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

NCT02757157 | Terminated DMC

• 1 other identifier: ERS STRTF 2015 - 9368
• Study Type: interventional
• Target: 14
• Locations: 1 country
• Sites: 1

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.

Conditions

Pulmonary Disease, Chronic Obstructive

Keywords

Hydrotherapy; Walking

Outcome Measures

Primary Outcomes (1)

• Breath-by-breath oxygen consumption (VO2)

  Day of assessment during study measurement period (15 minutes)

Secondary Outcomes (1)

• Minute ventilation (VE)

  Day of assessment during study measurement period (15 minutes)

Other Outcomes (4)

• Dyspnoea, measured by the modified Borg 0-10 category ratio scale

  Day of assessment during study measurement period (15 minutes)

• Exertion, measured by the modified Borg 0-10 category ratio scale

  Day of assessment during study measurement period (15 minutes)

• Oxygen saturation

  Day of assessment during study measurement period (15 minutes)

Study Arms (2)

COPD (normal weight)

EXPERIMENTAL

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

Behavioral: Water-based walking; Behavioral: Land-based walking

COPD (obese)

EXPERIMENTAL

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

Behavioral: Water-based walking; Behavioral: Land-based walking

Interventions

Water-based walking BEHAVIORAL

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.

COPD (normal weight); COPD (obese)

Land-based walking BEHAVIORAL

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.

COPD (normal weight); COPD (obese)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• long-term oxygen therapy
• contraindications to entering a hydrotherapy pool

Sponsors & Collaborators

• European Respiratory Society: lead
• Center for Integrated Rehabilitation and Organ Failure Horn: collaborator

Study Sites (1)

Centre of intergrated rehabilitation for chronic organ failure

Horn, Netherlands

Location

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Martijn A Spruit, PhD

  Centre of integrated rehabilitation for chronic organ failure

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Specialist Physiotherapist

Study Record Dates

• First Submitted: April 7, 2016
• First Posted: April 29, 2016
• Study Start: October 1, 2016
• Primary Completion: January 1, 2020
• Study Completion: January 1, 2020
• Last Updated: August 25, 2021

Record last verified: 2021-08

Data Sharing

• IPD Sharing: Will not share

Locations

NL (1)