Effects of exercise on fitness and cognition in progressive MS: a randomized, controlled pilot trial

Background: Exercise may have beneficial effects on both well-being and walking ability in multiple sclerosis (MS). Exercise is shown to be neuroprotective in rodents and may also enhance cognitive function in humans. It may, therefore, be particularly useful for MS patients with pronounced neurodegeneration. Objective: To investigate the potential of standardized exercise as a therapeutic intervention for progressive MS, in a randomized-controlled pilot trial. Methods: Patients with progressive MS and moderate disability (Expanded Disability Status Scale (EDSS) of 4–6) were randomized to one of three exercise interventions (arm ergometry, rowing, bicycle ergometry) for 8–10 weeks or a waitlist control group. We analyzed the drop-out rate as a measure of feasibility. The primary endpoint of the study was aerobic fitness. Secondary endpoints were walking ability, cognitive function as measured by a neuropsychological test battery, depression and fatigue. Results: A total of 42 patients completed the trial (10.6% drop-out rate). Significant improvements were seen in aerobic fitness. In addition, exercise improved walking ability, depressive symptoms, fatigue and several domains of cognitive function. Conclusion: This study indicated that aerobic training is feasible and could be beneficial for patients with progressive MS. Larger exercise studies are needed to confirm the effect on cognition. Trial Registration: ISRCTN (trial number 76467492) http://isrctn.org

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PREVALENCE AND PATTERN OF UTERINE BLEEDING AMONG BREASTFEEDING WOMEN USING PROGESTERONE-ONLY PILLS

Public Health of Indonesia ◽

10.36685/phi.v4i3.203 ◽

2018 ◽

Vol 4 (3) ◽

pp. 100-107

Author(s):

Prima Dhewi Ratrikaningtyas ◽

Dian Rosdiana ◽

Siswanto Agus Wilopo

Keyword(s):

Randomized Controlled Trial ◽

Controlled Trial ◽

Uterine Bleeding ◽

Drop Out ◽

Control Group ◽

Double Blind ◽

Randomized Controlled ◽

Drop Out Rate ◽

Contraceptive Pills ◽

National Family Planning

Background: Progesterone-Only Pill (POPs) is one of the ideal oral contraceptive methods for breastfeeding women. Discontinuation of POPs was mostly due to bleeding pattern disorders.Objective: The purpose of this study is to identify the prevalence and pattern of uterine bleeding on breastfeeding women using contraceptive pills containing progesterone derivatives.Methods: This study is a double blind block randomized controlled trial for the treatment group (levonorgestrel or lynestrenol pills) and non-randomized controlled trial for the control group, 6-8 weeks’ postpartum women, 20 to 35-year-old, and breastfeeding. Monthly follow up was done for 6 months. Analysis was done using survival analysis, X2,and Cox’s Proportional Hazard.Results: A hundred and seven women were involved with a drop-out rate of 17.8%. Subjects characteristics were ≤ 32-year-old, multiparous, ever used contraception with birth spacing of 60 months. Spotting and amenorrhea was the most common pattern. Levonorgestrel causes bleeding/menstrual resumption sooner in breastfeeding women than Lynestrenol.Conclusion: The most common uterine bleeding on women using Progesterone-only Pills were spotting and amenorrhea. By recognizing such effects, for Indonesian women, POPs was expected to be produced in the country and can be included in the national family planning programs.

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Inquiry Based Stress Reduction (IBSR) Improves Overall Stuttering Experience among Adults Who Stutter: A Randomized Controlled Trial

Journal of Clinical Medicine ◽

10.3390/jcm10102187 ◽

2021 ◽

Vol 10 (10) ◽

pp. 2187

Author(s):

Omrit Feldman ◽

Eran Goldstien ◽

Benjamin Rolnik ◽

Ariel B. Ganz ◽

Shahar Lev-Ari

Keyword(s):

Quality Of Life ◽

Stress Reduction ◽

Satisfaction With Life ◽

Psychological Flexibility ◽

Well Being ◽

The United States ◽

Control Group ◽

Randomized Controlled ◽

Adults Who Stutter

Stuttering is a speech disorder that can cause disturbances in the timing and flow of speech. In addition to being a communication disorder, stuttering is often accompanied by a reduction in the quality of life and has impacts on social status, mental well-being, self-acceptance, and the chances of integration into the labor market. The Inquiry Based Stress Reduction (IBSR) program, developed in the United States by Byron Katie in 1986, is the clinical application of “The Work” method (Thework.com) and represents an emerging mindfulness and cognitive-reframing method. IBSR has been demonstrated to improve mental health and well-being in adults and may alleviate psychological and psychosocial symptoms of stuttering. The purpose of this trial was to examine the effect of a 12-week IBSR intervention on the overall stuttering experience and indicators of anxiety, psychological flexibility, and well-being among adults who stutter (AWS). This study was a randomized controlled clinical trial. Participants were randomized to IBSR (n = 28) and control (n = 28) groups. Validated questionnaires of overall stuttering experience (OASES-A), anxiety (STAI), psychological flexibility (PFQ), and satisfaction with life (SWLS) were completed before, after, and one month after the intervention. An intention-to-treat approach was implemented for analysis. Our results show that participants in the IBSR intervention group exhibited a greater improvement in their overall stuttering experience as compared to the control group, as well as in general information on stuttering awareness and perception, reactions to stuttering, communication in daily situations, and quality of life. In addition, we found a greater reduction in anxiety levels and an increase in satisfaction-with-life scores in the IBSR group. These results indicate that IBSR can improve the overall stuttering experience.

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Foam Rolling Elicits Neuronal Relaxation Patterns Distinct from Manual Massage: A Randomized Controlled Trial

Brain Sciences ◽

10.3390/brainsci11060818 ◽

2021 ◽

Vol 11 (6) ◽

pp. 818

Author(s):

Yann Kerautret ◽

Aymeric Guillot ◽

Sébastien Daligault ◽

Franck Di Rienzo

Keyword(s):

Skin Conductance ◽

Muscle Pain ◽

Controlled Trial ◽

Muscle Relaxation ◽

Well Being ◽

Self Report ◽

Controlled Study ◽

Control Group ◽

Foam Rolling ◽

Randomized Controlled

The present double-blinded, randomized controlled study sought to compare the effects of a full-body manual massage (MM) and a foam rolling (FR) intervention on subjective and objective indexes of performance and well-being. A total of 65 healthy individuals were randomly allocated to an FR, MM, or a control group who received a cognitively oriented relaxation routine. Self-report ratings of perceived anxiety, muscle relaxation, and muscle pain were used to index changes in affect and physical sensations. The sit-and-reach and toe-touch tests, as well as a mental calculation task, were used to index motor and cognitive performances, respectively. We also conducted resting-state electroencephalography and continuous skin conductance recordings before and after the experimental intervention. Both FR and MM groups exhibited neural synchronization of alpha and beta oscillations during the posttest. Skin conductance increased from the pretest to the posttest in the relaxation group, but decreased in the FR group. All interventions improved range of motion, although only the MM group outperformed the relaxation group for the toe-touch performance. MM was associated with reduced muscle pain and increased muscle relaxation. Reduced perceived anxiety after the intervention was observed in the FR group only. Overall, MM and FR both improved objective and subjective indexes of performance and well-being. Differences between the two massage interventions are discussed in relation to the effects of pressure stimulation on autonomic regulations and the proactive vs. retroactive nature of FR, compared to MM.

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The Effects of Aerobic Versus Cognitively Demanding Exercise Interventions on Executive Functioning in School-Aged Children: A Cluster-Randomized Controlled Trial

Journal of Sport and Exercise Psychology ◽

10.1123/jsep.2020-0034 ◽

2020 ◽

pp. 1-13

Author(s):

Anna Meijer ◽

Marsh Königs ◽

Irene M.J. van der Fels ◽

Chris Visscher ◽

Roel J. Bosker ◽

...

Keyword(s):

Physical Activity ◽

Randomized Controlled Trial ◽

Executive Functioning ◽

Exercise Intervention ◽

Controlled Trial ◽

Vigorous Physical Activity ◽

Verbal Working Memory ◽

Control Group ◽

Exercise Interventions ◽

Randomized Controlled

The authors performed a clustered randomized controlled trial to investigate the effects of an aerobic and a cognitively demanding exercise intervention on executive functions in primary-school-age children compared with the regular physical education program (N = 856). They hypothesized that both exercise interventions would facilitate executive functioning, with stronger effects for the cognitively demanding exercise group. The interventions were provided four times per week for 14 weeks. Linear mixed models were conducted on posttest neurocognitive function measures with baseline level as covariate. No differences were found between the exercise interventions and the control group for any of the measures. Independently of group, dose of moderate to vigorous physical activity was positively related to verbal working memory and attention abilities. This study showed that physical exercise interventions did not enhance executive functioning in children. Exposure to moderate to vigorous physical activity is a crucial aspect of the relationship between physical activity and executive functioning.

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Interruzione del trattamento nei pazienti con schizofrenia che ricevono olanzapina o aripiprazolo: metanalisi degli studi clinici controllati

Farmeconomia Health economics and therapeutic pathways ◽

10.7175/fe.v6i1.822 ◽

2005 ◽

Vol 6 (1) ◽

pp. 69-76

Author(s):

Benedetta Santarlasci ◽

Giovanni Biricolti ◽

Cecilia Orsi

Keyword(s):

Treatment Group ◽

Literature Search ◽

Drop Out ◽

Inclusion Criteria ◽

Antipsychotic Therapy ◽

Therapy Discontinuation ◽

Randomized Controlled ◽

Drop Out Rate ◽

Number Of Patients

BACKGROUND: In schizophrenia the drop-out rate can be used as proxy of effectiveness. The drop-out evaluation is also important considering the relevant economic impact for NHS of an antipsychotic therapy discontinuation in terms of patient hospitalization and other related healthcare resources consumption. OBJECTIVE: To analyze the differences in the rates of drop-out from clinical trials between olanzapine and aripiprazole. METHODS: Literature search was based on MEDLINE, on Iowa-IDIS and Drugdex databases (1966-Dec 2004). Analysis included 12 randomized controlled trials (3.778 patients), 8 for olanzapine (2.559 patients) and 4 for aripiprazole (1.219 patients). RCT inclusion criteria were: a) Patients affected by schizophrenia; b) Randomized assignment to olanzapine or aripiprazole treatment group; c) Number of patients included in the treatment group higher than 100; d) Drop-out frequency evaluation between 4th and 26th weeks of follow-up. RESULTS: The rate of treatment discontinuation was greater for aripiprazole than for olanzapine (42,2% vs. 31,6% respectively). The comparison between drop-out percentages is statistically significant (p

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Effects of self-conditioning techniques in promoting weight loss in patients with severe obesity: a randomized controlled trial protocol

International Journal of Clinical Trials ◽

10.18203/2349-3259.ijct20170304 ◽

2017 ◽

Vol 4 (1) ◽

pp. 20 ◽

Cited By ~ 1

Author(s):

Simona Bo ◽

Farnaz Rahimi ◽

Bice Properzi ◽

Giuseppe Regaldo ◽

Ilaria Goitre ◽

...

Keyword(s):

Weight Loss ◽

Standard Care ◽

Traditional Approach ◽

Controlled Trial ◽

Well Being ◽

Control Group ◽

Randomized Controlled ◽

Rapid Induction ◽

Conditioning Approach

Background: Obesity is a worldwide epidemic; most obese individuals who lose weight after lifestyle educative treatments, soon regain it. Our aim is to evaluate the effectiveness of a training to teach self-conditioning technique (self-hypnosis) added to standard care in determining weight loss compared with standard care in patients with obesityMethods: This randomized controlled open trial will recruit 120 obese patients (BMI 35-50 Kg/m2), aged 20-70 years. The control group will receive a traditional approach: diet + exercise + behavioral recommendations. The experimental group will receive self-conditioning techniques + traditional approach.Three individual sessions of hypnosis with rapid-induction techniques will be administered by trained personnel. All the participants of both groups will be assessed at three, six, nine and twelve months after randomization. The primary outcome is weight loss difference between groups at 12 months after randomization; secondary outcomes are changes in adherence to dietetic and exercise recommendations, appetite and satisfaction/well-being, waist circumference and body fat, blood pressure and blood metabolic and inflammatory variables.Conclusions: The results of this trial will assess whether a self-conditioning approach, based on self-hypnosis, is able to help participants to modulate unhealthy patterns of eating and sustain weight loss in the long term.

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Az ortopédiai nagyműtétek során alkalmazott terápiás szuggesztiók hatása a beteg gyógyulására

Orvosi Hetilap ◽

10.1556/650.2018.31213 ◽

2018 ◽

Vol 159 (48) ◽

pp. 2011-2020 ◽

Cited By ~ 1

Author(s):

Csenge Szeverényi ◽

Zoltán Csernátony ◽

Ágnes Balogh ◽

Tünde Simon ◽

Zoltán Kekecs ◽

...

Keyword(s):

Perioperative Period ◽

Well Being ◽

Controlled Study ◽

Control Group ◽

Physician Communication ◽

Replacement Surgery ◽

Randomized Controlled ◽

Medication Consumption ◽

Communication Method ◽

The Mean

Abstract: Introduction and aim: Hip and knee replacement surgery is very demanding for patients. Medication consumption is further increased by perioperative anxiety. Besides pain killer and anxiolytic medications, patients’ recovery can be enhanced by applying therapeutic suggestions, which are easily applicable during the patient–physician communication. Method: In our prospective, randomized, controlled study we examined the effects of positive suggestions on patients undergoing hip or knee arthroplasty in spinal anaesthesia. Members of the suggestion group received the therapeutic suggestions during a pre-surgery physician visit, and by listening to an audio recording during surgery. Results: Compared to the control group (n = 50), in the suggestion group (n = 45) the need of medication (pain killer and adjuvant pain medication) during the surgery was lower (p = 0.037), the mean change from baseline in the well-being of the patients was better on the 2nd [1.31 (0.57; 2.04); p<0.001] and 4th [0.97 (0.23; 1.7); p = 0.011] postoperative day and less transfusion had to be administered (OR: 2.37; p = 0.004). However, there was no difference between the two groups in the postoperative need of medications, in the length of hospitalisation and in the frequency of complications. Conslusion: Our results indicate that the administration of therapeutic suggestions in the perioperative period may be beneficial for orthopaedic surgery patients. Orv Hetil. 2018; 159(48): 2011–2020.

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The Effectiveness of Traditional Chinese Yijinjing Qigong Exercise for the Patients With Knee Osteoarthritis on the Pain, Dysfunction, and Mood Disorder: A Pilot Randomized Controlled Trial

Frontiers in Medicine ◽

10.3389/fmed.2021.792436 ◽

2022 ◽

Vol 8 ◽

Author(s):

Shuaipan Zhang ◽

Guangxin Guo ◽

Xing Li ◽

Fei Yao ◽

Zhiwei Wu ◽

...

Keyword(s):

Knee Osteoarthritis ◽

Outcome Measurement ◽

Controlled Trial ◽

Well Being ◽

Functional Mobility ◽

Exercise Session ◽

Control Group ◽

Serious Adverse Events ◽

Clinical Trial Registration ◽

Randomized Controlled

Background: Although traditional Chinese Yijinjing Qigong Exercise (YJJQE) is popularly used in China, to alleviate symptoms of people with knee osteoarthritis (KOA), no randomized controlled trials (RCTs) are available to evaluate the effects of YJJQE in patients with KOA. The purpose of this trial is to assess the clinical efficacy of YJJQE for patients with KOA.Methods: A total of 50 participants clinically diagnosed with KOA are randomly (1:1) assigned to the YJJQE group (n = 25) and to the stretching training exercise (STE) group (n = 25), for a 40-min exercise session twice a week for 12 weeks. All outcome measures are collected at baseline and at 12-week ending intervention, which includes the primary outcomes of Western Ontario and McMaster Universities Osteoarthritis Index Scale (WOMAC), the secondary outcomes of visual analog scale (VAS), mental component summary (MCS), physical component summary (PCS), Beck depression inventory (BDI), perceived stress scale (PSS), Berg balance scale (BBS), and the Gait functional mobility data.Results: The YJJQE group did not have any significant changes compared to the control group on the WOMAC score after the 12-week intervention (P > 0.05), though the YJJQE group demonstrated better performance in MCS, BDI, and PSS (P = 0.002, P = 0.001, and P = 0.026, respectively) than the control group. No serious adverse events occurred in either group, and only mild muscle soreness was reported during both exercise treatments.Conclusion: Because no difference between both groups was shown, with regards to the primary outcome measurement (WOMAC), it can hardly explain that the YJJQE had an advantageous effect on patients experiencing the pain and dysfunction of knee osteoarthritis. However, compared to the control group, YJJQE appeared to be associated with improvements in psychological well-being including reduced stress, anxiety, depression, and mood disturbance to manage KOA. Further trials with larger sample sizes and follow-up studies will be required.Clinical Trial Registration:https://www.chictr.org.cn/edit.aspx?pid=60357&htm=4, ChiCTR2000037256.

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Harnessing Telehealth to Mitigate the Impact of the COVID-19 Pandemic on Sleep and Well-being: A Randomized Controlled Trial (Preprint)

10.2196/preprints.34409 ◽

2021 ◽

Author(s):

Kathleen P. O'Hora ◽

Raquel A. Osorno ◽

Dena Sadeghi-Bahmani ◽

Mateo Lopez ◽

Allison Morehouse ◽

...

Keyword(s):

Quality Of Life ◽

Randomized Controlled Trial ◽

Early Treatment ◽

Controlled Trial ◽

Well Being ◽

Control Group ◽

Randomized Controlled ◽

The Impact ◽

Insomnia Symptoms

BACKGROUND The COVID-19 Pandemic led to drastic increases in the prevalence and severity of insomnia symptoms. These increases in insomnia complaints have been paralleled by significant decreases in well-being, including increased symptoms of depression, anxiety, and suicidality and decreased quality of life. However, the efficacy and impact of early treatment of insomnia symptoms on future sleep and well-being remains unknown. OBJECTIVE Here, we present the framework and protocol for a novel study that aims to investigate whether a brief telehealth insomnia intervention targeting new insomnia that developed during the pandemic prevents deterioration of well-being, including symptoms of insomnia, depression, anxiety, suicidality, and quality of life. METHODS The protocol details a two-arm randomized controlled trial to investigate the efficacy of a brief, telehealth-delivered, early treatment of insomnia and evaluate its potential to prevent a deterioration of well-being. Participants with clinically significant insomnia symptoms that began during the pandemic are randomized to either a treatment group or a 28-week waitlist control group. Treatment consists of 4 telehealth sessions of Cognitive Behavioral Therapy for Insomnia (CBT-I) delivered over 5 weeks. All participants will complete assessments of insomnia symptom severity, well-being, and daily habits checklist at baseline (week 0), and at weeks 1-6, 12, 28, and 56. RESULTS The trial began enrollment June 3, 2020 and closed enrollment June 17, 2021. As of October 2021, 49 participants have been randomized to either immediate treatment or a 28-week waitlist. 23 participants are still active in the protocol. CONCLUSIONS To our knowledge, this protocol would be represent the first study to test an early sleep intervention for improving insomnia that emerged during the COVID-19 Pandemic. The findings of this study could provide information about the utility of CBT-I for symptoms that emerge in the context of other stressors before they develop a chronic course and deepen understanding of the relationship between sleep and well-being. CLINICALTRIAL NCT04409743

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The effect of Baduanjin exercise for functional ankle instability rehabilitation: study protocol for a randomized controlled pilot trial

10.21203/rs.2.9762/v1 ◽

2019 ◽

Author(s):

Li Zhou ◽

Juanjuan Ai ◽

Kuangshi Li ◽

Yiting Sun ◽

Ruyu Yan ◽

...

Keyword(s):

Physical Therapy ◽

Ankle Instability ◽

Controlled Trial ◽

Pilot Trial ◽

Bilateral Symmetry ◽

Erector Spinae ◽

Control Group ◽

Joint Control ◽

Functional Ankle Instability ◽

Randomized Controlled

Abstract Background Patients with functional ankle instability (FAI) have problems with joint control, balance, gait, and postural symmetry. Baduanjin is a type of traditional Chinese exercise, which has been shown to be effective for treating many diseases and symptoms. However, the effect of Baduanjin in patients with FAI has not been proved. This trial is an assessor-blinded randomized controlled trial (RCT), its objective is to study the efficacy and safety of Baduanjin on the rehabilitation of patients with FAI. Methods Seventy-two participants, who are eligible according to the inclusion and exclusion criteria, will be randomized (in a 1:1 ratio) using a random numbers table into two groups: a Baduanjin group and a control group (subjected to conventional physical therapy). The Baduanjin group will be subjected to Baduanjin exercise in addition to the conventional physical therapy. The participants’ exercise will be implemented for 4 weeks (5 days a week). All the participants will be assessed at baseline, after 2 weeks’ treatment, and after 4 weeks’ treatment (after the intervention). The efficacy of Baduanjin will be assessed based on three types of outcome: (1) surface electromyography (sEMG) results of the bilateral erector spinae, tibialis anterior, and peroneus longus; (2) balance function under different conditions; and (3) the severity of ankle instability in daily life, using the Cumberland Ankle Instability Tool (CAIT). Discussion The aim of the trial is to study the effect and safety of Baduanjin in patients with FAI. The study findings may show whether Baduanjin could be used to complement medical FAI rehabilitation methods. The study findings could also highlight the importance of Baduanjin in promoting the bilateral symmetry of motor function.

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