Short-term aerobic training does not improve memory functioning in relapsing remitting multiple sclerosis – a randomized controlled trial

AbstractBackgroundOnly few aerobic exercise intervention trials specifically targeting cognitive functioning have been performed in MS.Objective and methodsThis randomized controlled trial aimed to determine the effects of aerobic exercise on cognition in relapsing-remitting MS. The primary outcome was verbal memory (Verbal learning and memory test, VLMT). Patients were randomized to an intervention group (IG) program or a waitlist control group (CG). Patients in the IG exercised according to an individually tailored training schedule (with 2-3 sessions per week for 12 weeks). The primary analysis was carried out using the intention-to-treat (ITT) sample with ANCOVA adjusting for baseline scores.Results77 RRMS patients were screened and 68 participants randomized (CG n=34; IG n=34). The sample comprised 68% females, had a mean age of 39 years, a mean disease duration of 6.3 years, and a mean EDSS of 1.8. No significant effects were detected in the ITT analysis for the primary endpoint VLMT or any other cognitive measures. Moreover, no significant treatment effects were observed for quality of life, fatigue, or depressive symptoms.ConclusionThis study failed to demonstrate beneficial effects of aerobic exercise on cognition in RRMS.The trial was prospectively registered at clinicaltrials.gov (NCT02005237).

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Short-term interval aerobic exercise training does not improve memory functioning in relapsing-remitting multiple sclerosis—a randomized controlled trial

PeerJ ◽

10.7717/peerj.6037 ◽

2018 ◽

Vol 6 ◽

pp. e6037 ◽

Cited By ~ 8

Author(s):

Lisa Baquet ◽

Helge Hasselmann ◽

Stefan Patra ◽

Jan-Patrick Stellmann ◽

Eik Vettorazzi ◽

...

Keyword(s):

Multiple Sclerosis ◽

Randomized Controlled Trial ◽

Aerobic Exercise ◽

Controlled Trial ◽

Verbal Learning ◽

Control Group ◽

Randomized Controlled ◽

Relapsing Remitting ◽

Remitting Multiple Sclerosis ◽

Relapsing Remitting Multiple Sclerosis

Background Only few aerobic exercise intervention trials specifically targeting cognitive functioning have been performed in multiple sclerosis. Objective and Methods This randomized controlled trial with 34 patients in the intervention group (IG) (mean: 38.2 years (±9.6)) and 34 patients in the control group (CG) (mean: 39.6 years (±9.7)) aimed to determine the effects of aerobic exercise on cognition in relapsing-remitting multiple sclerosis (RRMS). The primary outcome was verbal learning assessed by the verbal learning and memory test (VLMT). Patients were randomized to an IG or a waitlist CG. Patients in the IG exercised according to an individually tailored training schedule (with two to three sessions per week for 12 weeks). The primary analysis was carried out using the intention-to-treat (ITT) sample with ANCOVA adjusting for baseline scores. Results A total of 77 patients with RRMS were screened and 68 participants randomized (CG n = 34; IG n = 34). The sample comprised 68% females, had a mean age of 39 years, a mean disease duration of 6.3 years, and a mean expanded disability status scale of 1.8. No significant effects were detected in the ITT analysis for the primary endpoint VLMT or any other cognitive measures. Moreover, no significant treatment effects were observed for quality of life, fatigue, or depressive symptoms. Conclusion This study failed to demonstrate beneficial effects of aerobic exercise on cognition in RRMS. The trial was prospectively registered at clinicaltrials.gov (NCT02005237).

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Effectiveness of Yijinjing on Cognitive Functions in Post-stroke Patients With Mild Cognitive Impairment: Study Protocol for a Randomized Controlled Trial

10.21203/rs.3.rs-204458/v1 ◽

2021 ◽

Author(s):

Xin Xue ◽

Xue-Xing Jin ◽

Kai-Liang Luo ◽

Xin-Hao Liu ◽

Li Zhang ◽

...

Keyword(s):

Randomized Controlled Trial ◽

Cognitive Functions ◽

Exercise Intervention ◽

Controlled Trial ◽

Intervention Group ◽

Control Group ◽

Stroke Patients ◽

Post Stroke ◽

Randomized Controlled

Abstract Background: Statistics show that every year, 5.4 million people in the world suffer a stroke. Post-stroke cognitive impairment (PSCI) is one of the most common complications after stroke with a rate of 75%, which leads to decreased functions for independent living and reduced quality of life (QOL). Exercise training has been reported to be useful to improve the cognitive functions of post-stroke patients. Yijinjing, a traditional Chinese Qigong exercise characterized by an integration of mind and body in moderate exercise intensity, can improve cognitive functions of PSCI patients. This study aims to explore the feasibility and effectiveness of the Yijinjing exercise in this regard.Methods: A single-blind, randomized controlled trial will be employed with evaluations at three and six months. 72 PSCI patients will be recruited and randomly assigned to the Yijinjing exercise intervention group or the control group (1:1). Participants in the control group will receive routine rehabilitation therapies, including occupational therapy, physical therapy, acupuncture therapy, and health education 5 times a week for 3 months. The intervention group will receive a 12-week routine rehabilitation therapy combined with the Yijinjing exercise intervention for 40 minutes each session and 3 sessions a week. The primary outcome of cognition will be measured by the Montreal Cognitive Assessment scale (MoCA). Secondary outcomes include executive function, memory function, visuospatial function, sleep quality, gait and motor function, activity of daily living (ADL), and quality of life (QOL).Discussion: Current evidence has reported the effectiveness of traditional Chinese exercise in improving the post-stroke population’s motor functions. This research is a randomized controlled trial that evaluates traditional Chinese exercise’s effectiveness for PSCI patients. It is expected to expand the traditional Chinese exercise scope and provide a new treatment approach for stroke populations with cognitive impairments.Trail registration: Chinese Clinical Trial Registry, ChiCTR1900026532. Registered on 13 October 2019.

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Effectiveness of Yijinjing on cognitive functions in post-stroke patients with mild cognitive impairment: study protocol for a randomized controlled trial

Trials ◽

10.1186/s13063-021-05220-w ◽

2021 ◽

Vol 22 (1) ◽

Author(s):

Xin Xue ◽

Xue-Ming Jin ◽

Kai-Liang Luo ◽

Xin-Hao Liu ◽

Li Zhang ◽

...

Keyword(s):

Randomized Controlled Trial ◽

Cognitive Functions ◽

Exercise Intervention ◽

Controlled Trial ◽

Intervention Group ◽

Control Group ◽

Stroke Patients ◽

Post Stroke ◽

Randomized Controlled

Abstract Background Statistics show that every year, 5.4 million people in the world suffer a stroke. Post-stroke cognitive impairment (PSCI) is one of the most common complications after stroke with a rate of 75%, which leads to decreased functions for independent living and reduced quality of life (QOL). Exercise training has been reported to be useful to improve the cognitive functions of post-stroke patients. Yijinjing, a traditional Chinese Qigong exercise characterized by an integration of mind and body in moderate exercise intensity, can improve cognitive functions of PSCI patients. This study aims to explore the feasibility and effectiveness of the Yijinjing exercise in this regard. Methods A single-blind, superiority, randomized controlled trial will be employed with evaluations at 3 and 6 months. Seventy-two PSCI patients will be recruited and randomly assigned to the Yijinjing exercise intervention group or the control group (1:1). Participants in the control group will receive routine rehabilitation therapies, including occupational therapy, physical therapy, acupuncture therapy, and health education 5 times a week for 3 months. The intervention group will receive a 12-week routine rehabilitation therapy combined with the Yijinjing exercise intervention for 40 min each session and 3 sessions a week. The primary outcome of cognition will be measured by the Montreal Cognitive Assessment scale (MoCA). Secondary outcomes include executive function, memory function, visuospatial function, sleep quality, gait and motor function, activity of daily living (ADL), and quality of life (QOL). Discussion Current evidence has reported the effectiveness of traditional Chinese exercise in improving the post-stroke population’s motor functions. This research is a randomized controlled trial that evaluates traditional Chinese exercise’s effectiveness for PSCI patients. It is expected to expand the traditional Chinese exercise scope and provide a new treatment approach for stroke populations with cognitive impairments. Trial registration Chinese Clinical Trial Registry ChiCTR1900026532. Registered on 13 October 2019.

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Moderators of Maintained Increase in Aerobic Exercise Among Aging Men and Women in a 4-Year Randomized Controlled Trial: The DR’s EXTRA Study

Journal of Physical Activity and Health ◽

10.1123/jpah.2014-0299 ◽

2015 ◽

Vol 12 (11) ◽

pp. 1477-1484 ◽

Cited By ~ 1

Author(s):

Leena Hakola ◽

Kai Savonen ◽

Pirjo Komulainen ◽

Maija Hassinen ◽

Rainer Rauramaa ◽

...

Keyword(s):

Randomized Controlled Trial ◽

Aerobic Exercise ◽

Controlled Trial ◽

Intervention Group ◽

Exercise Group ◽

Control Group ◽

Older Individuals ◽

Men And Women ◽

Exercise Interventions ◽

Randomized Controlled

Background:Little is known about factors that modify the effectiveness of exercise interventions in increasing exercise. We aimed to identify moderators of the effectiveness of aerobic exercise intervention in maintaining increased aerobic exercise among older individuals.Methods:The participants of a 4-year randomized controlled trial were a population sample of 1410 men and women aged 57 to 78 years. The aerobic exercise group included 185 individuals and the control group included 169 individuals who reported low aerobic exercise at baseline. Maintained increase in aerobic exercise was defined as at least 60-minute increase in moderate-to-heavy aerobic exercise per week from baseline to 2- and 4-year assessments.Results:Individuals in the aerobic exercise group were 2.5 (95% CI 1.5 to 3.9) times more likely to maintain increased aerobic exercise than those in the control group. Individuals aged < 68.5 years but not older individuals succeeded in maintaining increased aerobic exercise in the intervention group (P = .02 for interaction). Individuals who were past smokers (P = .02 for interaction), were working (P = .05 for interaction), or had symptoms of depression (P = .05 for interaction) succeeded better in maintaining increased aerobic exercise in the intervention group than other individuals.Conclusions:These findings help in more precise targeting of future exercise interventions among older individuals.

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Can Muscle Mass Be Maintained with A Simple Resistance Intervention in the Older People? A Cluster Randomized Controlled Trial in Thailand

International Journal of Environmental Research and Public Health ◽

10.3390/ijerph19010140 ◽

2021 ◽

Vol 19 (1) ◽

pp. 140

Author(s):

Bumnet Saengrut ◽

Takeshi Yoda ◽

Yumi Kimura ◽

Yasuko Ishimoto ◽

Rujee Rattanasathien ◽

...

Keyword(s):

Randomized Controlled Trial ◽

Older People ◽

Muscle Mass ◽

Exercise Intervention ◽

Controlled Trial ◽

Intervention Group ◽

Community Dwelling ◽

Control Group ◽

Randomized Controlled ◽

Physiological Outcomes

The aging population is rapidly increasing worldwide. Sarcopenia is a common and important health problem among older people. The prevalence of sarcopenia among older Thai adults is increasing. Exercise intervention for sarcopenia prevention may significantly improve muscle strength, body balance, and muscle mass. Therefore, this study aimed to investigate the effects of a simple resistance intervention (SRI) program in preventing sarcopenia on physiological outcomes among community-dwelling older Thai adults. This study was a 12-week randomized controlled trial, which included 80 community-dwelling older adults in Chiang Mai, Thailand, who were randomly assigned into control (40 participants who performed usual exercise) and intervention (40 participants who performed the SRI program) groups. The SRI program was a home-based program consisting of 30 min of resistance exercise three times/week for 12 weeks, health education on sarcopenia. After 12 weeks, all physiological outcomes were measured and were significantly improved in the intervention group compared with baseline; hand grip, skeletal muscle mass index, and walking speed were significantly improved in the intervention group compared with the control group. Based on our results, the SRI program may prevent muscle weakness in community-dwelling older people in Thailand.

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Effectiveness of a web-based medication adherence tool with patient centered communication: Results of a clustered randomized controlled trial (Preprint)

10.2196/preprints.16141 ◽

2019 ◽

Author(s):

Jan van Lieshout ◽

Joyca Lacroix ◽

Aart van Halteren ◽

Martina Teichert

Keyword(s):

Randomized Controlled Trial ◽

Medication Adherence ◽

Controlled Trial ◽

Intervention Group ◽

Control Group ◽

Community Pharmacies ◽

Web Based ◽

Randomized Controlled ◽

Tailored Interventions ◽

Increased Risk

BACKGROUND Growing numbers of people use medication for chronic conditions; non-adherence is common, leading to poor disease control. A newly developed web-based tool to identify an increased risk for non-adherence with related potential individual barriers might facilitate tailored interventions and improve adherence. OBJECTIVE To assess the effectiveness of the newly developed tool to improve medication adherence. METHODS A cluster randomized controlled trial assessed the effectiveness of this adherence tool in patients initiating cardiovascular or oral blood glucose lowering medication. Participants were included in community pharmacies. They completed an online questionnaire comprising an assessments of their risk for medication non-adherence and subsequently of barriers to adherence. In pharmacies belonging to the intervention group, individual barriers displayed in a graphical profile on a tablet were discussed by pharmacists and patients at high non-adherence risk in face to face meetings and shared with their general practitioners and practice nurses. Tailored interventions were initiated by the healthcare providers. Barriers of control patients were not presented or discussed and these patients received usual care. The primary outcome was the difference in medication adherence at 8 months follow-up between patients with an increased non-adherence risk from intervention and control group, calculated from dispensing data. RESULTS Data from 492 participants in 15 community pharmacies were available for analyses (intervention 253, 7 pharmacies; control 239, 8 pharmacies). The intervention had no effect on medication adherence (-0.01; 95%CI -0.59 – 0.57; P= .96), neither in the post hoc per protocol analysis (0.19; 95%CI -0.50 – 0.89; P=.58). CONCLUSIONS This study showed no effectiveness of a risk stratification and tailored intervention addressing personal barriers for medication adherence. Various potential explanations for lack of effect were identified. These explanations relate for instance to high medication adherence in the control group, study power and fidelity. Process evaluation should elicit possible improvements and inform the redesign of intervention and implementation. CLINICALTRIAL The Netherlands National Trial Register: NTR5186. Date: May 18, 2015 (http://www.trialregister.nl/trialreg/admin/rctview.asp?TC=5186)

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Effect of leg wrapping technique on prevention of spinal induced hypotension and fetal acidosis during cesarean section: Randomized controlled trial

Journal of Nursing Education and Practice ◽

10.5430/jnep.v10n2p70 ◽

2019 ◽

Vol 10 (2) ◽

pp. 70

Author(s):

Samah Nasser Abd El-Aziz El-Shora ◽

Amina Mohamed Rashad El-Nemer

Keyword(s):

Randomized Controlled Trial ◽

Cesarean Section ◽

Controlled Trial ◽

Intervention Group ◽

Cost Effective ◽

Control Group ◽

Induced Hypotension ◽

Randomized Controlled ◽

Significant Difference ◽

Wrapping Technique

Background and aim: Hypotension during cesarean section (CS) under spinal anesthesia has been a subject of scientific study for more than 50 years and the search for the most effective strategy to achieve hemodynamic stability remains challenging. Aim: The study was carried out to apply leg wrapping technique for the prevention of spinal-induced hypotension (SIH) during CS.Methods: Randomized Controlled Trial design was utilized at cesarean delivery operating room Mansoura General Hospital in El-Mansoura City during the period from May 2018 to November 2018. A purposive sample of 88 pregnant women, assigned randomly to an intervention group (n = 44) in which their legs wrapped with elastic crepe bandage and control group (n = 44) in which no wrapping was done. Data collected for maternal, neonatal hemodynamic and signs of hypotension, the feasibility of application and cost analysis.Results: There was a statistically significant difference in the incidence of SIH and Ephedrine use among both groups (18.20% in leg wrapping group whereas 75% in control group). In addition, neonatal acidosis and NICU admission were less among leg wrapping group (11.40%, 9.10% respectively). Economically, leg wrapping technique was cost effective compared to the cost of the hospital regimen for treating SIH and admission to (NICU).Conclusion and recommendations: Leg wrapping technique was cost effective and an efficient method for decreasing SIH, neonatal acidosis and Ephedrine administration. It is recommended to apply leg wrapping technique in maternal hospitals' protocol of care for decreasing SIH during CS.

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Investigating the Impact of Cognitive Training for Individuals With Bothersome Tinnitus: A Randomized Controlled Trial

Otolaryngology ◽

10.1177/0194599821994742 ◽

2021 ◽

pp. 019459982199474

Author(s):

Maggie Xing ◽

Dorina Kallogjeri ◽

Jay F. Piccirillo

Keyword(s):

Randomized Controlled Trial ◽

Cognitive Training ◽

Mixed Model ◽

Controlled Trial ◽

Intervention Group ◽

Control Group ◽

Functional Index ◽

Open Label ◽

Randomized Controlled ◽

The Impact

Objective To evaluate the effectiveness of cognitive training in improving tinnitus bother and to identify predictors of patient response. Study Design Prospective open-label randomized controlled trial. Setting Online. Methods Participants were adults with subjective idiopathic nonpulsatile tinnitus causing significant tinnitus-related distress. The intervention group trained by using auditory-intensive exercises for 20 minutes per day, 5 days per week, for 8 weeks. The active control group trained on the same schedule with non–auditory intensive games. Surveys were completed at baseline, 8 weeks, and 12 weeks. Results A total of 64 participants completed the study. The median age was 63 years (range, 25-69) in the intervention group and 61 years (34-68) in the control group. Mixed model analysis revealed that within-subject change in Tinnitus Functional Index in the intervention group was not different than the control group, with marginal mean differences (95% CI): 0.24 (–11.20 to 10.7) and 2.17 (–8.50 to 12.83) at 8 weeks and 2.33 (–8.6 to 13.3) and 3.36 (–7.91 to 14.6) at 12 weeks, respectively. When the 2 study groups were compared, the control group had higher Tinnitus Functional Index scores than the intervention group by 10.5 points at baseline (95% CI, –0.92 to 29.89), 8.1 at 8 weeks (95% CI, –3.27 to 19.42), and 9.4 at 12 weeks (95% CI, –2.45 to 21.34). Conclusion Auditory-intensive cognitive training was not associated with changes in self-reported tinnitus bother. Given the potential for neuroplasticity to affect tinnitus, we believe that future studies on cognitive training for tinnitus remain relevant.

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Community Health Workers as a Strategy to Tackle Psychosocial Suffering Due to Physical Distancing: A Randomized Controlled Trial

International Journal of Environmental Research and Public Health ◽

10.3390/ijerph18063097 ◽

2021 ◽

Vol 18 (6) ◽

pp. 3097

Author(s):

Dorien Vanden Bossche ◽

Susan Lagaert ◽

Sara Willems ◽

Peter Decat

Keyword(s):

Randomized Controlled Trial ◽

Community Health ◽

Health Workers ◽

Psychosocial Support ◽

Controlled Trial ◽

Intervention Group ◽

Psychosocial Health ◽

Control Group ◽

Randomized Controlled ◽

The Impact

Background: During the COVID-19 pandemic, many primary care professionals were overburdened and experienced difficulties reaching vulnerable patients and meeting the increased need for psychosocial support. This randomized controlled trial (RCT) tested whether a primary healthcare (PHC) based community health worker (CHW) intervention could tackle psychosocial suffering due to physical distancing measures in patients with limited social networks. Methods: CHWs provided 8 weeks of tailored psychosocial support to the intervention group. Control group patients received ‘care as usual’. The impact on feelings of emotional support, social isolation, social participation, anxiety and fear of COVID-19 were measured longitudinally using a face-to-face survey to determine their mean change from baseline. Self-rated change in psychosocial health at 8 weeks was determined. Results: We failed to find a significant effect of the intervention on the prespecified psychosocial health measures. However, the intervention did lead to significant improvement in self-rated change in psychosocial health. Conclusions: This study confirms partially the existing evidence on the effectiveness of CHW interventions as a strategy to address mental health in PHC in a COVID context. Further research is needed to elaborate the implementation of CHWs in PHC to reach vulnerable populations during and after health crises.

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Adherence to a Lifestyle Exercise and Nutrition Intervention in University Employees during the COVID-19 Pandemic: A Randomized Controlled Trial

International Journal of Environmental Research and Public Health ◽

10.3390/ijerph18147510 ◽

2021 ◽

Vol 18 (14) ◽

pp. 7510

Author(s):

Guillermo García Pérez de Sevilla ◽

Olga Barceló Guido ◽

María de la Paz De la Cruz ◽

Ascensión Blanco Fernández ◽

Lidia B. Alejo ◽

...

Keyword(s):

Randomized Controlled Trial ◽

Effect Size ◽

Exercise Intervention ◽

Controlled Trial ◽

Intervention Group ◽

Nutrition Intervention ◽

Sitting Time ◽

Post Intervention ◽

University Employees ◽

Randomized Controlled

Healthy lifestyles should be encouraged in the workplace through the occupational health teams of the companies. The objective of the present study was to evaluate the adherence to a lifestyle intervention carried out in university employees during the COVID-19 pandemic and its impact on health-related quality of life (HrQoL). A randomized controlled trial following the CONSORT guidelines was performed, consisting of three supervised interventions lasting for 18 weeks: an educational intervention on healthy habits, a nutritional intervention, and a telematic aerobic and strength exercise intervention. Lifestyle and HrQoL were analyzed six months post-intervention to assess adherence. Twenty-three middle-aged participants completed the study. The intervention group significantly improved their lifestyle according to the Health Promoting Lifestyle Profile II questionnaire, especially in the categories of Health Responsibility, Physical Activity, and Nutrition, with a large effect size. Sitting time was reduced by 2.5 h per day, with a moderate effect size. Regarding HrQoL, the intervention group showed a clinically significant improvement in the Physical Component Summary. Despite the lockdown and the mobility restrictions caused by the COVID-19 pandemic, this intervention performed on university employees achieved adherence to a healthier lifestyle and improved their HrQoL, which is of great clinical relevance.

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