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Effect and feasibility of non-linear periodized resistance training in people with COPD: study protocol for a randomized controlled trial.

ABSTRACT: BACKGROUND:In people with chronic obstructive pulmonary disease (COPD), limb-muscle dysfunction is one of the most troublesome systemic manifestations of the disease, which at the functional level is evidenced by reduced strength and endurance of limb muscles. Improving limb-muscle function is an important therapeutic goal of COPD management, for which resistance training is recommended. However, current guidelines for resistance training in COPD mainly focus on improving muscle strength which only reflects one aspect of limb-muscle function and does not address the issue of reduced muscle endurance. The latter is of importance considering that the reduction in limb-muscle endurance often is greater than that of muscle weakness, and also, limb-muscle endurance seems to be closer related to walking capacity as well as arm function than to limb-muscle strength within this group of people. Thus, strategies targeting multiple aspects of the decreased muscle function are warranted to increase the possibility for an optimal effect for the individual patient. Periodized resistance training, which represents a planned variation of resistance training variables (i.e., volume, intensity, frequency, etc.), is one strategy that could be used to target limb-muscle strength as well as limb-muscle endurance within the same exercise regimen. METHODS:This is an international, multicenter, randomized controlled trial comparing the effect and feasibility of non-linear periodized resistance training to traditional non-periodized resistance training in people with COPD. Primary outcomes are dynamic limb-muscle strength and endurance. Secondary outcomes include static limb-muscle strength and endurance, functional performance, quality of life, dyspnea, intramuscular adaptations as well as the proportion of responders. Feasibility of the training programs will be assessed and compared on attendance rate, duration, satisfaction, drop-outs as well as occurrence and severity of any adverse events. DISCUSSION:The proposed trial will provide new knowledge to this research area by investigating and comparing the feasibility and effects of non-linear periodized resistance training compared to traditional non-periodized resistance training. If the former strategy produces larger physiological adaptations than non-periodized resistance training, this project may influence the prescription of resistance training in people with COPD. TRIAL REGISTRATION:ClinicalTrials.gov, ID: NCT03518723 . Registered on 13 April 2018.

SUBMITTER: Frykholm E

PROVIDER: S-EPMC6318913 | biostudies-literature | 2019 Jan

REPOSITORIES: biostudies-literature

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Effect and feasibility of non-linear periodized resistance training in people with COPD: study protocol for a randomized controlled trial.

Frykholm Erik E Klijn Peter P Saey Didier D van Hees Hieronymus W H HWH Stål Per P Sandström Thomas T Sörlin Ann A Maltais François F Nyberg André A

Trials 20190103 1

<h4>Background</h4>In people with chronic obstructive pulmonary disease (COPD), limb-muscle dysfunction is one of the most troublesome systemic manifestations of the disease, which at the functional level is evidenced by reduced strength and endurance of limb muscles. Improving limb-muscle function is an important therapeutic goal of COPD management, for which resistance training is recommended. However, current guidelines for resistance training in COPD mainly focus on improving muscle strength ...[more]

PMID: 30606240

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Project description:The literature discusses that combined training, aerobic more resistance exercises in the same session, is a suitable strategy for people with obesity and that exercise periodization leads to positive health outcomes; however, the implication of different periodizations of combined training for health outcomes in obese adults requires further investigation. The aim of the study will be to describe the methodology used to compare the effect of linear periodized and non-periodized combined training on health markers and health-related physical fitness in adults with obesity. This is a blinded randomized controlled clinical trial investigating adults with obesity in the age group 20-50 years. The sample will be non-probabilistic, and participants will be allocated randomly into one of three groups: control group (CG), non-periodized group (NG), and periodized group (PG). The intervention will occur in 60-min sessions, 3 days a week for 16 weeks, with 1 week dedicated to familiarization with the training and 15 weeks of combined training (aerobic followed by resistance in the same session). The PG group will perform three mesocycles of 5 weeks each, progressing in intensity throughout the intervention [aerobic: from 40-49% to 60-69% of heart rate reserve (HRR); strength: from 12 to 14 maximum repetitions (MR) to 8 to 10MR]; the NG group will maintain the same relative intensity throughout the study (aerobic: 50-59% of HRR; strength: 2 sets of 10-12 MR). Participants in the CG group will maintain their usual activities without the proposed intervention. Pre- and post-intervention assessments will be performed for biochemical markers, body composition, cardiovascular parameters, cardiorespiratory fitness, maximum upper and lower limb strength, flexibility, and subjective health-related parameters. This project was approved by the Committee of Ethics and Research with Human Beings of the institution of origin (protocol 2,448,674) and registered in the Brazilian Registry of Clinical Trials (RBR-3c7rt3).

Project description:The number of falls experienced by people with knee osteoarthritis (OA) is almost double the number experienced by people with no OA. The neuromuscular elements required to arrest a fall are more impaired in people with knee OA compared to their asymptomatic counterparts. Therefore, these elements may need to be incorporated into an exercise intervention to reduce the risk of falling. The aim of this study will be to examine the feasibility, safety and patient satisfaction of a high-speed resistance-training program, with and without balance exercises, in people with knee OA compared to a control group. The effect of these exercise programs on lower-limb muscle strength and physiological and functional risk factors for falls will also be examined.This study will be a pilot randomized controlled trial with a pre- and post-intervention design (outcome assessments at baseline and 8 weeks after participation commencement) comparing three groups: a control group (no intervention), a high-speed resistance-training group and a high-speed resistance-training plus balance exercises group. Thirty people with knee osteoarthritis aged 60-90 years will be recruited and randomized to one of the three groups. Feasibility and safety will be assessed by examining adherence to the exercise program, dropout rate, pain level during and following exercise, number of exercises stopped due to pain, and any adverse event or any incident that prevents the participant from completing the prescribed exercise. Secondary measures of lower-limb strength, physical function, self-reported pain and function, fear of falls, and executive function and quality of life will also be assessed. To determine statistical trends of effectiveness and hence to inform sample size for a fully powered study, analyses of the secondary outcomes will be performed to assess the changes within and between groups over time (pre-post) using repeated measure ANOVA.The results of this study will improve understanding of what type of exercise is safe and beneficial for people with knee OA to reduce their risk of falling, and hence will inform the development of a future large research trial.Australian New Zealand Clinical Trials Registry, ID: ACTRN12616001382460 . Registered on 6 October 2016.

Project description:BackgroundThis feasibility study is intended to assess the acceptability of home-based task-specific reach-to-grasp (RTG) training for people with stroke, and to gather data to inform recruitment, retention, and sample size for a definitive randomized controlled trial.Methods/designThis is to be a randomized controlled feasibility trial recruiting 50 individuals with upper-limb motor impairment after stroke. Participants will be recruited after discharge from hospital and up to 12 months post-stroke from hospital stroke services and community therapy-provider services. Participants will be assessed at baseline, and then electronically randomized and allocated to group by minimization, based on the time post-stroke and extent of upper-limb impairment. The intervention group will receive 14 training sessions, each 1 hour long, with a physiotherapist over 6 weeks and will be encouraged to practice independently for 1 hour/day to give a total of 56 hours of training time per participant. Participants allocated to the control group will receive arm therapy in accordance with usual care. Participants will be measured at 7 weeks post-randomization, and followed-up at 3 and 6 months post-randomization. Primary outcome measures for assessment of arm function are the Action Research Arm Test (ARAT) and Wolf Motor Function Test (WMFT). Secondary measures are the Motor Activity Log, Stroke Impact Scale, Carer Strain Index, and health and social care resource use. All assessments will be conducted by a trained assessor blinded to treatment allocation. Recruitment, adherence, withdrawals, adverse events (AEs), and completeness of data will be recorded and reported.DiscussionThis study will determine the acceptability of the intervention, the characteristics of the population recruited, recruitment and retention rates, descriptive statistics of outcomes, and incidence of AEs. It will provide the information needed for planning a definitive trial to test home-based RTG training.Trial registration isrctnISRCTN56716589.

Project description:BackgroundThe objective of this study is to analyze the influence of a 14-week periodized circuit training protocol on patients with knee osteoarthritis (OA), in randomized intervention groups, on thigh intermuscular adipose tissue (interMAT), body composition, systemic inflammation, cartilage degradation, and its repercussion on pain, functional performance and quality of life.MethodsThis study presents a protocol for a randomized controlled trial. Sixty selected participants diagnosed with knee OA grades II and III, 40-65 years old and BMI < 30 kg/m2, will be randomly divided into three groups:periodized circuit training, strength training, and educational protocol. The circuit training and strength training protocols consist of 14-week training protocols conducted 3 times a week. The circuit training group will perform selected exercises previously stratified as light, moderate, and intense, arranged progressively in a circuit model, the strength group will perform regular strength exercises, and the educational protocol group will participate in a 14-week protocol with lectures twice a month about healthy lifestyles. Baseline and follow-up evaluations will be conducted for thigh interMAT (computed tomography), body composition (DXA), inflammation (IL-1β, IL-6, IL-10, TNF-α, leptin, and adiponectin), and joint degradation biomarkers (uCTX-II and sCOMP), performance-based tests (30s Chair Stand Test, 40 m Fast-paced Walk Test and Stair Climb Test), quadriceps and hamstring maximal isometric voluntary contraction (MIVC), and questionnaires (WOMAC and pain catastrophizing scale). Repeated measures ANOVA will be used to compare differences between groups (circuit training X strength training X educational protocol) at the different times of assessment (baseline x follow-up or baseline x during protocol x follow-up) for each of the dependent variables. When significant main effects were found, the pots hoc Bonferroni test will be used to identify statistical differences. A significance level of 5% (p < 0.05) will be adopted.DiscussionThis will be the first randomized controlled trial to assess the effects of a circuit training protocol on patients with knee OA on thigh intermuscular adipose tissue (interMAT). Given the prevalence and impact of OA and the widespread availability of this intervention, assessing the efficacy of a low-cost, non-pharmacological, and non-invasive treatment for knee OA patients has the potential for immediate and high clinical impact.Trial registrationClinicalTrials.gov, NCT02761590 , registered in May 4, 2016.

Project description:Background People with mobility limitations can benefit from rehabilitation programs incorporating intensive, repetitive, and task-specific exercises using digital devices such as virtual reality gaming systems, tablet and smartphone applications, and wearable devices. The Activity and MObility UsiNg Technology (AMOUNT) rehabilitation trial (n = 300) showed improvements in mobility in people using these types of digital devices in addition to their usual rehabilitation care when the intervention was provided by an additional study-funded physiotherapist. However, it is not clear if this intervention can be implemented by hospital physiotherapists with a usual clinical load. The AMOUNT Implementation trial aims to explore the feasibility of conducting a large-scale implementation trial. Methods A pragmatic, assessor blinded, feasibility hybrid type II randomized controlled trial will be undertaken at a public hospital in Australia. There will be two phases. Phase I (Implementation phase) will involve implementing the digital devices into physiotherapy practice. Physiotherapists from the rehabilitation ward will receive a multifaceted implementation strategy guided by the Capabilities, Opportunities, Motivation-Behaviour (COM-B) theoretical model. The implementation strategy includes identifying and training a clinical champion; providing digital devices and education and training; facilitating use of the devices through clinical reasoning sessions and journal clubs; and audit and feedback of exercise dosage documentation. Phase II (Trial phase) will involve randomising 30 eligible inpatients from the same ward into either usual care or usual care plus an additional 30 min or more of exercises using digital devices. This intervention will be provided by the physiotherapists who took part in the implementation phase. We will collect data on feasibility, implementation, and patient-level clinical outcomes. The three primary outcome measures are the extent to which physiotherapists document the dosage of exercises provided to participants (feasibility criteria: exercise practice sheets complete for ≥85% of all participants); ability to recruit participants; and fidelity to the protocol of using digital devices to prescribe exercises (feasibility criteria: average of ≥ 30mins per day for > 50% intervention participants). Discussion This feasibility study will provide important information to guide the planning and conduct of a future large-scale implementation trial. Trial registration Australian and New Zealand Clinical Trial Registry; ACTRN12621000938808; registered 19/07/2021. Trial sponsor: Prince of Wales Hospital. 320–346 Barker Street, Randwick, NSW, 2031, Australia. Protocol version: 6.2 7th April 2021. Supplementary Information The online version contains supplementary material available at 10.1186/s40814-023-01298-y.

Project description:BackgroundRegular exercise is an effective method for reducing pain and disability in patients with knee osteoarthritis (OA), as well as improving body composition. Thus, a combination of both resistance and aerobic training (circuit training) has shown to be promising for this population. However, access to physical therapy is limited by physical distance, social isolation, and/or treatment costs. Remote rehabilitation seems to be an effective way to minimize these barriers, but the benefits are dependent on the participants' adherence to the interventions provided at a distance. The objectives of this protocol are to compare the effects of a periodized circuit training applied via telerehabilitation with the same protocol applied in the face-to-face model for individuals with knee OA.MethodsThis study presents a single-blinded protocol for a non-inferiority randomized controlled trial. One hundred participants diagnosed with knee OA (grades II and III Kellgren and Lawrence system), aged 40 years or more, and BMI < 30 kg/m2 will be randomly divided into two groups: telerehabilitation (TR) and face-to-face (FtF) circuit training. The FtF group will perform a 14-week periodized circuit training protocol supervised by a physical therapist, 3 times a week. The TR group will perform the same exercise protocol at home, at least 3 times a week. In addition, the TR group will be able to follow the execution and orientations of the exercises by DVD, a website, and online file sharing tools, and they will receive periodic phone calls in order to motivate, clarify, and inform some aspects of knee OA. The primary outcomes are changes in self-reported pain intensity (visual analog scale (VAS)) and physical function (Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)), with a primary end-point of 14 weeks and a secondary end-point of 26 weeks. Secondary outcomes include changes in other clinical outcomes, in morphological characteristics, adherence, acceptability, and treatment perspective.DiscussionA circuit training through telerehabilitation may contribute to developing early intervention in the causative and potentiating factors of the knee OA, verifying the effects of a low-cost, non-pharmacological and non-invasive treatment.Trial registrationBrazilian Registry of Clinical Trials (ReBEC) ID: RBR-662hn2. Registered on 31 March 2019. Link: http://www.ensaiosclinicos.gov.br ; Universal Trial Number (UTN) of World Health Organization: U1111-1230-9517.

Dataset Information

Effect and feasibility of non-linear periodized resistance training in people with COPD: study protocol for a randomized controlled trial.

Publications

Effect and feasibility of non-linear periodized resistance training in people with COPD: study protocol for a randomized controlled trial.

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