AzTrials
AzTrials

Pulmonary DiseaseNCT03518723

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

A study testing Non-linear Periodized Resistance Training and Resistance training in people with Pulmonary Disease and Chronic Obstructive, run by Umeå University at 3 sites in 3 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

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. Read more about this study

Who is it for?
Ages 40 to 89 years
Conditions the study is for
Pulmonary Disease, Chronic Obstructive
What is being tested?
Non-linear Periodized Resistance Training and Resistance training
Could I receive a placebo?
No, everyone receives an active treatment
How many people
57 participants
Where
3 sitesin 3 countries
Study dates
16 Apr 2018to 1 Mar 2023
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 40 to 89 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

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

Who cannot join

  • 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

Trial locations and contacts

3 sites in 3 countries.

3 sites in 3 countries

Canada1 site
  • Centre de Recherche de l'Institut Universitaire de Cardiologie et de Pneumologie de Quebec

    Québec

Other trials in Canada

Netherlands1 site
  • Merem Pulmonary Rehabilitation Centre

    Hilversum

Other trials in Netherlands

Sweden1 site
  • Umeå University

    Umeå

Other trials in Sweden

About this study

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

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.

Being tested
Non-linear Periodized Resistance Training, Resistance training
Keywords
Muscle dysfunction
Medical subject headings
Lung Diseases

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Non-linear Periodized Resistance TrainingOther

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

  • Resistance trainingOther

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

Study groups in NCT03518723
Study groupRoleWhat they receive
Non-linear Periodized Resistance TrainingExperimentalThe 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.
Receives: Other: Non-linear Periodized Resistance Training
Resistance TrainingActive comparatorThe 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.
Receives: Other: Resistance training

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: Baseline and week 9

  2. 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.

    Measured: Baseline and week 9

Secondary outcomes (21)
  1. 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.

    Measured: Baseline and week 9

  2. Change from baseline static maximal strength at week 9

    Maximal limb muscle strength measured using a computerized dynamometer or strain gauge. Reported in Nm

    Measured: Baseline and week 9

  3. 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.

    Measured: Baseline and week 9

  4. 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.

    Measured: Baseline and week 9

  5. 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.

    Measured: Baseline and week 9

  6. 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).

    Measured: Baseline and week 9

  7. 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).

    Measured: Baseline and week 9

  8. 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.

    Measured: Week 9

  9. Attendance rate

    Attendance rate will be evaluated by calculating the number of attended sessions divided by total number of sessions for each participant

    Measured: Week 1 up to 8

  10. Duration of exercise sessions

    Mean time in minutes of exercise sessions

    Measured: Week 1 up to 8

  11. 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).

    Measured: Week 9

  12. Proportion of drop-outs

    Proportion of participants that don't complete the intervention

    Measured: Week 9

  13. 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.

    Measured: Week 1 up to 8

  14. 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.

    Measured: Week 1 up to 8

  15. 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.

    Measured: Baseline and week 9

  16. 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.

    Measured: Baseline and week 9

  17. 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.

    Measured: Baseline and week 9

  18. 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.

    Measured: Baseline and week 9

  19. 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.

    Measured: Baseline and week 9

  20. 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.

    Measured: Baseline and week 9

  21. 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.

    Measured: Baseline and week 9

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted8 May 2018
  2. Study start16 Apr 2018
  3. Primary completion1 Mar 2023
  4. Study completion1 Mar 2023

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
Prospective, assessor-blind, parallel-group randomized controlled multicenter trial with a pre- and post-intervention design
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
57 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03518723
Sponsor's protocol ID
NLPRT-RCT
Status last verified
May 2024
First submitted
13 Apr 2018
Last updated
14 May 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 30606240

Questions about this trial

What is this clinical trial studying?

A study testing Non-linear Periodized Resistance Training and Resistance training in people with Pulmonary Disease and Chronic Obstructive, run by Umeå University at 3 sites in 3 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 14 May 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in Canada, Netherlands, Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change from baseline dynamic maximal endurance at week 9 (time frame: Baseline and week 9). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03518723, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 May 2024.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in