COPDNCT02050945
The Effects of Physical Exercise Training in Patients With Chronic Obstructive Pulmonary Disease
A study testing Resistance training and Endurance training in people with COPD and Exercise, run by Copenhagen University Hospital, Rigshospitalet at 2 sites in Denmark.
Trial summary
The purpose of the present project is to investigate the physiological effects of two different types of exercise training in COPD patients. The patients will be examined before, during and after 8 weeks of training to evaluate the effect of different types of skeletal muscle stimulation on health related quality of… Read more about this study
- Who is it for?
- Ages 40 to 80 years
- Conditions the study is for
- COPD, Exercise, Resistance Training
- What is being tested?
- Resistance training and Endurance training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 2 sitesDenmark
- Study dates
- Jan 2014to Mar 2015
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- FEV1/FVC fixed ratio <0.70, FEV1: <60% of predicted and MRC > or equal to 3
- Arterial oxygen saturation at rest> 90%, BMI >18, LVEF> 45.
- Age: 40 - 80 years
- The medical treatment will be continued unchanged during the study and additional prednisolone and /or antibiotic treatment will be prescribed in case of acute exacerbation.
Who cannot join
- Unstable ischemic heart disease, severe heart valve failure, pulmonary emboli, severe heart failure, severe infections, musculoskeletal disorders, malignant disease, contraindicated medicine as MAO inhibitors and anticoagulants.
Trial locations and contacts
2 sites in 1 country.
Denmark2 sites
Centre of Physical Activity Resarch
Copenhagen, Capital Region, 2100
Centre of Physical Activity Research
Copenhagen, Capital Region, 2100
About this study
The purpose of the present project is to investigate the physiological effects of two different types of exercise training in COPD patients. The patients will be examined before, during and after 8 weeks of training to evaluate the effect of different types of skeletal muscle stimulation on health related quality of life, 6 min walking distance, flow mediated dilation, and histological properties of skeletal muscle cells, regarding oxidative capacity, fiber type, purinergic receptor amounts and measures of systemic inflammation. The study will test the hypothesis that:
Resistance training is superior to endurance training in patients with COPD
- Conditions
- COPD, Exercise, Resistance Training
- Being tested
- Resistance training, Endurance training
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Resistance trainingBehavioural
Also called Strength training, skeletal muscle, exercise, muscle training
Endurance trainingBehavioural
| Study group | Role | What they receive |
|---|---|---|
| Patients with COPD | Experimental | Patients with COPD are to be trained 3 times a week for 8 weeks Receives: Behavioral: Resistance training |
| Control patients with COPD | Active comparator | Control patients with COPD are to be trained 3 times a week for 8 weeks Receives: Behavioral: Endurance training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Skeletal muscle function
Muscle biopsy
Measured: At baseline and after 8 weeks of traning
Secondary outcomes (4)
Flow mediated dilation
Endothelium function
Measured: Change from baseline at 8 weeks
Body composition
DEXA scan
Measured: Change from baseline at 8 weeks
6 min walking test
Measured: Change from baseline at 8 weeks
Health Related Quality of Life - COPD assessment test (CAT)
Measured: Change from baseline at 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jan 2014 (estimated)
- Study startJan 2014
- Primary completionMar 2015
- Study completionMar 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COPDStudies of the same condition, open and under way.
- More trials run by Copenhagen University Hospital, RigshospitaletThe 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Copenhagen University Hospital, Rigshospitalet
- Sponsor type
- University, hospital or other
- Collaborators
- Copenhagen University Hospital, Hvidovre
- Responsible party
- Principal investigator, Anders Rasmussen Rinnov, Copenhagen University Hospital, Rigshospitalet
- Investigators
- Stefan Mortensen, DMSc, Study chair, Centre of Inflammation and Metabolism, University of Copenhagen, Rigshospitalet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02050945
- Sponsor's protocol ID
- H-2-2013-150
- Status last verified
- Apr 2015
- First submitted
- 27 Jan 2014
- Last updated
- 21 Apr 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 21 Apr 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Physical Exercise Training in Patients With Chronic Obstructive Pulmonary Disease
- ClinicalTrials.gov ID
- NCT02050945
- Acronym / sponsor ID
- H-2-2013-150
- Conditions
- COPD, Exercise, Resistance Training
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Copenhagen University Hospital, RigshospitaletUniversity, hospital or other
- Collaborators
- Copenhagen University Hospital, Hvidovre
- Study start
- Jan 2014
- Primary completion
- Mar 2015 (actual)
- Study completion
- Mar 2015 (actual)
- First posted
- 31 Jan 2014 (estimated)
- 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 the present project is to investigate the physiological effects of two different types of exercise training in COPD patients. The patients will be examined before, during and after 8 weeks of training to evaluate the effect of different types of skeletal muscle stimulation on health related quality of life, 6 min walking distance, flow mediated dilation, and histological properties of skeletal muscle cells, regarding oxidative capacity, fiber type, purinergic receptor amounts and measures of systemic inflammation. The study will test the hypothesis that:
Resistance training is superior to endurance training in patients with COPD
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patients with COPD | Experimental | Behavioral: Resistance trainingPatients with COPD are to be trained 3 times a week for 8 weeks |
| Control patients with COPD | Active comparator | Behavioral: Endurance trainingControl patients with COPD are to be trained 3 times a week for 8 weeks |
Who may qualify
- Ages
- 40 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- FEV1/FVC fixed ratio <0.70, FEV1: <60% of predicted and MRC > or equal to 3
- Arterial oxygen saturation at rest> 90%, BMI >18, LVEF> 45.
- Age: 40 - 80 years
- The medical treatment will be continued unchanged during the study and additional prednisolone and /or antibiotic treatment will be prescribed in case of acute exacerbation.
Key exclusion criteria (1 listed)
- Unstable ischemic heart disease, severe heart valve failure, pulmonary emboli, severe heart failure, severe infections, musculoskeletal disorders, malignant disease, contraindicated medicine as MAO inhibitors and anticoagulants.
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 |
|---|---|---|
| Resistance trainingAlso: Strength training, skeletal muscle, exercise, muscle training | Behavioural | Patients with COPD |
| Endurance training | Behavioural | Control patients with COPD |
Primary outcome
Skeletal muscle function
Time frame: At baseline and after 8 weeks of traning
Muscle biopsy
4 secondary outcomes
Flow mediated dilation
Time frame: Change from baseline at 8 weeks
Body composition
Time frame: Change from baseline at 8 weeks
6 min walking test
Time frame: Change from baseline at 8 weeks
Health Related Quality of Life - COPD assessment test (CAT)
Time frame: Change from baseline at 8 weeks
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 21 Apr 2015.
Related trials for COPD
Active, not recruiting
Symptoms and Functions in Patients With COPD and Chronic Bronchitis Switching From CIG to THS
COPD, Smoking
Not yet recruitingPhase 2/3
An Open-Label Extension Study to Evaluate Inhaled Treprostinil SMI in Participants With Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease (PH-COPD)
Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease
Not yet recruiting
The Aim of the Study is to Decipher the Alterations in Signalling Pathways of Skeletal Muscle Stem Cells (Satellite Cells (SCs)) in Individuals With COPD, as Well as to Examine the Effect of Exercise Training on SCs.
COPD (Chronic Obstructive Pulmonary Disease), Sarcopenia in Elderly
Not yet recruitingPhase 2
Study of Treprostinil Administered Via Soft Mist Inhaler (SMI) in Participants With Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease (PH-COPD)
Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease
Active, not recruitingPhase 1
A Study for GSK3862995B in Healthy Participants and Participants With Chronic Obstructive Pulmonary Disease
Pulmonary Disease, Chronic Obstructive
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.
Stefan Mortensen, DMSc study chair
Centre of Inflammation and Metabolism, University of Copenhagen, Rigshospitalet
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Resistance training and Endurance training in people with COPD and Exercise, run by Copenhagen University Hospital, Rigshospitalet at 2 sites in Denmark.
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 1 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 21 Apr 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Denmark. 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?
Skeletal muscle function (time frame: At baseline and after 8 weeks of traning). 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 21 Apr 2015.