Clinical trial NCT03518723: Effect and Feasibility of Non-linear Periodized Resistance Training in People With COPD
Official title: Effect and Feasibility of Non-linear Periodized Resistance Training in People With Chronic Obstructive Pulmonary Disease: a Randomized Controlled Multicenter Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pulmonary Disease
Chronic Obstructive
Keywords: Muscle dysfunction
Lead sponsor: Umeå University
Sponsor class: OTHER
Collaborators: name: Centre de Recherche de l'Institut Universitaire de Cardiologie et de Pneumologie de Quebec
name: Radboud University Medical Center
name: Merem Pulmonary Rehabilitation Centre
First posted: 2018-05-08
Enrollment: 57
Sex: ALL
Minimum age (years): 40
Maximum age (years): 89
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Prospective, assessor-blind, parallel-group randomized controlled multicenter trial with a pre- and post-intervention design
Primary purpose: TREATMENT

Brief 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.


Eligibility criteria: 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

Primary outcomes:
measure: Change from baseline dynamic maximal endurance at week 9
timeFrame: Baseline and week 9
measure: Change from baseline dynamic maximal strength at week 9
timeFrame: Baseline and week 9
Secondary outcomes:
measure: Change from baseline static maximal endurance at week 9
timeFrame: Baseline and week 9
measure: Change from baseline static maximal strength at week 9
timeFrame: Baseline and week 9
measure: Change from baseline unsupported upper limb test (UULEX) at week 9
timeFrame: Baseline and week 9
measure: Change from baseline endurance shuttle walk test (ESWT) at week 9
timeFrame: Baseline and week 9
measure: Change from baseline 60 seconds sit to stand test (60STS) at week 9
timeFrame: Baseline and week 9
measure: Change From Baseline Chronic Respiratory Questionnaire Self-Administered Standardized Format (CRQ-SAS) Total Scores at week 9
timeFrame: Baseline and week 9
measure: Change From Baseline Chronic Respiratory Questionnaire Self-Administered Standardized Format (CRQ-SAS) dyspnea Domain Scores at week 9
timeFrame: Baseline and week 9
measure: Number of responders
timeFrame: Week 9
measure: Attendance rate
timeFrame: Week 1 up to 8
measure: Duration of exercise sessions
timeFrame: Week 1 up to 8
measure: Satisfaction rate
timeFrame: Week 9
measure: Proportion of drop-outs
timeFrame: Week 9
measure: Adverse Events rate
timeFrame: Week 1 up to 8
measure: Adverse Events stratified by severity
timeFrame: Week 1 up to 8
measure: Change from baseline muscle fiber size at week 9
timeFrame: Baseline and week 9
measure: Change from baseline proportion of slow and fast subtypes of contractile myosin heavy chain isoforms in fibers at week 9
timeFrame: Baseline and week 9
measure: Change from baseline oxidative (citrate synthase (CS), EC 4.1.3.7) enzyme activities at week 9
timeFrame: Baseline and week 9
measure: Change from baseline glycolytic (lactate dehydrogenase (LDH), EC 1.1.1.27) enzyme activities at week 9
timeFrame: Baseline and week 9
measure: Change from baseline capillarization (capillary density) at week 9
timeFrame: Baseline and week 9
measure: Change from baseline capillarization (capillaries to fiber) at week 9
timeFrame: Baseline and week 9
measure: Change from baseline capillarization (capillaries relative to fiber area) at week 9
timeFrame: Baseline and week 9
Other outcomes:
Locations:
city: Québec City
country: Canada
facility: Centre de Recherche de l'Institut Universitaire de Cardiologie et de Pneumologie de Quebec
city: Hilversum
country: Netherlands
facility: Merem Pulmonary Rehabilitation Centre
city: Umeå
country: Sweden
facility: Umeå University
Study officials:
affiliation: Umeå University
name: Andre Nyberg, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Frykholm E, Klijn P, Saey D, van Hees HWH, Stal P, Sandstrom T, Sorlin A, Maltais F, Nyberg A. Effect and feasibility of non-linear periodized resistance training in people with COPD: study protocol for a randomized controlled trial. Trials. 2019 Jan 3;20(1):6. doi: 10.1186/s13063-018-3129-y.