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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT02757157
Other study ID # ERS STRTF 2015 - 9368
Secondary ID
Status Terminated
Phase N/A
First received
Last updated
Start date October 2016
Est. completion date January 1, 2020

Study information

Verified date August 2021
Source European Respiratory Society
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.


Recruitment information / eligibility

Status Terminated
Enrollment 14
Est. completion date January 1, 2020
Est. primary completion date January 1, 2020
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Behavioral:
Water-based walking
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.
Land-based walking
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.

Locations

Country Name City State
Netherlands Centre of intergrated rehabilitation for chronic organ failure Horn

Sponsors (2)

Lead Sponsor Collaborator
European Respiratory Society Center for Integrated Rehabilitation and Organ Failure Horn

Country where clinical trial is conducted

Netherlands, 

Outcome

Type Measure Description Time frame Safety issue
Other Dyspnoea, measured by the modified Borg 0-10 category ratio scale Day of assessment during study measurement period (15 minutes)
Other Exertion, measured by the modified Borg 0-10 category ratio scale Day of assessment during study measurement period (15 minutes)
Other Oxygen saturation Day of assessment during study measurement period (15 minutes)
Other Heart rate Day of assessment during study measurement period (15 minutes)
Primary Breath-by-breath oxygen consumption (VO2) Day of assessment during study measurement period (15 minutes)
Secondary Minute ventilation (VE) Day of assessment during study measurement period (15 minutes)
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