- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02757157
Comparison of Walking in Water and on Land in People With Chronic Obstructive Pulmonary Disease (COPD)
Determining the Metabolic Load of Walking in Water Compared to Walking on Land in People With COPD, Who Are Normal Weight and Obese, Compared to Peak Exercise Metabolic Response: a Prospective, Randomised Cross-over Pilot Trial
The purpose of this study is to evaluate the metabolic load during a single session of moderate intensity walking in water compared to walking on land (over-ground) in people with chronic obstructive pulmonary disease (COPD) who are normal weight and obese, compared with peak exercise metabolic response.
The hypothesis is that the metabolic load of walking at a moderate intensity in water will be greater than walking on land.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Horn, Netherlands
- Centre of intergrated rehabilitation for chronic organ failure
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- diagnosis of COPD (FEV1/FVC <0.7) in a clinically stable state (no acute exacerbation of COPD within the previous 4 weeks)
- accepting of walking in water
- BMI >/= 21 kg/m2
Exclusion Criteria:
- long-term oxygen therapy
- contraindications to entering a hydrotherapy pool
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: COPD (normal weight)
People with COPD (BMI 21 kg/m2 to 29 kg/m2)
|
Participants will walk in the water for 15 minutes at an intensity rating of five on the modified Borg scale for dyspnoea or perceived exertion, whichever is the highest. Walking intensity will be measured every three minutes during each walking session. If the intensity level is reported as below five, participants will be encouraged to increase the intensity by increasing their walking speed. During walking in water, VO2 and VE will be measured breath-by-breath using the Oxycon mobile. Every three minutes during the walking, heart rate, oxygen saturation, dyspnoea and exertion will be measured. Participants will walk on land for 15 minutes at an intensity rating of five on the modified Borg scale for dyspnoea or perceived exertion, whichever is the highest. Walking intensity will be measured every three minutes during each walking session. If the intensity level is reported as below five, participants will be encouraged to increase the intensity by increasing their walking speed. During walking on land, VO2 and VE will be measured breath-by-breath using the Oxycon mobile. Every three minutes during the walking, heart rate, oxygen saturation, dyspnoea and exertion will be measured. |
|
Experimental: COPD (obese)
People with COPD (BMI >/= 30 kg/m2)
|
Participants will walk in the water for 15 minutes at an intensity rating of five on the modified Borg scale for dyspnoea or perceived exertion, whichever is the highest. Walking intensity will be measured every three minutes during each walking session. If the intensity level is reported as below five, participants will be encouraged to increase the intensity by increasing their walking speed. During walking in water, VO2 and VE will be measured breath-by-breath using the Oxycon mobile. Every three minutes during the walking, heart rate, oxygen saturation, dyspnoea and exertion will be measured. Participants will walk on land for 15 minutes at an intensity rating of five on the modified Borg scale for dyspnoea or perceived exertion, whichever is the highest. Walking intensity will be measured every three minutes during each walking session. If the intensity level is reported as below five, participants will be encouraged to increase the intensity by increasing their walking speed. During walking on land, VO2 and VE will be measured breath-by-breath using the Oxycon mobile. Every three minutes during the walking, heart rate, oxygen saturation, dyspnoea and exertion will be measured. |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Breath-by-breath oxygen consumption (VO2)
Time Frame: Day of assessment during study measurement period (15 minutes)
|
Day of assessment during study measurement period (15 minutes)
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Minute ventilation (VE)
Time Frame: Day of assessment during study measurement period (15 minutes)
|
Day of assessment during study measurement period (15 minutes)
|
Other Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Dyspnoea, measured by the modified Borg 0-10 category ratio scale
Time Frame: Day of assessment during study measurement period (15 minutes)
|
Day of assessment during study measurement period (15 minutes)
|
|
Exertion, measured by the modified Borg 0-10 category ratio scale
Time Frame: Day of assessment during study measurement period (15 minutes)
|
Day of assessment during study measurement period (15 minutes)
|
|
Oxygen saturation
Time Frame: Day of assessment during study measurement period (15 minutes)
|
Day of assessment during study measurement period (15 minutes)
|
|
Heart rate
Time Frame: Day of assessment during study measurement period (15 minutes)
|
Day of assessment during study measurement period (15 minutes)
|
Collaborators and Investigators
Sponsor
Investigators
- Study Director: Martijn A Spruit, PhD, Centre of integrated rehabilitation for chronic organ failure
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- ERS STRTF 2015 - 9368
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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