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Long-term Exercise After Pulmonary Rehabilitation (LEAP): Design and rationale of a randomized controlled trial of Tai Chi.

ABSTRACT: Persons with chronic obstructive pulmonary disease (COPD) have reduced exercise capacity and levels of physical activity. Supervised, facility-based pulmonary rehabilitation programs improve exercise capacity and reduce dyspnea, but novel long-term strategies are needed to maintain the benefits gained. Mind-body modalities such as Tai Chi which combine aerobic activity, coordination of breathing, and cognitive techniques that alleviate the physical inactivity, dyspnea, and anxiety and depression that are the hallmarks of COPD are promising strategies.We have designed a randomized controlled study to examine whether Tai Chi will maintain exercise capacity in persons with COPD who have recently completed a supervised pulmonary rehabilitation program, compared to standard care. The primary outcome is 6-min walk test distance at 6 months. Secondary outcomes include health-related quality of life, dyspnea, mood, occurrence of acute exacerbations, engagement in physical activity, exercise self-efficacy, and exercise adherence. Simultaneously, we are conducting a pilot study of group walking. We will enroll 90 persons who will be randomized to one of three arms in a 2:2:1 ratio: Tai Chi, standard care, or group-based walking.The Long-term Exercise After Pulmonary Rehabilitation (LEAP) study is a novel and clinically relevant trial. We will enroll a well-characterized cohort of persons with COPD and will comprehensively assess physiological and psychosocial outcomes. Results of this study will provide the evidence base for persons with COPD to engage in Tai Chi as a low-cost, long-term modality to sustain physical activity in persons who have completed a standard short-term pulmonary rehabilitation program.This trial is registered in Clinical Trials.gov, with the ID number of NCT01998724.

SUBMITTER: Moy ML

PROVIDER: S-EPMC4886504 | biostudies-literature | 2015 Nov

REPOSITORIES: biostudies-literature

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Long-term Exercise After Pulmonary Rehabilitation (LEAP): Design and rationale of a randomized controlled trial of Tai Chi.

Moy Marilyn L ML Wayne Peter M PM Litrownik Daniel D Beach Douglas D Klings Elizabeth S ES Davis Roger B RB Yeh Gloria Y GY

Contemporary clinical trials 20150908 Pt B

<h4>Background</h4>Persons with chronic obstructive pulmonary disease (COPD) have reduced exercise capacity and levels of physical activity. Supervised, facility-based pulmonary rehabilitation programs improve exercise capacity and reduce dyspnea, but novel long-term strategies are needed to maintain the benefits gained. Mind-body modalities such as Tai Chi which combine aerobic activity, coordination of breathing, and cognitive techniques that alleviate the physical inactivity, dyspnea, and anx ...[more]

PMID: 26362690

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Project description:Post-menopausal osteopenic women are at increased risk for skeletal fractures. Current osteopenia treatment guidelines include exercise, however, optimal exercise regimens for attenuating bone mineral density (BMD) loss, or for addressing other fracture-related risk factors (e.g. poor balance, decreased muscle strength) are not well-defined. Tai Chi is an increasingly popular weight bearing mind-body exercise that has been reported to positively impact BMD dynamics and improve postural control, however, current evidence is inconclusive. This study will determine the effectiveness of Tai Chi in reducing rates of bone turnover in post-menopausal osteopenic women, compared with standard care, and will preliminarily explore biomechanical processes that might inform how Tai Chi impacts BMD and associated fracture risks.A total of 86 post-menopausal women, aged 45-70y, T-score of the hip and/or spine -1.0 and -2.5, have been recruited from primary care clinics of a large healthcare system based in Boston. They have been randomized to a group-based 9-month Tai Chi program plus standard care or to standard care only. A unique aspect of this trial is its pragmatic design, which allows participants randomized to Tai Chi to choose from a pre-screened list of community-based Tai Chi programs. Interviewers masked to participants' treatment group assess outcomes at baseline and 3 and 9 months after randomization. Primary outcomes are serum markers of bone resorption (C-terminal cross linking telopeptide of type I collagen), bone formation (osteocalcin), and BMD of the lumbar spine and proximal femur (dual-energy X-ray absorptiometry). Secondary outcomes include health-related quality-of-life, exercise behavior, and psychological well-being. In addition, kinetic and kinematic characterization of gait, standing, and rising from a chair are assessed in subset of participants (n = 16) to explore the feasibility of modeling skeletal mechanical loads and postural control as mediators of fracture risk.Results of this study will provide preliminary evidence regarding the value of Tai Chi as an intervention for decreasing fracture risk in osteopenic women. They will also inform the feasibility, value and potential limitations related to the use of pragmatic designs for the study of Tai Chi and related mind-body exercise. If the results are positive, this will help focus future, more in-depth, research on the most promising potential mechanisms of action identified by this study.This trial is registered in ClinicalTrials.gov, with the ID number of NCT01039012.

Project description:ObjectivesThis systematic review aims to summarize the existing literature on Tai Chi randomized controlled trials (RCTs) and recommend Tai Chi exercise prescriptions for different diseases and populations.MethodsA systematic search for Tai Chi RCTs was conducted in five electronic databases (PubMed, Cochrane Library, EMBASE, EBSCO, and Web of Science) from their inception to December 2019. SPSS 20.0 software and Microsoft Excel 2019 were used to analyze the data, and the risk of bias tool in the RevMan 5.3.5 software was used to evaluate the methodological quality of RCTs.ResultsA total of 139 articles were identified, including diseased populations (95, 68.3%) and healthy populations (44, 31.7%). The diseased populations included the following 10 disease types: musculoskeletal system or connective tissue diseases (34.7%), circulatory system diseases (23.2%), mental and behavioral disorders (12.6%), nervous system diseases (11.6%), respiratory system diseases (6.3%), endocrine, nutritional or metabolic diseases (5.3%), neoplasms (3.2%), injury, poisoning and certain other consequences of external causes (1.1%), genitourinary system diseases (1.1%), and diseases of the eye and adnexa (1.1%). Tai Chi exercise prescription was generally classified as moderate intensity. The most commonly applied Tai Chi style was Yang style (92, 66.2%), and the most frequently specified Tai Chi form was simplified 24-form Tai Chi (43, 30.9%). 12 weeks and 24 weeks, 2-3 times a week, and 60 min each time was the most commonly used cycle, frequency, and time of exercise in Tai Chi exercise prescriptions.ConclusionsWe recommend the more commonly used Tai Chi exercise prescriptions for different diseases and populations based on clinical evidence of Tai Chi. Further clinical research on Tai Chi should be combined with principles of exercise prescription to conduct large-sample epidemiological studies and long-term prospective follow-up studies to provide more substantive clinical evidence for Tai Chi exercise prescriptions.

Project description:Knee Osteoarthritis (KOA) is a major cause of pain and functional impairment among elders. Currently, there are neither feasible preventive intervention strategies nor effective medical remedies for the management of KOA. Tai Chi, an ancient Chinese mind-body exercise that is reported to enhance muscle function, balance and flexibility, and to reduce pain, depression and anxiety, may safely and effectively be used to treat KOA. However, current evidence is inconclusive. Our study examines the effects of a 12-week Tai Chi program compared with an attention control (wellness education and stretching) on pain, functional capacity, psychosocial variables, joint proprioception and health status in elderly people with KOA. The study will be completed by July 2009.Forty eligible patients, age > 55 yr, BMI < or = 40 kg/m2 with tibiofemoral osteoarthritis (American College of Rheumatology criteria) are identified and randomly allocated to either Tai Chi (10 modified forms from classical Yang style Tai Chi) or attention control (wellness education and stretching). The 60-minute intervention sessions take place twice weekly for 12 weeks. The study is conducted at an urban tertiary medical center in Boston, Massachusetts. The primary outcome measure is the Western Ontario and McMaster Universities (WOMAC) pain subscale at 12 weeks. Secondary outcomes include weekly WOMAC pain, function and stiffness scores, patient and physician global assessments, lower-extremity function, knee proprioception, depression, self-efficacy, social support, health-related quality of life, adherence and occurrence of adverse events after 12, 24 and 48 weeks.In this article, we present the challenges of designing a randomized controlled trial with long-term follow up. The challenges encountered in this design are: strategies for recruitment, avoidance of selection bias, the actual practice of Tai Chi, and the maximization of adherence/follow-up while conducting the clinical trial for the evaluation of the effectiveness of Tai Chi on KOA.ClinicalTrials.gov identifier: NCT00362453.

Project description:BackgroundTai Chi has been shown to improve motor symptoms in Parkinson's disease (PD), but its long-term effects and the related mechanisms remain to be elucidated. In this study, we investigated the effects of long-term Tai Chi training on motor symptoms in PD and the underlying mechanisms.MethodsNinety-five early-stage PD patients were enrolled and randomly divided into Tai Chi (n = 32), brisk walking (n = 31) and no-exercise (n = 32) groups. At baseline, 6 months and 12 months during one-year intervention, all participants underwent motor symptom evaluation by Berg balance scale (BBS), Unified PD rating-scale (UPDRS), Timed Up and Go test (TUG) and 3D gait analysis, functional magnetic resonance imaging (fMRI), plasma cytokine and metabolomics analysis, and blood Huntingtin interaction protein 2 (HIP2) mRNA level analysis. Longitudinal self-changes were calculated using repeated measures ANOVA. GEE (generalized estimating equations) was used to assess factors associated with the longitudinal data of rating scales. Switch rates were used for fMRI analysis. False discovery rate correction was used for multiple correction.ResultsParticipants in the Tai Chi group had better performance in BBS, UPDRS, TUG and step width. Besides, Tai Chi was advantageous over brisk walking in improving BBS and step width. The improved BBS was correlated with enhanced visual network function and downregulation of interleukin-1β. The improvements in UPDRS were associated with enhanced default mode network function, decreased L-malic acid and 3-phosphoglyceric acid, and increased adenosine and HIP2 mRNA levels. In addition, arginine biosynthesis, urea cycle, tricarboxylic acid cycle and beta oxidation of very-long-chain fatty acids were also improved by Tai Chi training.ConclusionsLong-term Tai Chi training improves motor function, especially gait and balance, in PD. The underlying mechanisms may include enhanced brain network function, reduced inflammation, improved amino acid metabolism, energy metabolism and neurotransmitter metabolism, and decreased vulnerability to dopaminergic degeneration. Trial registration This study has been registered at Chinese Clinical Trial Registry (Registration number: ChiCTR2000036036; Registration date: August 22, 2020).

Project description:BACKGROUND:Knee osteoarthritis (OA) causes pain and long-term disability with annual healthcare costs exceeding $185 billion in the United States. Few medical remedies effectively influence the course of the disease. Finding effective treatments to maintain function and quality of life in patients with knee OA is one of the national priorities identified by the Institute of Medicine. We are currently conducting the first comparative effectiveness and cost-effectiveness randomized trial of Tai Chi versus a physical-therapy regimen in a sample of patients with symptomatic and radiographically confirmed knee OA. This article describes the design and conduct of this trial. METHODS/DESIGN:A single-center, 52-week, comparative effectiveness randomized controlled trial of Tai Chi versus a standardized physical-therapy regimen is being conducted at an urban tertiary medical center in Boston, Massachusetts. The study population consists of adults???40 years of age with symptomatic and radiographic knee OA (American College of Rheumatology criteria). Participants are randomly allocated to either 12 weeks of Tai Chi (2x/week) or Physical Therapy (2x/week for 6 weeks, followed by 6 weeks of rigorously monitored home exercise). The primary outcome measure is pain (Western Ontario and McMaster Universities WOMAC) subscale at 12 weeks. Secondary outcomes include WOMAC stkiffness and function domain scores, lower extremity strength and power, functional balance, physical performance tests, psychological and psychosocial functioning, durability effects, health related quality of life, and healthcare utilization at 12, 24 and 52 weeks. DISCUSSION:This study will be the first randomized comparative-effectiveness and cost-effectiveness trial of Tai Chi versus Physical Therapy in a large symptomatic knee OA population with long-term follow up. We present here a robust and well-designed randomized comparative-effectiveness trial that also explores multiple outcomes to elucidate the potential mechanisms of mind-body effect for a major disabling disease with substantial health burdens and economic costs. Results of this study are expected to have important public health implications for the large and growing population with knee OA. TRIAL REGISTRATION:ClinicalTrials.gov identifier: NCT01258985.

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Long-term Exercise After Pulmonary Rehabilitation (LEAP): Design and rationale of a randomized controlled trial of Tai Chi.

Publications

Long-term Exercise After Pulmonary Rehabilitation (LEAP): Design and rationale of a randomized controlled trial of Tai Chi.

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