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Comparison of Walking in Water and on Land in People With Chronic Obstructive Pulmonary Disease (COPD)

Primary Purpose

Pulmonary Disease, Chronic Obstructive

Status

Terminated

Phase

Not Applicable

Locations

Netherlands

Study Type

Interventional

Intervention

Water-based walking

Land-based walking

About this trial

This is an interventional treatment trial for Pulmonary Disease, Chronic Obstructive focused on measuring Hydrotherapy, Walking

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Centre of intergrated rehabilitation for chronic organ failure

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Arm Label

COPD (normal weight)

COPD (obese)

Arm Description

People with COPD (BMI 21 kg/m2 to 29 kg/m2)

People with COPD (BMI >/= 30 kg/m2)

Outcomes

Primary Outcome Measures

Breath-by-breath oxygen consumption (VO2)

Secondary Outcome Measures

Minute ventilation (VE)

Full Information

NCT ID

NCT02757157

First Posted

April 7, 2016

Last Updated

August 19, 2021

Sponsor

European Respiratory Society

Collaborators

Center for Integrated Rehabilitation and Organ Failure Horn

1. Study Identification

Unique Protocol Identification Number

NCT02757157

Brief Title

Comparison of Walking in Water and on Land in People With Chronic Obstructive Pulmonary Disease (COPD)

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

August 2021

Overall Recruitment Status

Terminated

Why Stopped

Hydrotherapy pool has closed.

Study Start Date

October 2016 (undefined)

Primary Completion Date

January 1, 2020 (Actual)

Study Completion Date

January 1, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

European Respiratory Society

Collaborators

Center for Integrated Rehabilitation and Organ Failure Horn

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Pulmonary Disease, Chronic Obstructive

Keywords

Hydrotherapy, Walking

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Crossover Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

14 (Actual)

8. Arms, Groups, and Interventions

Arm Title

COPD (normal weight)

Arm Type

Experimental

Arm Description

People with COPD (BMI 21 kg/m2 to 29 kg/m2)

Arm Title

COPD (obese)

Arm Type

Experimental

Arm Description

People with COPD (BMI >/= 30 kg/m2)

Intervention Type

Behavioral

Intervention Name(s)

Water-based walking

Intervention Description

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.

Intervention Type

Behavioral

Intervention Name(s)

Land-based walking

Intervention Description

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.

Primary Outcome Measure Information:

Title

Breath-by-breath oxygen consumption (VO2)

Time Frame