Effect and Feasibility of Non-linear Periodized Resistance Training in People With COPD

Pulmonary Disease Clinical Trial

Official title:

Effect and Feasibility of Non-linear Periodized Resistance Training in People With Chronic Obstructive Pulmonary Disease: a Randomized Controlled Multicenter Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03518723
• Other study ID #: NLPRT-RCT
• Status: Recruiting
• Phase: N/A
• Start date: April 16, 2018
• Est. completion date: December 2022

Study information

• Verified date: November 2022
• Source: Umeå University
• Contact: Andre Nyberg, PhD
• Phone: +46(0)907866639
• Email: andre.nyberg[@]umu.se
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study aims at improving the knowledge about resistance training for people with COPD. Resistance training is an important part of pulmonary rehabilitation when the goal is to improve muscular endurance and strength. The study will evaluate the effects and the feasibility of two resistance training programs for people with COPD using a parallel group design. One program will include a larger day-to-day variation (i.e. non-linear periodization) and the progression will be guided by ratings of dyspnea, muscle fatigue, and exertion. The other program will follow the established guidelines for resistance training for people with COPD. The programs will be evaluated for effects regarding muscular endurance, strength, intramuscular adaptions, functional preformance, dyspnea, and health related quality of life. The programs will also be evaluated for feasibility regarding the duration of training sessions, attendance rates, adverse events, and participant satisfaction. The hypothesis is that the non-linear periodization group will have superior effects and that feasibility aspects will be similar between groups.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 64
• Est. completion date: December 2022
• Est. primary completion date: December 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years to 89 Years

Eligibility

Inclusion Criteria:

• FEV1/FVC ratio < 70% postbronchodilator
• FEV1 <80% of the predicted normal value postbronchodilator

Exclusion Criteria:

• Clinical evidence of asthma, cardiovascular diseases, and/or neuromuscular diseases that are unstable and/or that may contribute to exercise limitation
• Other contraindications to exercise
• Currently participating in a structured exercise or pulmonary rehabilitation program or been involved in pulmonary rehabilitation in the past 6 months
• Experienced a COPD exacerbation and/or change in medication dosage/frequency in the past 6 weeks

Related Conditions & MeSH terms

• Chronic Obstructive
• Lung Diseases
• Pulmonary Disease

Intervention

Other:
• Non-linear Periodized Resistance Training
8 week non-linear periodized resistance training intervention, 3 sessions per week, 60 minutes per session
• Resistance training
8 week resistance training intervention, 3 sessions per week, 60 minutes per session

Locations

Country	Name	City	State
Canada	Centre de Recherche de l'Institut Universitaire de Cardiologie et de Pneumologie de Quebec	Québec City
Netherlands	Merem Pulmonary Rehabilitation Centre	Hilversum
Netherlands	Radboud UMC	Nijmegen
Sweden	Umeå University	Umeå

Sponsors (4)

Lead Sponsor	Collaborator
Umeå University	Centre de Recherche de l'Institut Universitaire de Cardiologie et de Pneumologie de Quebec, Merem Pulmonary Rehabilitation Centre, Radboud University Medical Center

Countries where clinical trial is conducted

Canada,  Netherlands,  Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from baseline dynamic maximal endurance at week 9	Maximal limb muscle endurance measured using resistance training machines or free weights. Reported as the number of repetitions at 45% of the baseline one repetition maximum.	Baseline and week 9
Primary	Change from baseline dynamic maximal strength at week 9	Maximal limb muscle strength measured using resistance training machines or free weights. Reported as one repetition max in kg.	Baseline and week 9
Secondary	Change from baseline static maximal endurance at week 9	Maximal limb muscle endurance measured using a computerized dynamometer or strain gauge. Reported in seconds maintaining 60% of the isometric maximal voluntary contraction.	Baseline and week 9
Secondary	Change from baseline static maximal strength at week 9	Maximal limb muscle strength measured using a computerized dynamometer or strain gauge. Reported in Nm	Baseline and week 9
Secondary	Change from baseline unsupported upper limb test (UULEX) at week 9	The UULEX is a progressive test where the participants will be asked to a raise plastic bar from the hip to the UULEX eight-level chart with a cadence of 30 movements per minute. If a patient reaches the highest level, the plastic bar will be replaced by a heavier one every minute. There are five different bar weights (0.2, 0.5, 1, 1.5, 2 Kg) and participants will continue on the highest level until symptom limitation. Results are reported in seconds.	Baseline and week 9
Secondary	Change from baseline endurance shuttle walk test (ESWT) at week 9	The ESWT is a derivative of the Incremental shuttle walk test (ISWT), where patients walk for as long as possible at a predetermined percentage of maximum walking performance as assessed by the ISWT on a 10 meter course. Reported in seconds to termination of the test or total meters walked.	Baseline and week 9
Secondary	Change from baseline 60 seconds sit to stand test (60STS) at week 9	During the 60STS, participants will be instructed to fully stand up and sit down as fast as possible, as many times as possible within 60 seconds. Arms will be held fold across the chest with feet remaining in full contact with the floor. Reported as the number of repetitions performed within 60 seconds.	Baseline and week 9
Secondary	Change From Baseline Chronic Respiratory Questionnaire Self-Administered Standardized Format (CRQ-SAS) Total Scores at week 9	The CRQ-SAS is a self-administered questionnaire which consist of 20 items across four domains: dyspnea (5 items), fatigue (4 items), emotional function (7 items), and mastery (4 items). Participants rates their experience on a 7-point scale in response to each item ranging from 1 (maximum impairment) to 7 (no impairment). Individual items are equally weighted, and total score ranges from 20 to 140 (20 maximum impairment, 140 no impairment).	Baseline and week 9
Secondary	Change From Baseline Chronic Respiratory Questionnaire Self-Administered Standardized Format (CRQ-SAS) dyspnea Domain Scores at week 9	Domain scores are calculated as the mean of all items (5) within the dyspnea domain. Participants rates their experience on a 7-point scale in response to each item ranging from 1 (maximum impairment) to 7 (no impairment). Individual items are equally weighted, and total score ranges from 7 to 35 (7 maximum dyspnea, 35 no dyspnea).	Baseline and week 9
Secondary	Number of responders	The total amount of responders i.e. defined as a response over the known minimal detectable change/or minimal important difference for included test(s) will be determined and compared.	Week 9
Secondary	Attendance rate	Attendance rate will be evaluated by calculating the number of attended sessions divided by total number of sessions for each participant	Week 1 up to 8
Secondary	Duration of exercise sessions	Mean time in minutes of exercise sessions	Week 1 up to 8
Secondary	Satisfaction rate	Participant satisfaction with the exercise regimens will be recorded by adapting an existing patient satisfaction questionnaire. Participants rate their satisfaction on 7 items each with a 5 point likert scale. Results using the total score (0-35, higher score indicating higher satisfaction).	Week 9
Secondary	Proportion of drop-outs	Proportion of participants that don't complete the intervention	Week 9
Secondary	Adverse Events rate	Occurrence of any adverse events. An adverse event rate will be calculated for each patient as the total number of sessions during which any adverse events occurred divided by the total number of attended sessions.	Week 1 up to 8
Secondary	Adverse Events stratified by severity	The severity of the adverse events will be assessed and rated into four different categories: 1) minor and temporary, 2) serious symptoms (potential risk of severe injury or life threatening), 3) manifest injury or disease, and 4) death. Presented in factual numbers for each group.	Week 1 up to 8
Secondary	Change from baseline muscle fiber size at week 9	The tissue sample obtained from the vastus lateralis muscle will be examined with morphometric analyses to determine cross-sectional fiber area. Reported in square micrometers.	Baseline and week 9
Secondary	Change from baseline proportion of slow and fast subtypes of contractile myosin heavy chain isoforms in fibers at week 9	The tissue sample obtained from the vastus lateralis muscle will be examined with immunohistochemistry techniques to categorize fiber types.	Baseline and week 9
Secondary	Change from baseline oxidative (citrate synthase (CS), EC 4.1.3.7) enzyme activities at week 9	The tissue sample obtained from the vastus lateralis muscle will be examined to demonstrate enzyme activities. Reported in micromol/min/g tissue.; [Time Frame: Baseline and week 9] The tissue sample obtained from the vastus lateralis muscle will be examined by histochemistry to demonstrate enzyme activities. Reported in micromol/min/g tissue.	Baseline and week 9
Secondary	Change from baseline glycolytic (lactate dehydrogenase (LDH), EC 1.1.1.27) enzyme activities at week 9	The tissue sample obtained from the vastus lateralis muscle will be examined to demonstrate enzyme activities. Reported in micromol/min/g tissue.	Baseline and week 9
Secondary	Change from baseline capillarization (capillary density) at week 9	The tissue sample obtained from the vastus lateralis muscle will be examined with morphometric analysis to determine capillary density, estimated as the total number of capillaries per millimeter squared muscle cross-section.	Baseline and week 9
Secondary	Change from baseline capillarization (capillaries to fiber) at week 9	The tissue sample obtained from the vastus lateralis muscle will be examined with morphometric analysis to determine the number of capillaries around fibers including all capillaries in contact with each muscle fiber.	Baseline and week 9
Secondary	Change from baseline capillarization (capillaries relative to fiber area) at week 9	The tissue sample obtained from the vastus lateralis muscle will be examined with morphometric analysis to determine the number of capillaries around each fiber relative to its cross-sectional area.	Baseline and week 9