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

NCT ID: NCT03518723

Last Updated: 2024-05-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

57 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-04-16

Study Completion Date

2023-03-01

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Pulmonary Disease Chronic Obstructive

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Prospective, assessor-blind, parallel-group randomized controlled multicenter trial with a pre- and post-intervention design
Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors
The outcome assessors will be masked to group allocation. The participants will be given repeated instructions not to reveal their group allocation to the outcome assessors. In case of failure in keeping the outcome assessor masked (i.e, a patient reveals his/her group allocation), a second trained outcome assessor will be available.

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Non-linear Periodized Resistance Training

The objective of the Non-linear Periodized Resistance Training (NLPRT) program is to increase muscle strength as well as muscle endurance. The NLPRT program will over the 8 week intervention period target several different aspects of limb muscle function, by alternating the intensity and volume of the exercises.

Progression of exercise is symptom dependent and will be based on Borg CR-10 ratings (dyspnea, muscle fatigue and exertion).

All exercises will be performed using exercise equipment that are available at each included center.

All sessions are supervised and conducted by local professionals using a group format, with approximately 2-4 participants per group.

Group Type EXPERIMENTAL

Non-linear Periodized Resistance Training

Intervention Type OTHER

8 week non-linear periodized resistance training intervention, 3 sessions per week, 60 minutes per session

Resistance Training

The primary objective of the Resistance training (RT) group is to increase muscular strength. The RT program will be performed in line with current guidelines that are recommended for increasing muscular strength in patients with COPD.

Progression of exercise is performance dependent and will be based on the previous 2 sessions.

All exercises will be performed using exercise equipment that are available at each included center.

All sessions are supervised and conducted by local professionals using a group format, with approximately 2-4 participants per group.

Group Type ACTIVE_COMPARATOR

Resistance training

Intervention Type OTHER

8 week resistance training intervention, 3 sessions per week, 60 minutes per session

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Non-linear Periodized Resistance Training

8 week non-linear periodized resistance training intervention, 3 sessions per week, 60 minutes per session

Intervention Type OTHER

Resistance training

8 week resistance training intervention, 3 sessions per week, 60 minutes per session

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

40 Years

Maximum Eligible Age

89 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Centre de Recherche de l'Institut Universitaire de Cardiologie et de Pneumologie de Quebec

OTHER

Sponsor Role collaborator

Radboud University Medical Center

OTHER

Sponsor Role collaborator

Merem Pulmonary Rehabilitation Centre

UNKNOWN

Sponsor Role collaborator

Umeå University

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Andre Nyberg, PhD

Role: PRINCIPAL_INVESTIGATOR

Umeå University

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Centre de Recherche de l'Institut Universitaire de Cardiologie et de Pneumologie de Quebec

Québec, , Canada

Site Status

Merem Pulmonary Rehabilitation Centre

Hilversum, , Netherlands

Site Status

Umeå University

Umeå, , Sweden

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Canada Netherlands Sweden

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type DERIVED
PMID: 30606240 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

NLPRT-RCT

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.