Dataset Information

Effects of yoga on well-being and healthy ageing: study protocol for a randomised controlled trial (FitForAge).

ABSTRACT:

Introduction

Due to ageing populations worldwide, the burden of disability is increasing. It is therefore important to develop interventions that improve healthy ageing, reduce disability onset and enhance life quality. Physical activity can promote healthy ageing and help maintain independence, yet many older adults are inactive. Yoga is a form of physical activity that aims to improve health and may be particularly suitable for older adults. Research indicates positive effects of yoga on several health-related outcomes; however, empirical studies examining the benefits of yoga on well-being among the elderly remain scarce. This study protocol reports the methodology for a 12-week yoga programme aimed to improve health and well-being among physically inactive older adults.

Methods and analysis

Three group parallel, single-blind randomised controlled trial. Two comparison groups are included: aerobic exercise and a non-active wait-list control. In total, 180 participants aged 65-85 years will be recruited. Assessments will be performed at baseline and postintervention (12-week follow-up). The primary outcome is subjective well-being. Secondary outcomes include physical activity/sedentary behaviour, mobility/fall risk, cognition, depression, anxiety, mood, stress, pain, sleep quality, social support and cardiometabolic risk factors. Data will be analysed using intention-to-treat analyses, with mixed linear modelling.

Ethics and dissemination

This study is approved by the Ethical Review Board in Stockholm (2017/1862-31/2). All participants must voluntarily agree to participate and are free to withdraw from the study at any point. Written informed consent will be obtained from each participant prior to inclusion. Results will be available through research articles and conferences. A summary of key results will be publicly available through newspaper articles.

Trial registration number

DRKS00015093, U1111-1217-4248.

SUBMITTER: Osth J

PROVIDER: S-EPMC6549603 | biostudies-literature | 2019 May

REPOSITORIES: biostudies-literature

ACCESS DATA

Publications

Effects of yoga on well-being and healthy ageing: study protocol for a randomised controlled trial (FitForAge).

Östh Josefine J Diwan Vinod V Jirwe Maria M Diwan Vishal V Choudhary Anita A Mahadik Vijay Khanderao VK Pascoe Michaela M Hallgren Mats M

BMJ open 20190529 5

<h4>Introduction</h4>Due to ageing populations worldwide, the burden of disability is increasing. It is therefore important to develop interventions that improve healthy ageing, reduce disability onset and enhance life quality. Physical activity can promote healthy ageing and help maintain independence, yet many older adults are inactive. Yoga is a form of physical activity that aims to improve health and may be particularly suitable for older adults. Research indicates positive effects of yoga ...[more]

PMID: 31147363

Similar Datasets

Project description:IntroductionThe conceptualisation of healthy ageing phenotype (HAP) and the availability of a tentative panel for HAP biomarkers raise the need to test the efficacy of potential interventions to promote health in older adults. This study protocol reports the methodology for a 24-week programme to explore the holistic influence of the yoga-based intervention on the (bio)markers of HAP.Methods and analysisThe study is a two-armed, randomised waitlist controlled trial with blinded outcome assessors and multiple primary outcomes. We aim to recruit 250 subjects, aged 60-80 years from the residential communities and old age clubs in Bangalore city, India, who will undergo randomisation into intervention or control arms (1:1). The intervention will include a yoga-based programme tailored for the older adults, 1 hour per day for 6 days a week, spread for 24 weeks. Data would be collected at the baseline and post-intervention, the 24th week. The multiple primary outcomes of the study are the (bio)markers of HAP: glycated haemoglobin, low-density lipoprotein cholesterol (LDL-C), systolic blood pressure, and forced expiratory volume in 1 s for physiological and metabolic health; Digit Symbol Substitution Test, Trail Making Tests A and B for cognition; hand grip strength and gait speed for physical capability; loneliness for social well-being and WHO Quality of Life Instrument-Short Form for quality of life. The secondary outcomes include inflammatory markers, tumour necrosis factor-alpha receptor II, C reactive protein, interleukin 6 and serum Klotho levels. Analyses will be by intention-to-treat and the holistic impact of yoga on HAP will be assessed using global statistical test.Ethics and disseminationThe study is approved by the Institutional Ethics Committee of Swami Vivekananda Yoga Anusandhana Samsthana University, Bangalore (ID: RES/IEC-SVYASA/143/2019). Written informed consent will be obtained from each participant prior to inclusion. Results will be available through research articles and conferences.Trial registration numberCTRI/2021/02/031373.

Project description:BackgroundUniversities around the world are facing an epidemic of mental distress among their students. The problem is truly a public health issue, affecting many and with serious consequences. The global burden of disease-agenda calls for effective interventions with lasting effects that have the potential to improve the mental health of young adults. In this study we aimed to determine whether yoga, a popular and widely available mind-body practice, can improve student mental health.MethodsWe performed a randomised controlled trial with 202 healthy university students in the Oslo area. The participants were assigned to a yoga group or waitlist control group in a 1:1 ratio by a simple online randomisation program. The intervention group was offered 24 yoga sessions over 12 weeks. Measurements were taken at week 0 (baseline), week 12 (post-intervention), and week 24 (follow-up). The primary outcome was psychological distress assessed by the HSCL-25 questionnaire. Analysis was performed based on the intention to treat-principle.ResultsBetween 24 January 2017, and 27 August 2017, we randomly assigned 202 students to a yoga intervention group (n = 100), or waitlist control group (n = 102). Compared with the control group, the yoga participants demonstrated a significant reduction in distress symptoms both at post-intervention (adjusted difference in the mean change -0.15, 95% CI -0.26 to -0.03, p = 0.0110) and follow-up (adjusted difference in the mean change -0.18, 95% CI -0.29 to -0.06, p = 0.0025). Sleep quality also improved at post-intervention and follow-up. No adverse events were reported.ConclusionsOur findings suggest that yoga has a moderately large and lasting effect, at least for some months, reducing symptoms of distress and improving sleep quality among students. Further research should seek ways to enhance the effect, assess an even longer follow-up period, include active control groups, and consider performing similar studies in other cultural settings.Trial registration: ClinicalTrials.gov identifier: NCT04258540.

Project description:BackgroundSuccessful implementation and long-term maintenance of healthy supermarkets initiatives are crucial to achieving potential population health benefits. Understanding barriers and enablers of implementation of real-world trials will enhance wide-scale implementation. This process evaluation of a healthy supermarket intervention sought to describe (i) customer, retailer and stakeholder perspectives on the intervention; (ii) intervention implementation; and (iii) implementation barriers and enablers.MethodsEat Well @ IGA was a 12-month randomised controlled trial conducted in 11 Independent Grocers of Australia (IGA) chain supermarkets in regional Victoria, Australia (5 intervention and 6 wait-listed control stores). Intervention components included trolley and basket signage, local area and in-store promotion, and shelf tags highlighting the healthiest packaged foods. A sequential mixed-methods process evaluation was undertaken. Customer exit surveys investigated demographics, and intervention recall and perceptions. Logistic mixed-models estimated associations between customer responses and demographics, with store as random effect. Supermarket staff surveys investigated staff demographics, interactions with customers, and intervention component feedback. Semi-structured stakeholder interviews with local government, retail and academic partners explored intervention perceptions, and factors which enabled or inhibited implementation, maintenance and scalability. Interviews were inductively coded to identify key themes.ResultsOf 500 customers surveyed, 33%[95%CI:23,44] recalled the Eat Well @ IGA brand and 97%[95%CI:93,99] agreed that IGA should continue its efforts to encourage healthy eating. The 82 staff surveyed demonstrated very favourable intervention perceptions. Themes from 19 interviews included that business models favour sales of unhealthy foods, and that stakeholder collaboration was crucial to intervention design and implementation. Staff surveys and interviews highlighted the need to minimise staff time for project maintenance and to regularly refresh intervention materials to increase and maintain salience among customers.ConclusionsThis process evaluation found that interventions to promote healthy diets in supermarkets can be perceived as beneficial by retailers, customers, and government partners provided that barriers including staff time and intervention salience are addressed. Collaborative partnerships in intervention design and implementation, including retailers, governments, and academics, show potential for encouraging long-term sustainability of interventions.Trial registrationISRCTN, ISRCTN37395231 Registered 4 May 2017.

Project description:Stroke is a major public health threat globally. Psychosocial well-being may be affected following stroke. Depressive symptoms, anxiety, general psychological distress and social isolation are prevalent. Approximately one third report depressive symptoms and 20% report anxiety during the first months or years after the stroke. Psychosocial difficulties may impact significantly on long-term functioning and quality of life, reduce the effects of rehabilitation services and lead to higher mortality rates. The aim of the study is to evaluate the effect of a previously developed and feasibility tested dialogue-based psychosocial intervention aimed at promoting psychosocial well-being and coping following stroke among stroke survivors with and without aphasia.The study will be conducted as a multicenter, randomized, single blind controlled trial with one intervention and one control arm. It will include a total of 330 stroke survivors randomly allocated into either an intervention group (dialogue-based intervention to promote psychosocial well-being) or a control group (usual care). Participants in the intervention group will receive eight individual sessions of supported dialogues in their homes during the first six months following an acute stroke. The primary outcome measure will be psychosocial well-being measured by the General Health Questionnaire (GHQ). Secondary outcome measures will be quality of life (SAQoL), sense of coherence (SOC), and depression (Yale). Process evaluation will be conducted in a longitudinal mixed methods study by individual qualitative interviews with 15-20 participants in the intervention and control groups, focus group interviews with the intervention personnel and data collectors, and a comprehensive analysis of implementation fidelity.The intervention described in this study protocol is based on thorough development and feasibility work, guided by the UK medical research council framework for developing and testing complex interventions. It combines classical effectiveness evaluation with a thorough process evaluation. The results from this study may inform the development of further trials aimed at promoting psychosocial well-being following stroke as well as inform the psychosocial follow up of stroke patients living at home.NCT02338869 ; registered 10/04/2014 (On-going trial).

Project description:IntroductionA huge population in India is at high risk of type-2 diabetes (T2DM). Physical activity and a healthy diet (healthy lifestyle) improve blood glucose levels in people at high risk of T2DM. However, an unhealthy lifestyle is common among Indians. Yoga covers physical activity and a healthy diet and can help to prevent T2DM. The research question to be addressed by the main randomised controlled trial (RCT) is whether a Yoga programme for T2DM prevention (YOGA-DP) is effective in preventing T2DM among high risk people in India as compared with enhanced standard care. In this current study, we are determining the feasibility of undertaking the main RCT.InterventionYOGA-DP is a structured lifestyle education and exercise programme. The exercise part is based on Yoga and includes Shithilikarana Vyayama (loosening exercises), Surya Namaskar (sun salutation exercises), Asana (Yogic poses), Pranayama (breathing practices) and Dhyana (meditation) and relaxation practices.Methods and analysisThis is a multicentre, two-arm, parallel-group, feasibility RCT with blinded outcome assessment and integrated mixed-methods process evaluation. Eligible participants should be aged 18-74 years, at high risk of T2DM (fasting plasma glucose level 5.6-6.9 mmol/L) and safe to participate in physical activities. At least 64 participants will be randomised to intervention or control group with final follow-up at 6 months. Important parameters, needed to design the main RCT, will be estimated, such as SD of the outcome measure (fasting plasma glucose level at 6-month follow-up), recruitment, intervention adherence, follow-up, potential contamination and time needed to conduct the study. Semistructured qualitative interviews will be conducted with up to 20-30 participants, a sample of those declining to participate, four YOGA-DP instructors and around eight study staff to explore their perceptions and experiences of taking part in the study and of the intervention, reasons behind non-participation, experiences of delivering the intervention and running the study, respectively.Ethics and disseminationEthics approval has been obtained from the following Research Ethics Committees: Faculty of Medicine and Health Sciences, University of Nottingham (UK); Centre for Chronic Disease Control (CCDC, India); Bapu Nature Cure Hospital and Yogashram (BNCHY, India) and Swami Vivekananda Yoga Anusandhana Samsthana (S-VYASA, India). The results will be widely disseminated among key stakeholders through various avenues.Trial registration numberCTRI/2019/05/018893.

Project description:INTRODUCTION:The singing for people with aphasia (SPA) intervention aims to improve quality of life and well-being for people with poststroke aphasia. A definitive randomised controlled trial (RCT) is required to assess the clinical and cost effectiveness of SPA. The purpose of this pilot study is to assess the feasibility of such a definitive trial and inform its design. METHODS AND ANALYSIS:A two-group, assessor-blinded, randomised controlled external pilot trial with parallel mixed methods process evaluation and economic evaluation. Forty-eight participants discharged from clinical speech and language therapy will be individually randomised 1:1 to SPA (10 group sessions plus a resource booklet) or control (resource booklet only). Outcome assessment at baseline, 3 and 6 months postrandomisation include: ICEpop CAPability measure for adults, Stroke and Aphasia Quality of Life, EQ-5D-5L, modified Reintegration into Normal Living Index, Communication Outcome After Stroke, Very Short Version of the Minnesota Aphasia Test, Service Receipt Inventory and Care Related Quality of Life. Feasibility, acceptability and process outcomes include recruitment and retention rates, with measurement burden and trial experiences being explored in qualitative interviews (15 participants, 2 music facilitators and 2 music champions). Analyses include: descriptive statistics, with 95% CIs where appropriate; qualitative themes; intervention fidelity from videos and session checklists; rehearsal of health economic analysis. ETHICS AND DISSEMINATION:NHS National Research Ethics Service and the Health Research Authority confirmed approval in April 2017; recruitment commenced in June 2017. Outputs will include: pilot data to inform whether to proceed to a definitive RCT and support a funding application; finalised intervention manual for multicentre replication of SPA; presentations at conferences, public involvement events; internationally recognised peer reviewed journal publications, open access sources and media releases. TRIAL REGISTRATION NUMBER:NCT03076736.

Project description:Traditionally, yoga is a multicomponent practice consisting of postures, breathing techniques, meditation, mantras, and ethics. To date, only a few studies have tried to dismantle the effects of each of these components and their combinations. To fill this gap, we examined the incremental effects of ethical education and physical Hatha yoga on mantra meditation using a single-case multiple-baseline design. This study was part of a project evaluating the new mind-body program Meditation-Based Lifestyle Modification. Fifty-seven healthy participants with no regular yoga or meditation practice were randomly assigned to three baselines (7, 14, and 21 days) and four conditions using a random number generator. The conditions were mantra meditation alone (MA), meditation plus physical yoga (MY), meditation plus ethical education (ME), and meditation plus yoga and ethical education (MYE). All the interventions lasted for 8 weeks and were run consecutively according to baseline length. During the baseline and treatment phases, participants received daily questionnaires measuring their well-being (WHO-5 Well-Being Index), stress (Perceived Stress Scale), and subjective experiences. Forty-two participants completed the treatment and were entered in the analyses. We analyzed our data using visual inspection, effect size estimation (Tau-U), and multilevel modeling. Almost all participants showed a longitudinal increase in well-being. Regarding between-group differences, participants who received ethical education exhibited the largest increases in well-being (Tau-U = 0.30/0.23 for ME/MYE), followed by participants in the MY condition (Tau-U = 0.12). Conversely, participants in the MA condition showed no change (Tau-U = 0.07). There was a tendency for the combined treatments to decrease stress. This tendency was strongest in the MY condition (Tau-U = -0.40) and reversed in the MA condition (Tau-U = 0.17). These results emphasize the incremental and differential effects of practicing meditation in combination with other practices from the eight-fold yoga path. This approach is valuable for better understanding the multifaceted practice of yoga. Clinical Trial Registration:www.ClinicalTrials.gov, identifier: NCT04252976.

Dataset Information

Effects of yoga on well-being and healthy ageing: study protocol for a randomised controlled trial (FitForAge).

Introduction

Methods and analysis

Ethics and dissemination

Trial registration number

Publications

Effects of yoga on well-being and healthy ageing: study protocol for a randomised controlled trial (FitForAge).

Similar Datasets

OmicsDI is part of the ELIXIR infrastructure

Tweets