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.
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
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.
- Conditions
- Pulmonary Disease, Chronic Obstructive
- 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 group | Role | What they receive |
|---|---|---|
| Non-linear Periodized Resistance Training | Experimental | 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. Receives: Other: Non-linear Periodized Resistance Training |
| Resistance Training | Active comparator | 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. Receives: Other: Resistance training |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
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)
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
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
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
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
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
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
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
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
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
Duration of exercise sessions
Mean time in minutes of exercise sessions
Measured: Week 1 up to 8
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
Proportion of drop-outs
Proportion of participants that don't complete the intervention
Measured: Week 9
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
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
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
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
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
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
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
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
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.
- First posted8 May 2018
- Study start16 Apr 2018
- Primary completion1 Mar 2023
- Study completion1 Mar 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Pulmonary DiseaseStudies of the same condition, open and under way.
- More trials run by Umeå UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- Umeå University
- Sponsor type
- University, hospital or other
- Collaborators
- Centre de Recherche de l'Institut Universitaire de Cardiologie et de Pneumologie de Quebec, Radboud University Medical Center, Merem Pulmonary Rehabilitation Centre
- Responsible party
- Sponsor
- Investigators
- Andre Nyberg, PhD, Principal investigator, Umeå University
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
Study at a glance
From the registry record, last updated by the sponsor on 14 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect and Feasibility of Non-linear Periodized Resistance Training in People With Chronic Obstructive Pulmonary Disease: a Randomized Controlled Multicenter Trial
- ClinicalTrials.gov ID
- NCT03518723
- Acronym / sponsor ID
- NLPRT-RCT
- Conditions
- Pulmonary Disease, Chronic Obstructive
- Keywords
- Muscle dysfunction
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 57 participants (actual)
- Lead sponsor
- Umeå UniversityUniversity, hospital or other
- Collaborators
- Centre de Recherche de l'Institut Universitaire de Cardiologie et de Pneumologie de Quebec, Radboud University Medical Center, Merem Pulmonary Rehabilitation Centre
- Study start
- 16 Apr 2018 (actual)
- Primary completion
- 1 Mar 2023 (actual)
- Study completion
- 1 Mar 2023 (actual)
- First posted
- 8 May 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Prospective, assessor-blind, parallel-group randomized controlled multicenter trial with a pre- and post-intervention design
| Arm | Type | Receives |
|---|---|---|
| Non-linear Periodized Resistance Training | Experimental | Other: Non-linear Periodized Resistance TrainingThe 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. |
| Resistance Training | Active comparator | Other: Resistance trainingThe 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. |
Who may qualify
- Ages
- 40 to 89 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- FEV1/FVC ratio < 70% postbronchodilator
- FEV1 <80% of the predicted normal value postbronchodilator
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Non-linear Periodized Resistance Training8 week non-linear periodized resistance training intervention, 3 sessions per week, 60 minutes per session | Other | Non-linear Periodized Resistance Training |
| Resistance training8 week resistance training intervention, 3 sessions per week, 60 minutes per session | Other | Resistance Training |
Primary outcome
Change from baseline dynamic maximal endurance at week 9
Time frame: Baseline and 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.
Change from baseline dynamic maximal strength at week 9
Time frame: Baseline and week 9
Maximal limb muscle strength measured using resistance training machines or free weights. Reported as one repetition max in kg.
21 secondary outcomes
Change from baseline static maximal endurance at week 9
Time frame: Baseline and week 9
Change from baseline static maximal strength at week 9
Time frame: Baseline and week 9
Change from baseline unsupported upper limb test (UULEX) at week 9
Time frame: Baseline and week 9
Change from baseline endurance shuttle walk test (ESWT) at week 9
Time frame: Baseline and week 9
Change from baseline 60 seconds sit to stand test (60STS) at week 9
Time frame: Baseline and week 9
Change From Baseline Chronic Respiratory Questionnaire Self-Administered Standardized Format (CRQ-SAS) Total Scores at week 9
Time frame: Baseline and week 9
Change From Baseline Chronic Respiratory Questionnaire Self-Administered Standardized Format (CRQ-SAS) dyspnea Domain Scores at week 9
Time frame: Baseline and week 9
Number of responders
Time frame: Week 9
Attendance rate
Time frame: Week 1 up to 8
Duration of exercise sessions
Time frame: Week 1 up to 8
Satisfaction rate
Time frame: Week 9
Proportion of drop-outs
Time frame: Week 9
Adverse Events rate
Time frame: Week 1 up to 8
Adverse Events stratified by severity
Time frame: Week 1 up to 8
Change from baseline muscle fiber size at week 9
Time frame: Baseline and week 9
Change from baseline proportion of slow and fast subtypes of contractile myosin heavy chain isoforms in fibers at week 9
Time frame: Baseline and week 9
Change from baseline oxidative (citrate synthase (CS), EC 4.1.3.7) enzyme activities at week 9
Time frame: Baseline and week 9
Change from baseline glycolytic (lactate dehydrogenase (LDH), EC 1.1.1.27) enzyme activities at week 9
Time frame: Baseline and week 9
Change from baseline capillarization (capillary density) at week 9
Time frame: Baseline and week 9
Change from baseline capillarization (capillaries to fiber) at week 9
Time frame: Baseline and week 9
Change from baseline capillarization (capillaries relative to fiber area) at week 9
Time frame: Baseline and week 9
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 May 2024.
- Derived from this study: PubMed 30606240Frykholm 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Andre Nyberg, PhD principal investigator
Umeå University
3 sites in 3 countries: see every site and its status.
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.