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

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ClinicalTrials.gov Identifier: NCT02757157
Recruitment Status : Recruiting
First Posted : April 29, 2016
Last Update Posted : February 12, 2019
Sponsor:
Collaborator:
Center for Integrated Rehabilitation and Organ Failure Horn
Information provided by (Responsible Party):
Renae McNamara, European Respiratory Society

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.


Condition or disease Intervention/treatment Phase
Pulmonary Disease, Chronic Obstructive Behavioral: Water-based walking Behavioral: Land-based walking Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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 Start Date : October 2016
Estimated Primary Completion Date : December 2019
Estimated Study Completion Date : December 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: COPD (normal weight)
People with COPD (BMI 21 kg/m2 to 29 kg/m2)
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.


Behavioral: 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.


Experimental: COPD (obese)
People with COPD (BMI >/= 30 kg/m2)
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.


Behavioral: 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.





Primary Outcome Measures :
  1. Breath-by-breath oxygen consumption (VO2) [ Time Frame: Day of assessment during study measurement period (15 minutes) ]

Secondary Outcome Measures :
  1. Minute ventilation (VE) [ Time Frame: Day of assessment during study measurement period (15 minutes) ]

Other Outcome Measures:
  1. Dyspnoea, measured by the modified Borg 0-10 category ratio scale [ Time Frame: Day of assessment during study measurement period (15 minutes) ]
  2. Exertion, measured by the modified Borg 0-10 category ratio scale [ Time Frame: Day of assessment during study measurement period (15 minutes) ]
  3. Oxygen saturation [ Time Frame: Day of assessment during study measurement period (15 minutes) ]
  4. Heart rate [ Time Frame: Day of assessment during study measurement period (15 minutes) ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02757157


Contacts
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Contact: Renae J McNamara, PhD +61411055802 renae.mcnamara@health.nsw.gov.au

Locations
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Netherlands
Centre of intergrated rehabilitation for chronic organ failure Recruiting
Horn, Netherlands
Contact: Renae J McNamara, PhD, BAppSc(Phty)    447978386404    renae.mcnamara@health.nsw.gov.au   
Contact: Martijn A Spruit, PhD    +31646257310    martijnspruit@ciro-horn.nl   
Sponsors and Collaborators
European Respiratory Society
Center for Integrated Rehabilitation and Organ Failure Horn
Investigators
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Study Director: Martijn A Spruit, PhD Centre of integrated rehabilitation for chronic organ failure

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Responsible Party: Renae McNamara, Clinical Specialist Physiotherapist, European Respiratory Society
ClinicalTrials.gov Identifier: NCT02757157     History of Changes
Other Study ID Numbers: ERS STRTF 2015 - 9368
First Posted: April 29, 2016    Key Record Dates
Last Update Posted: February 12, 2019
Last Verified: February 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Renae McNamara, European Respiratory Society:
Hydrotherapy
Walking

Additional relevant MeSH terms:
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Lung Diseases
Pulmonary Disease, Chronic Obstructive
Chronic Disease
Respiratory Tract Diseases
Lung Diseases, Obstructive
Disease Attributes
Pathologic Processes