Back to resultsA 12 Week Physical Training Programme for Patients With Chronic Obstructive Pulmonary Disease
Primary Purpose
Chronic Obstructive Pulmonary Disease
Status
Completed
Phase
Not Applicable
Locations
Norway
Study Type
Interventional
Intervention
Training in water
Training on land
Sponsored by
About this trial
This is an interventional prevention trial for Chronic Obstructive Pulmonary Disease focused on measuring Chronic Obstructive Pulmonary Disease, COPD, Physical group training, Water exercise, Cardiorespiratory fitness, Functional exercise capacity, Health related quality of life
Eligibility Criteria
Inclusion Criteria:
- COPD GOLD II
- Not taking part in physical activity during the last year
Exclusion Criteria:
- COPD GOLD I, III, IV
- Pain in the legs that make activity difficult
Sites / Locations
- Levanger Hosp
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
B1
S1
Arm Description
B1 - training in water
S1 - training on land
Outcomes
Primary Outcome Measures
VO2 peak
Secondary Outcome Measures
Health related quality of life
Full Information
NCT ID
NCT00744484
First Posted
August 29, 2008
Last Updated
February 18, 2022
Sponsor
Norwegian University of Science and Technology
Collaborators
Helse Nord-Trøndelag HF, Nord-Trøndelag University College
1. Study Identification
Unique Protocol Identification Number
NCT00744484
Brief Title
A 12 Week Physical Training Programme for Patients With Chronic Obstructive Pulmonary Disease
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
Study Type
Interventional
2. Study Status
Record Verification Date
February 2022
Overall Recruitment Status
Completed
Study Start Date
February 2008 (Actual)
Primary Completion Date
May 2009 (Actual)
Study Completion Date
September 2010 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Norwegian University of Science and Technology
Collaborators
Helse Nord-Trøndelag HF, Nord-Trøndelag University College
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
22 (Actual)
8. Arms, Groups, and Interventions
Arm Title
B1
Arm Type
Experimental
Arm Description
B1 - training in water
Arm Title
S1
Arm Type
Experimental
Arm Description
S1 - training on land
Intervention Type
Behavioral
Intervention Name(s)
Training in water
Intervention Description
45 minutes interval training in water, submaximal intensity, twice a week
Intervention Type
Behavioral
Intervention Name(s)
Training on land
Intervention Description
45 minutes interval training on land, submaximal intensity, twice a week
Primary Outcome Measure Information:
Title
VO2 peak
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
Health related quality of life
Time Frame
12 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
50 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
COPD GOLD II
Not taking part in physical activity during the last year
Exclusion Criteria:
COPD GOLD I, III, IV
Pain in the legs that make activity difficult
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Thor Naustdal, MD
Organizational Affiliation
Hospital of Levanger / NTNU ISB
Official's Role
Principal Investigator
Facility Information:
Facility Name
Levanger Hosp
City
Levanger
State/Province
Nord-Trøndelag
ZIP/Postal Code
7600
Country
Norway
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
A 12 Week Physical Training Programme for Patients With Chronic Obstructive Pulmonary Disease
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