Chronic Obstructive Pulmonary DiseaseNCT05586399
The Effect of Maximal Strength Training on Lung Function in Patients With COPD
A study testing Maximal strength training in COPD in people with Chronic Obstructive Pulmonary Disease, run by Molde University College at 1 site in Norway.
Trial summary
The purpose of this study is to investigate the effect on maximal strength training on muscle function, lung function and quality of life for patients diagnosed with COPD grade II-III (Gold scale). Each patient will complete a total of 20 exercise session participating in a rehabilitation program for 4 weeks. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Obstructive Pulmonary Disease
- What is being tested?
- Maximal strength training in COPD
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteNorway
- Study dates
- 15 Nov 2022to 30 Jun 2024
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- COPD-diagnosis grade II-III (Gold Classification)
- Patients in one of two rehabilitation centres in Trondheim, Norway.
- Must be able to perform the test procedures walking or running on a treadmill.
- Must participate in at least 18 of the 20 planned training sessions.
Who cannot join
- Other pulmonary disease than COPD
- Diabetes mellitus or other metabolic diseases
- Use of corticosteroids the last 6 weeks
- Pulmonary infection the last 4 weeks
Trial locations and contacts
1 site in 1 country.
Jan Helgerud, PhD contact
Norway1 site
My Workout - Medical Rehabilitation Clinic
Trondheim, 7047
Norun Aagård, Msc, 47472788, norun.aagaard@treningsklinikken.no
Jan Hoff, PhD, janhoff@myworkout.no
About this study
The purpose of this study is to investigate the effect on maximal strength training on muscle function, lung function and quality of life for patients diagnosed with COPD grade II-III (Gold scale). Each patient will complete a total of 20 exercise session participating in a rehabilitation program for 4 weeks. Physiological and functional testing will be performed 4 weeks before the training intervention, at baseline and after the intervention period.
Read the detailed description
COPD is a group of diseases which affect the pulmonary system and leads to airflow restrictions and breathing difficulty. Other healthcare related problems, such as chronic inflammation, reduced muscle function, anxiety, depression and cardiovascular diseases are often seen in patients who are diagnosed with COPD.
Frequent participation in physical activity has been shown to improve the general public health, and serve as a prevention for development of various chronic diseases. Physical activity has at the same time been shown to be effective in treatment of both pulmonary and cardiovascular diseases. It also has the potential to reduce the need for health services, and can replace or reduce the need for medicinal treatments.
In this study we are want to investigate the effect of maximal strength training in COPD patients grade II-III on both muscle function and lung function. Maximal strength training (MST) have previously been shown as a superior intervention to achieve increased 1RM and fast development of power, also known as rate of force development (RFD). Lung function in COPD patients has been shown in previous research to be improved following maximal strength training.
The participants will partake in a total of 20 MST interventions during a rehabilitation period of 4 weeks. The sessions will be distributed five times a week located in two different Rehabilitation Centers in Trondheim, Norway. The strength training will be performed in groups, supervised by one or more coworkers in the project. MST will be performed with 4 series of 4 RM in a horizontal leg press machine, supervised by a coworker in the project. As part of the rehabilitation program, participants will also perform endurance training parallell to the MST sessions.
The participants will function as their own control group in the project. They will participate in a pre-test 4 weeks before the intervention period. After the pre-test they will be instructed to live as usual for the next 4 weeks. They will then start the intervention period, with tests performed at start and end of the period.
Both subjective and objective measurements will be performed 4 weeks before, at baseline and after the intervention period. All physiological tests will be completed during the same day. A standardized work economy test on a treadmill will be used in assessment of endurance capacity, with an expected duration of 4 minutes. The work economy test will be followed by a standardized graded test of maximal oxygen consumption, with a maximal duration of 10 minutes. Both endurance tests will be performed on a treadmill, with continuous heart rate monitoring. Approximately 5-10 minutes after finishing the endurance tests, a test of maximal dynamic strength will be performed (1RM test). The test will be performed in a horizontal leg press machine. After three submaximal warm-up sets, the load will be gradually increased until the participant fails to perform the test. Duration of rest periods between sets will be standardized to 3 minutes. Rate of force development will also be assessed, with the use of a force plate in the same horizontal leg press machine. There will also be performed functional tests (6 minute walk test, Timed Up and Go and stair climb test). All participants will also answer standardized questionnaires regarding health related quality of life.
- Conditions
- Chronic Obstructive Pulmonary Disease
- Being tested
- Maximal strength training in COPD
- Keywords
- Strength training, Lung function, Quality of life
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Maximal strength training in COPDBehavioural
Participate in a rehabilitation program for 4 weeks, with exercise 5 times a week. Supervised maximal strength training in a leg press machine for a total of 20 exercise sessions. Patients will participate in rehabilitation in one of two rehabilitations centers in Trondheim, Norway.
| Study group | Role | What they receive |
|---|---|---|
| Exercise intervention | Experimental | Participants performing a rehabilitation program for 5 times a week in a total of 4 weeks in one of two rehabilitation centers in Trondheim, Norway. The aim is to perform a total of 20 maximal strength training interventions supervised by one or more health professionals. Maximal strength training will be performed with 4 repetitions and 4 series at 90-95% of one repetition maximum. Receives: Behavioral: Maximal strength training in COPD |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Maximal Strenght
Measured in 1 repetition maximum (kg) in leg press.
Measured: 4 weeks before the intervention, at baseline and after 20 training sessions during 4 weeks weeks of rehabilitation.
Change in Rate of Force Development
Measured in Newton using a force plate
Measured: 4 weeks before the intervention, at baseline and after 20 training sessions during 4 weeks weeks of rehabilitation.
Change in Forced Expiratory Volume (FEV1)
Measured using spirometry as the maximal volume of air (liter) exhaled in the first second of expiration
Measured: 4 weeks before the intervention, at baseline and after 20 training sessions during 4 weeks weeks of rehabilitation.
Change in Peak Expiratory Flow (PEF)
Measured using spirometry as the maximal speed of expiration (Measured as liter/min)
Measured: 4 weeks before the intervention, at baseline and after 20 training sessions during 4 weeks weeks of rehabilitation.
Change in Work Economy
Measured using CPET walking on a treadmill at a standardized speed and incline (Measured as VO2 ml/kg/min)
Measured: 4 weeks before the intervention, at baseline and after 20 training sessions during 4 weeks weeks of rehabilitation.
Change in Maximal Oxygen Consumption
Measured using CPET in maximal test walking until exhaustion(Measured as VO2 ml/kg/min)
Measured: 4 weeks before the intervention, at baseline and after 20 training sessions during 4 weeks weeks of rehabilitation.
Change in Stair Climbing-test
Measured in seconds as the average of two attempts
Measured: 4 weeks before the intervention, at baseline and after 20 training sessions during 4 weeks weeks of rehabilitation.
Change in Timed up and Go-test
Measured in seconds as the average of two attempts
Measured: 4 weeks before the intervention, at baseline and after 20 training sessions during 4 weeks weeks of rehabilitation.
Change in 6 Minutes Walk Test
Measured in meters
Measured: 4 weeks before the intervention, at baseline and after 20 training sessions during 4 weeks weeks of rehabilitation.
Secondary outcomes (5)
Changes in health-related quality of life - Norwegian RAND36
Questionnaire scoring on a 0-100 scale with higher scores identifying better outcomes
Measured: 4 weeks before the intervention, at baseline and after 20 training sessions during 4 weeks weeks of rehabilitation.
Changes in health-related quality of life - Hospital and Anxiety Score (HADS)
Questionnaires - Change in total score from 0-21 where higher score may indicate anxiety and/or depression
Measured: 4 weeks before the intervention, at baseline and after 20 training sessions during 4 weeks weeks of rehabilitation.
Changes in health-related quality of life - International physical activity questionnaire (IPAQ)
Questionnaires - Change in MET-minutes of physical acitivity a week with higher score identifying better outcomes
Measured: 4 weeks before the intervention, at baseline and after 20 training sessions during 4 weeks weeks of rehabilitation.
Changes in health-related quality of life - EQ-5D-5L
Questionnaires - Change in health state from level 1-5 with lower level identifying better outcomes
Measured: 4 weeks before the intervention, at baseline and after 20 training sessions during 4 weeks weeks of rehabilitation.
Changes in health-related quality of life - Visual Analogue Scale (VAS)
Questionnaires - Units on a Scale from 0-10 cm with lower score identifying better outcomes
Measured: 4 weeks before the intervention, at baseline and after 20 training sessions during 4 weeks weeks of rehabilitation.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Oct 2022
- Study start15 Nov 2022 (estimated)
- Primary completion30 Jun 2024 (estimated)
- Study completion30 Jun 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Obstructive Pulmonary DiseaseStudies of the same condition, open and under way.
- 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
- Not applicable
- Intervention model
- Single group
- Model description
- Pre-test 4 weeks before the intervention period (Subjects functioning as their own control), tests at baseline and 4 weeks after the intervention period.
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Molde University College
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jan Helgerud, PhD, Principal investigator, Norwegian University of Science and Technology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05586399
- Sponsor's protocol ID
- NA -COPD
- Status last verified
- Sep 2022
- First submitted
- 6 Sep 2022
- Last updated
- 19 Oct 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Maximal Strength Training on Lung Function in Patients With COPD
- ClinicalTrials.gov ID
- NCT05586399
- Acronym / sponsor ID
- NA -COPD
- Conditions
- Chronic Obstructive Pulmonary Disease
- Keywords
- Strength training, Lung function, Quality of life
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Molde University CollegeUniversity, hospital or other
- Study start
- 15 Nov 2022 (estimated)
- Primary completion
- 30 Jun 2024 (estimated)
- Study completion
- 30 Jun 2024 (estimated)
- First posted
- 19 Oct 2022 (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.
The purpose of this study is to investigate the effect on maximal strength training on muscle function, lung function and quality of life for patients diagnosed with COPD grade II-III (Gold scale). Each patient will complete a total of 20 exercise session participating in a rehabilitation program for 4 weeks. Physiological and functional testing will be performed 4 weeks before the training intervention, at baseline and after the intervention period.
Detailed description
COPD is a group of diseases which affect the pulmonary system and leads to airflow restrictions and breathing difficulty. Other healthcare related problems, such as chronic inflammation, reduced muscle function, anxiety, depression and cardiovascular diseases are often seen in patients who are diagnosed with COPD.
Frequent participation in physical activity has been shown to improve the general public health, and serve as a prevention for development of various chronic diseases. Physical activity has at the same time been shown to be effective in treatment of both pulmonary and cardiovascular diseases. It also has the potential to reduce the need for health services, and can replace or reduce the need for medicinal treatments.
In this study we are want to investigate the effect of maximal strength training in COPD patients grade II-III on both muscle function and lung function. Maximal strength training (MST) have previously been shown as a superior intervention to achieve increased 1RM and fast development of power, also known as rate of force development (RFD). Lung function in COPD patients has been shown in previous research to be improved following maximal strength training.
The participants will partake in a total of 20 MST interventions during a rehabilitation period of 4 weeks. The sessions will be distributed five times a week located in two different Rehabilitation Centers in Trondheim, Norway. The strength training will be performed in groups, supervised by one or more coworkers in the project. MST will be performed with 4 series of 4 RM in a horizontal leg press machine, supervised by a coworker in the project. As part of the rehabilitation program, participants will also perform endurance training parallell to the MST sessions.
The participants will function as their own control group in the project. They will participate in a pre-test 4 weeks before the intervention period. After the pre-test they will be instructed to live as usual for the next 4 weeks. They will then start the intervention period, with tests performed at start and end of the period.
Both subjective and objective measurements will be performed 4 weeks before, at baseline and after the intervention period. All physiological tests will be completed during the same day. A standardized work economy test on a treadmill will be used in assessment of endurance capacity, with an expected duration of 4 minutes. The work economy test will be followed by a standardized graded test of maximal oxygen consumption, with a maximal duration of 10 minutes. Both endurance tests will be performed on a treadmill, with continuous heart rate monitoring. Approximately 5-10 minutes after finishing the endurance tests, a test of maximal dynamic strength will be performed (1RM test). The test will be performed in a horizontal leg press machine. After three submaximal warm-up sets, the load will be gradually increased until the participant fails to perform the test. Duration of rest periods between sets will be standardized to 3 minutes. Rate of force development will also be assessed, with the use of a force plate in the same horizontal leg press machine. There will also be performed functional tests (6 minute walk test, Timed Up and Go and stair climb test). All participants will also answer standardized questionnaires regarding health related quality of life.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Pre-test 4 weeks before the intervention period (Subjects functioning as their own control), tests at baseline and 4 weeks after the intervention period.
| Arm | Type | Receives |
|---|---|---|
| Exercise intervention | Experimental | Behavioral: Maximal strength training in COPDParticipants performing a rehabilitation program for 5 times a week in a total of 4 weeks in one of two rehabilitation centers in Trondheim, Norway. The aim is to perform a total of 20 maximal strength training interventions supervised by one or more health professionals. Maximal strength training will be performed with 4 repetitions and 4 series at 90-95% of one repetition maximum. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- COPD-diagnosis grade II-III (Gold Classification)
- Patients in one of two rehabilitation centres in Trondheim, Norway.
- Must be able to perform the test procedures walking or running on a treadmill.
- Must participate in at least 18 of the 20 planned training sessions.
Key exclusion criteria (4 listed)
- Other pulmonary disease than COPD
- Diabetes mellitus or other metabolic diseases
- Use of corticosteroids the last 6 weeks
- Pulmonary infection the last 4 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 |
|---|---|---|
| Maximal strength training in COPDParticipate in a rehabilitation program for 4 weeks, with exercise 5 times a week. Supervised maximal strength training in a leg press machine for a total of 20 exercise sessions. Patients will participate in rehabilitation in one of two rehabilitations centers in Trondheim, Norway. | Behavioural | Exercise intervention |
Primary outcome
Change in Maximal Strenght
Time frame: 4 weeks before the intervention, at baseline and after 20 training sessions during 4 weeks weeks of rehabilitation.
Measured in 1 repetition maximum (kg) in leg press.
Change in Rate of Force Development
Time frame: 4 weeks before the intervention, at baseline and after 20 training sessions during 4 weeks weeks of rehabilitation.
Measured in Newton using a force plate
Change in Forced Expiratory Volume (FEV1)
Time frame: 4 weeks before the intervention, at baseline and after 20 training sessions during 4 weeks weeks of rehabilitation.
Measured using spirometry as the maximal volume of air (liter) exhaled in the first second of expiration
Change in Peak Expiratory Flow (PEF)
Time frame: 4 weeks before the intervention, at baseline and after 20 training sessions during 4 weeks weeks of rehabilitation.
Measured using spirometry as the maximal speed of expiration (Measured as liter/min)
Change in Work Economy
Time frame: 4 weeks before the intervention, at baseline and after 20 training sessions during 4 weeks weeks of rehabilitation.
Measured using CPET walking on a treadmill at a standardized speed and incline (Measured as VO2 ml/kg/min)
Change in Maximal Oxygen Consumption
Time frame: 4 weeks before the intervention, at baseline and after 20 training sessions during 4 weeks weeks of rehabilitation.
Measured using CPET in maximal test walking until exhaustion(Measured as VO2 ml/kg/min)
Change in Stair Climbing-test
Time frame: 4 weeks before the intervention, at baseline and after 20 training sessions during 4 weeks weeks of rehabilitation.
Measured in seconds as the average of two attempts
Change in Timed up and Go-test
Time frame: 4 weeks before the intervention, at baseline and after 20 training sessions during 4 weeks weeks of rehabilitation.
Measured in seconds as the average of two attempts
Change in 6 Minutes Walk Test
Time frame: 4 weeks before the intervention, at baseline and after 20 training sessions during 4 weeks weeks of rehabilitation.
Measured in meters
5 secondary outcomes
Changes in health-related quality of life - Norwegian RAND36
Time frame: 4 weeks before the intervention, at baseline and after 20 training sessions during 4 weeks weeks of rehabilitation.
Changes in health-related quality of life - Hospital and Anxiety Score (HADS)
Time frame: 4 weeks before the intervention, at baseline and after 20 training sessions during 4 weeks weeks of rehabilitation.
Changes in health-related quality of life - International physical activity questionnaire (IPAQ)
Time frame: 4 weeks before the intervention, at baseline and after 20 training sessions during 4 weeks weeks of rehabilitation.
Changes in health-related quality of life - EQ-5D-5L
Time frame: 4 weeks before the intervention, at baseline and after 20 training sessions during 4 weeks weeks of rehabilitation.
Changes in health-related quality of life - Visual Analogue Scale (VAS)
Time frame: 4 weeks before the intervention, at baseline and after 20 training sessions during 4 weeks weeks of rehabilitation.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Oct 2022.
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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.
Jan Helgerud, PhD contact
Jan Helgerud, PhD principal investigator
Norwegian University of Science and Technology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Maximal strength training in COPD in people with Chronic Obstructive Pulmonary Disease, run by Molde University College at 1 site in Norway.
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 4 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: status not confirmed, as of the sponsor's last update on 19 Oct 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Norway. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Norun Aagård, Msc (+ 99364951, norun.aagaard@treningsklinikken.no), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Maximal Strenght (time frame: 4 weeks before the intervention, at baseline and after 20 training sessions during 4 weeks weeks of rehabilitation.). The study lists 9 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 19 Oct 2022.