Pulmonary Disease, Chronic ObstructiveNCT02757157
Comparison of Walking in Water and on Land in People With Chronic Obstructive Pulmonary Disease (COPD)
A study testing Water-based walking and Land-based walking in people with Pulmonary Disease, Chronic Obstructive, run by European Respiratory Society at 1 site in Netherlands.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pulmonary Disease, Chronic Obstructive
- What is being tested?
- Water-based walking and Land-based walking
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 14 participants
- Where
- 1 siteNetherlands
- Study dates
- Oct 2016to 1 Jan 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- long-term oxygen therapy
- contraindications to entering a hydrotherapy pool
Trial locations and contacts
1 site in 1 country.
Netherlands1 site
Centre of intergrated rehabilitation for chronic organ failure
Horn
About this study
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
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
- Being tested
- Water-based walking, Land-based walking
- Keywords
- Hydrotherapy, Walking
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Water-based walkingBehavioural
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 walkingBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| COPD (normal weight) | Experimental | People with COPD (BMI 21 kg/m2 to 29 kg/m2) Receives: Behavioral: Water-based walking; Behavioral: Land-based walking |
| COPD (obese) | Experimental | People with COPD (BMI >/= 30 kg/m2) Receives: Behavioral: Water-based walking; Behavioral: Land-based walking |
What is being measured
The primary outcome is the main question the study is designed to answer.
Breath-by-breath oxygen consumption (VO2)
Measured: Day of assessment during study measurement period (15 minutes)
Secondary outcomes (1)
Minute ventilation (VE)
Measured: Day of assessment during study measurement period (15 minutes)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Apr 2016 (estimated)
- Study startOct 2016
- Primary completion1 Jan 2020
- Study completion1 Jan 2020
Why it stopped: Hydrotherapy pool has closed.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pulmonary Disease, Chronic ObstructiveStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 14 participants (actual)
Sponsor and investigators
- Lead sponsor
- European Respiratory Society
- Sponsor type
- University, hospital or other
- Collaborators
- Center for Integrated Rehabilitation and Organ Failure Horn
- Responsible party
- Principal investigator, Renae McNamara, European Respiratory Society
- Investigators
- Martijn A Spruit, PhD, Study director, Centre of integrated rehabilitation for chronic organ failure
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02757157
- Sponsor's protocol ID
- ERS STRTF 2015 - 9368
- Status last verified
- Aug 2021
- First submitted
- 7 Apr 2016
- Last updated
- 25 Aug 2021
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02757157
- Acronym / sponsor ID
- ERS STRTF 2015 - 9368
- Conditions
- Pulmonary Disease, Chronic Obstructive
- Keywords
- Hydrotherapy, Walking
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Hydrotherapy pool has closed.
- Enrolment
- 14 participants (actual)
- Lead sponsor
- European Respiratory SocietyUniversity, hospital or other
- Collaborators
- Center for Integrated Rehabilitation and Organ Failure Horn
- Study start
- Oct 2016
- Primary completion
- 1 Jan 2020 (actual)
- Study completion
- 1 Jan 2020 (actual)
- First posted
- 29 Apr 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| COPD (normal weight) | Experimental | Behavioral: Water-based walking, Behavioral: Land-based walkingPeople with COPD (BMI 21 kg/m2 to 29 kg/m2) |
| COPD (obese) | Experimental | Behavioral: Water-based walking, Behavioral: Land-based walkingPeople with COPD (BMI >/= 30 kg/m2) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (2 listed)
- long-term oxygen therapy
- contraindications to entering a hydrotherapy pool
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Water-based walkingParticipants 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. | Behavioural | COPD (normal weight), COPD (obese) |
| Land-based walkingParticipants 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. | Behavioural | COPD (normal weight), COPD (obese) |
Primary outcome
Breath-by-breath oxygen consumption (VO2)
Time frame: Day of assessment during study measurement period (15 minutes)
1 secondary outcome
Minute ventilation (VE)
Time frame: Day of assessment during study measurement period (15 minutes)
Results and safety
The study was stopped early (reason given: Hydrotherapy pool has closed.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Aug 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Martijn A Spruit, PhD study director
Centre of integrated rehabilitation for chronic organ failure
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Water-based walking and Land-based walking in people with Pulmonary Disease, Chronic Obstructive, run by European Respiratory Society at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 25 Aug 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Hydrotherapy pool has closed.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Breath-by-breath oxygen consumption (VO2) (time frame: Day of assessment during study measurement period (15 minutes)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Aug 2021.