related intervention. All patients were assessed based on primary outcome measures before and after the 12-week intervention, including the Positive and Negative Syndrome Scale (PANSS), Depression Anxiety Stress Scales Assessment (DASS), and Chinese Happiness Inventory (CHI).Results: Patients who received AAT had greater improvements in the PANSS and DASS-stress subscale scores than the control group (p < 0.05). The effect was small (success ratio different, SRD = 0.25) for the PANSS and the DASS-stress subscale (SRD = 0.15). There were no significant differences in the change scores of the CHI between the AAT and control groups (p = 0.461).Conclusions: AAT seemed to be effective in reducing psychiatric symptoms and stress levels of middle-aged and older patients with schizophrenia. AAT could be considered as a useful adjunctive therapy to the usual treatment programs.

The Effect of Lavender Oil on Perioperative Pain, Anxiety, Depression, and Sleep after Microvascular Breast Reconstruction: A Prospective, Single-Blinded, Randomized, Controlled Trial

2021 ◽  
Author(s):  
Ronnie L. Shammas ◽  
Caitlin E. Marks ◽  
Gloria Broadwater ◽  
Elliot Le ◽  
Adam D. Glener ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Adverse Events ◽  
Breast Reconstruction ◽  
Controlled Trial ◽  
Depression Scale ◽  
Control Group ◽  
Lavender Oil ◽  
Entire Cohort ◽  
Randomized Controlled ◽  
Anxiety Depression

Abstract Background Psychosocial distress, depression, or anxiety can occur in up to 50% of women after a breast cancer diagnosis and mastectomy. The purpose of this study was to assess the potential benefit of lavender oil as a perioperative adjunct to improve anxiety, depression, pain, and sleep in women undergoing microvascular breast reconstruction. Methods This was a prospective, single-blinded, randomized, controlled trial of 49 patients undergoing microvascular breast reconstruction. Patients were randomized to receive lavender oil or placebo (coconut oil) throughout their hospitalization. The effect of lavender oil on perioperative stress, anxiety, depression, sleep, and pain was measured using the hospital anxiety and depression scale, Richards–Campbell Sleep Questionnaire, and the visual analogue scale. Results Twenty-seven patients were assigned to the lavender group and 22 patients were assigned to the control group. No significant differences were seen in the perioperative setting between the groups with regard to anxiety (p = 0.82), depression (p = 0.21), sleep (p = 0.86), or pain (p = 0.30) scores. No adverse events (i.e., allergic reaction) were captured, and no significant differences in surgery-related complications were observed. When evaluating the entire cohort, postoperative anxiety scores were significantly lower than preoperative scores (p < 0.001), while depression scores were significantly higher postoperatively as compared with preoperatively (p = 0.005). Conclusion In the setting of microvascular breast reconstruction, lavender oil and aromatherapy had no significant adverse events or complications; however, there were no measurable advantages pertaining to metrics of depression, anxiety, sleep, or pain as compared with the control group.

Water exchange-assisted vs. carbon dioxide-insufflated single-balloon enteroscopy: randomized controlled trial

Endoscopy ◽  
2021 ◽  
Author(s):  
Shaopeng Liu ◽  
Tao Dong ◽  
Yupeng Shi ◽  
Hui Luo ◽  
Xianmin Xue ◽  
...  
Keyword(s):  
Carbon Dioxide ◽  
Randomized Controlled Trial ◽  
Adverse Events ◽  
Water Exchange ◽  
Controlled Trial ◽  
Control Group ◽  
Balloon Enteroscopy ◽  
Randomized Controlled ◽  
Single Balloon ◽  
Single Balloon Enteroscopy

<b>Background and study aims</b> Single-balloon enteroscopy (SBE) is a valuable but difficult modality for the diagnosis and treatment of small-bowel diseases. The water exchange (WE) method has the advantage of facilitating intubation during colonoscopy. Here, we evaluated the effects of WE on procedure-related variables related to SBE. <b>Patients and methods</b> This randomized controlled trial was conducted in a tertiary-care referral center in China. Patients with attempt at total enteroscopy (ATE) were randomly allocated to undergo WE-assisted (WE group) or carbon dioxide-insufflated enteroscopy (CO<sub>2</sub> group). All patients were planned to undergo both antegrade and retrograde procedures. The primary outcome was the total enteroscopy rate (TER). Secondary outcomes included maximal insertion depth, positive findings, procedural time and adverse events. <b>Results</b> In total, 110 patients were enrolled, with 55 in each group. Baseline characteristics between the two groups were comparable. TER was achieved in 58.2% (32/55) of the WE group and 36.4% (20/55) of the control group (p=0.022). The estimated intubation depth was 521.2±101.4 cm in the WE group and 481.6±95.2 cm in the CO<sub>2</sub> group (p=0.037). The insertion time was prolonged in the WE group compared with CO<sub>2</sub> group (178.9±45.1 min vs. 154.2±27.6 min, p<0.001). Endoscopic findings and adverse events were comparable between the two groups. <b>Conclusions</b> The WE method improved TER and increased intubation depth during SBE. The use of WE did not increase complications of enteroscopy. Clinical trial registation: https://clinicaltrials.gov/， NCT01942863.

scholarly journals Toe Clearance Rehabilitative Slippers for Older Adults With Fall Risk: A Randomized Controlled Trial

2021 ◽  
Vol 12 ◽  
pp. 215145932110291
Author(s):  
Atsuko Satoh ◽  
Yukoh Kudoh ◽  
Sangun Lee ◽  
Masumi Saitoh ◽  
Miwa Miura ◽  
...  
Keyword(s):  
Older Adults ◽  
Fall Risk ◽  
Controlled Trial ◽  
Intervention Group ◽  
Berg Balance Scale ◽  
Control Group ◽  
Mobility Assessment ◽  
Before And After ◽  
Day Services ◽  
And Control

Introduction: To evaluate fall-prevention rehabilitative slippers for use by self-caring, independent older adults. Materials and Methods: This assessor-blinded, randomized, and controlled 1-year study included 59 self-caring, independent participants (49 women) who attended day services. The mean age of participants was 84.0 ± 5.3 years. Participants were randomly selected from 8 nursing homes. We tested slippers top-weighted with a lead bead (200, 300, or 400 g). Intervention group participants walked while wearing the slippers for 10-20 min, 1-3 days/week at the day service center. Fall risk was measured using the Berg Balance Scale and the Tinetti Performance-Oriented Mobility Assessment (POMA) before and at 3-month intervals after the intervention/control phase. Results: After 12 months, the intervention group demonstrated significant improvement. Berg Balance and POMA compared to the control group ( p < .05 p < .01, respectively). Mobility scores improved significantly for both measurements in the intervention group before and after ( p < .01), but the control group had significantly lower scores. Discussion: Overall, falls decreased in the intervention group from 10 to 7, and control group falls increased from 9 to 16 ( p = .02). No adverse events related to the intervention were reported. Conclusions: Rehabilitation training slippers may reduce falls in older adults.

scholarly journals Effect of isometric exercises on the masseter muscle in older adults with missing dentition: a randomized controlled trial

2021 ◽  
Vol 11 (1) ◽  
Author(s):  
Satoru Takano ◽  
Kohei Yamaguchi ◽  
Kazuharu Nakagawa ◽  
Kanako Yoshimi ◽  
Ayako Nakane ◽  
...  
Keyword(s):  
Older Adults ◽  
Masseter Muscle ◽  
Controlled Trial ◽  
Intervention Group ◽  
Muscle Thickness ◽  
Control Group ◽  
Older Individuals ◽  
Muscle Properties ◽  
Oral Function ◽  
Masticatory Ability

AbstractMaintaining oral function in older individuals with missing teeth is important for leading a healthy and independent life. This study aimed to evaluate whether simple isometric exercises can maintain and improve the oral function [maximum occlusal force (MOF) and masticatory ability (MA)] and the masticatory muscle properties [masseter muscle thickness (MMT) and echo intensity (MMEI)] in older adults during the maintenance phase of removable prosthetic treatment. Participants were randomly categorized into the intervention and control groups. The mouthpieces were distributed, and participants were instructed to use them for exercising. The intervention group was instructed to perform maximum clenching for 10 s, whereas the control group was instructed to tap the teeth at an arbitrary speed for 10 s. Both were repeated five times at an interval of 5 s between each activity and twice daily for 4 weeks. The outcomes were measured after a month of exercise. The intervention group showed a significant improvement in the MOF, MMT during contraction, MMT at rest and MMEI during contraction. There were no significant differences in the MA and MMEI at rest. In the control group, no improvement was observed in any of the parameters. When the isometric exercises were performed using a mouthpiece, there was an improvement in the oral function and masseter muscle properties in older individuals with Eichner B status who used dentures.

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

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.

Pulsed Ultrasounds Reduce Pain and Disability, Increasing Rib Fracture Healing, in a Randomized Controlled Trial

Pain Medicine ◽  
2018 ◽  
Vol 20 (10) ◽  
pp. 1980-1988
Author(s):  
Norberto Santana-Rodríguez ◽  
Bernardino Clavo ◽  
Pedro Llontop ◽  
María D Fiuza ◽  
Joaquín Calatayud-Gastardi ◽  
...  
Keyword(s):  
Physical Activity ◽  
Randomized Controlled Trial ◽  
Adverse Events ◽  
Controlled Trial ◽  
Pain Medication ◽  
Control Group ◽  
Work Activity ◽  
Randomized Controlled ◽  
Medication Intake ◽  
Bone Callus

AbstractIntroductionRib fractures are an important health issue worldwide, with significant, pain, morbidity, and disability for which only symptomatic treatment exists.ObjectivesBased on our previous experimental model, the objective of the current study was to assess for the first time whether pulsed ultrasound (PUS) application could have beneficial effects on humans.MethodsProspective, double-blinded, randomized, controlled trial of 51 patients. Four were excluded, and 47 were randomized into the control group (N = 23) or PUS group (N = 24). The control group received a PUS procedure without emission, and the PUS group received 1 Mhz, 0.5 W/cm2 for 1 min/cm2. Pain level, bone callus healing rate, physical and work activity, pain medication intake, and adverse events were blindly evaluated at baseline and one, three, and six months.ResultsThere were no significant differences at baseline between groups. PUS treatment significantly decreased pain by month 1 (P = 0.004), month 3 (P = 0.005), and month 6 (P = 0.025), significantly accelerated callus healing by month 1 (P = 0.013) and month 3 (P < 0.001), accelerated return to physical activity by month 3 (P = 0.036) and work activity (P = 0.001) by month 1, and considerably reduced pain medication intake by month 1 (P = 0.057) and month 3 (P = 0.017). No related adverse events were found in the PUS group.ConclusionsThis study is the first evidence that PUS treatment is capable of improving rib fracture outcome, significantly accelerating bone callus healing, and decreasing pain, time off due to both physical activity and convalescence period, and pain medication intake. It is a safe, efficient, and low-cost therapy that may become a new treatment for patients with stable rib fractures.

scholarly journals Team approach to polypharmacy evaluation and reduction: study protocol for a randomized controlled trial

Trials ◽  
2021 ◽  
Vol 22 (1) ◽  
Author(s):  
Dee Mangin ◽  
Larkin Lamarche ◽  
Gina Agarwal ◽  
Hoan Linh Banh ◽  
Naomi Dore Brown ◽  
...  
Keyword(s):  
Older Adults ◽  
Primary Care ◽  
Randomized Controlled Trial ◽  
Clinical Pathway ◽  
Controlled Trial ◽  
Primary Objective ◽  
Control Group ◽  
Team Approach ◽  
Potentially Inappropriate Medications ◽  
Randomized Controlled

Abstract Background Polypharmacy in older adults can be associated with negative outcomes including falls, impaired cognition, reduced quality of life, and general and functional decline. It is not clear to what extent these are reversible if the number of medications is reduced. Primary care does not have a systematic approach for reducing inappropriate polypharmacy, and there are few, if any, approaches that account for the patient’s priorities and preferences. The primary objective of this study is to test the effect of TAPER (Team Approach to Polypharmacy Evaluation and Reduction), a structured operationalized clinical pathway focused on reducing inappropriate polypharmacy. TAPER integrates evidence tools for identifying potentially inappropriate medications, tapering, and monitoring guidance and explicit elicitation of patient priorities and preferences. We aim to determine the effect of TAPER on the number of medications (primary outcome) and health-related outcomes associated with polypharmacy in older adults. Methods We designed a multi-center randomized controlled trial, with the lead implementation site in Hamilton, Ontario. Older adults aged 70 years or older who are on five or more medications will be eligible to participate. A total of 360 participants will be recruited. Participants will be assigned to either the control or intervention arm. The intervention involves a comprehensive multidisciplinary medication review by pharmacists and physicians in partnership with patients. This review will be focused on reducing medication burden, with the assumption that this will reduce the risks and harms of polypharmacy. The control group is a wait list, and control patients will be given appointments for the TAPER intervention at a date after the final outcome assessment. All patients will be followed up and outcomes measured in both groups at baseline and 6 months. Discussion Our trial is unique in its design in that it aims to introduce an operationalized structured clinical pathway aimed to reduce polypharmacy in a primary care setting while at the same time recording patient’s goals and priorities for treatment. Trial registration Clinical Trials.gov NCT02942927. First registered on October 24, 2016.

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