Chronic Obstructive Pulmonary DiseaseNCT00744484
A 12 Week Physical Training Programme for Patients With Chronic Obstructive Pulmonary Disease
A study testing Training in water and Training on land in people with Chronic Obstructive Pulmonary Disease, run by Norwegian University of Science and Technology at 1 site in Norway.
Trial summary
The purpose of this study is to determine whether water based or land based group training is more effective for people with COPD. Read more about this study
- Who is it for?
- Ages 50 to 75 years
- Conditions the study is for
- Chronic Obstructive Pulmonary Disease
- What is being tested?
- Training in water and Training on land
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 22 participants
- Where
- 1 siteNorway
- Study dates
- Feb 2008to Sep 2010
- 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 50 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- COPD GOLD II
- Not taking part in physical activity during the last year
Who cannot join
- COPD GOLD I, III, IV
- Pain in the legs that make activity difficult
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A 12 Week Physical Training Programme for Patients With Chronic Obstructive Pulmonary Disease (COPD)-a Comparison of Water Based and Land Based Group Training
The purpose of this study is to determine whether water based or land based group training is more effective for people with COPD.
Read the detailed description
COPD is a more common diagnosis today compared to 20 years ago, and the group is growing fast. The suffering caused by COPD and the financial cost to society is on the increasing. The principal causes of COPD are smoking and inactivity. So far it is poorly understood wich form of exercise is the most effective in training this condition.
- Conditions
- Chronic Obstructive Pulmonary Disease
- Being tested
- Training in water, Training on land
- Keywords
- Chronic Obstructive Pulmonary Disease, COPD, Physical group training, Water exercise, Cardiorespiratory fitness, Functional exercise capacity, Health related 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.
Training in waterBehavioural
45 minutes interval training in water, submaximal intensity, twice a week
Training on landBehavioural
45 minutes interval training on land, submaximal intensity, twice a week
| Study group | Role | What they receive |
|---|---|---|
| B1 | Experimental | B1 - training in water Receives: Behavioral: Training in water |
| S1 | Experimental | S1 - training on land Receives: Behavioral: Training on land |
What is being measured
The primary outcome is the main question the study is designed to answer.
VO2 peak
Measured: 12 weeks
Secondary outcomes (1)
Health related quality of life
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Sep 2008 (estimated)
- Study startFeb 2008
- Primary completionMay 2009
- Study completionSep 2010
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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- Norwegian University of Science and Technology
- Sponsor type
- University, hospital or other
- Collaborators
- Helse Nord-Trøndelag HF, Nord-Trøndelag University College
- Responsible party
- Sponsor
- Investigators
- Thor Naustdal, MD, Principal investigator, Hospital of Levanger / NTNU ISB
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00744484
- Sponsor's protocol ID
- 4.2007.679 (REK)
- Other IDs
- 17117
- Status last verified
- Feb 2022
- First submitted
- 29 Aug 2008
- Last updated
- 7 Mar 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A 12 Week Physical Training Programme for Patients With Chronic Obstructive Pulmonary Disease (COPD)-a Comparison of Water Based and Land Based Group Training
- ClinicalTrials.gov ID
- NCT00744484
- Acronym / sponsor ID
- 4.2007.679 (REK)
- Conditions
- Chronic Obstructive Pulmonary Disease
- Keywords
- Chronic Obstructive Pulmonary Disease, COPD, Physical group training, Water exercise, Cardiorespiratory fitness, Functional exercise capacity, Health related quality of life
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- Norwegian University of Science and TechnologyUniversity, hospital or other
- Collaborators
- Helse Nord-Trøndelag HF, Nord-Trøndelag University College
- Study start
- Feb 2008 (actual)
- Primary completion
- May 2009 (actual)
- Study completion
- Sep 2010 (actual)
- First posted
- 1 Sep 2008 (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 this study is to determine whether water based or land based group training is more effective for people with COPD.
Detailed description
COPD is a more common diagnosis today compared to 20 years ago, and the group is growing fast. The suffering caused by COPD and the financial cost to society is on the increasing. The principal causes of COPD are smoking and inactivity. So far it is poorly understood wich form of exercise is the most effective in training this condition.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| B1 | Experimental | Behavioral: Training in waterB1 - training in water |
| S1 | Experimental | Behavioral: Training on landS1 - training on land |
Who may qualify
- Ages
- 50 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- COPD GOLD II
- Not taking part in physical activity during the last year
Key exclusion criteria (2 listed)
- COPD GOLD I, III, IV
- Pain in the legs that make activity difficult
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 |
|---|---|---|
| Training in water45 minutes interval training in water, submaximal intensity, twice a week | Behavioural | B1 |
| Training on land45 minutes interval training on land, submaximal intensity, twice a week | Behavioural | S1 |
Primary outcome
VO2 peak
Time frame: 12 weeks
1 secondary outcome
Health related quality of life
Time frame: 12 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 7 Mar 2022.
- Individual participant dataSharing planned: No
Related trials for Chronic Obstructive Pulmonary Disease
RecruitingPhase 2
PRA-216 COPD Safety and Biomarker Study
Chronic Obstructive Pulmonary Disease (COPD)
RecruitingPhase 2
Phase 2b Efficacy and Safety Study of AERO-007, an Inhaled LABA+LAMA Combination for Nebulization Delivery in COPD Patients
COPD, Chronic Obstructive Pulmonary Disease (COPD)
Enrolling by invitationObservational study
Firefighter's Longitudinal Airway and Respiratory Exposome/Multiome Study (FLARES)
Anosmia, Chronic Obstructive Pulmonary Disease
Active, not recruitingPhase 2
A Study to Evaluate Solrikitug in Participants With COPD (ZION)
COPD
RecruitingPhase 2
To Evaluate the Effect of EXPD-101/FXS7553 Compared With Placebo in Patients With COPD Over 52 Weeks of Treatment
Chronic Obstructive Pulmonary Disease (COPD)
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.
Thor Naustdal, MD principal investigator
Hospital of Levanger / NTNU ISB
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Training in water and Training on land in people with Chronic Obstructive Pulmonary Disease, run by Norwegian University of Science and Technology 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 2 inclusion and 2 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 7 Mar 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?
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?
VO2 peak (time frame: 12 weeks). 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 7 Mar 2022.