Chronic Obstructive Pulmonary Disease (COPD)GWT/TWTNCT02218918
Comparison of Supervised Ground Walk Training and Treadmill Walk Training in COPD Patients
A study testing Ground walk training and Supervised Treadmill Walk training in people with Chronic Obstructive Pulmonary Disease (COPD), run by PSG Hospitals at 1 site in India.
Trial summary
Pulmonary Rehabilitation became a vital part of management in COPD patients in form of activity modification, dietary and pharmacological optimisation. But access to traditional supervised aerobic (treadmill) walking is debatable fact due to economical and staffing expertise in developing countries like India. Read more about this study
- Who is it for?
- Ages 40 to 70 years
- Conditions the study is for
- Chronic Obstructive Pulmonary Disease (COPD)
- What is being tested?
- Ground walk training and Supervised Treadmill Walk training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteIndia
- Study dates
- Jul 2014to Oct 2016
- 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 40 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- stable COPD
- Stage II - IV
- Both genders
Who cannot join
- Cardiovascular diseases uncompensated
- uncompensated pleural diseases
- uncompensated liver diseases
- Recent surgeries less than 3 weeks
- malignancy receiving chemo and radiotherapy
- Recent exacerbations less than 3 months
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Phase 0 Study of Comparison Between Ground Walk Training and Treadmill Walk Training in COPD Patients
Pulmonary Rehabilitation became a vital part of management in COPD patients in form of activity modification, dietary and pharmacological optimisation. But access to traditional supervised aerobic (treadmill) walking is debatable fact due to economical and staffing expertise in developing countries like India. The investigators designed a randomised controlled trial to evaluate the effectiveness of ground based walking over traditional treadmill walking in improving quality of life in COPD patients.
Read the detailed description
Background: COPD is increasing mortality and morbidity globally. Pulmonary rehabilitation is a promising management in COPD management. Exercise training in form of aerobic (walking, cycling) and strength training is an important part of pulmonary rehabilitation. However access to traditional supervised exercise programs is questionable debate even in developed western countries. Unsupervised ground walk programs are often told by physicians but not properly prescribed.
Objective: To assess whether ground or treadmill walk is better in improving functional capacity and quality of life in COPD patients Design: Randomised controlled trial Procedure: Two arms 1) supervised ground walk training 2) supervised treadmill walk training. The intensity and progression of walk is based on 6 minute walk test. Quality of life will be gauged through Chronic respiratory questionnaire and functional capacity through 6 minute walk test.
Statistical analysis: Descriptive analysis for characterisation. Normality though Kolmogorov and Variables will be compared through paired and unpaired student t tests
- Being tested
- Ground walk training, Supervised Treadmill Walk training
- Keywords
- Ground walk, treadmill walk, Functional walk capacity, COPD, Quality of Life
- 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.
Ground walk trainingBehavioural
3 times a week and 6 weeks
Supervised Treadmill Walk trainingBehavioural
3 times a week and 6 weeks
| Study group | Role | What they receive |
|---|---|---|
| Supervised Treadmill Walk Training | Active comparator | Based on 6 minute walk distance, treadmill speed initiated and progression on basis new 6 minute walk distance every 2 weeks Receives: Behavioral: Supervised Treadmill Walk training |
| Supervised Ground walk training | Experimental | Ground walk training progressed on the basis of 6 minute walk distance (70 - 90%), Weekly 3 days and for 6 weeks Receives: Behavioral: Ground walk training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Functional Capacity (6 MINUTE WALK TEST)
6 minute walk test according to standardisation of ATS
Measured: Baseline, 6 weeks
Quality of Life (Chronic Respiratory Questionnaire)
CRQ - interviewer based
Measured: Baseline, 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Aug 2014 (estimated)
- Study startJul 2014
- Primary completionAug 2016
- Study completionOct 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Obstructive Pulmonary Disease (COPD)Studies 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
- Parallel groups
- Model description
- Treadmill training vs ground walk training
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- PSG Hospitals
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Baskaran Chandrasekaran, PSG Hospitals
- Investigators
- Baskaran Chandrasekaran, MPTh, Principal investigator, Senior Physiotherapist
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02218918
- Sponsor's protocol ID
- PSG01Rehab
- Acronym
- GWT/TWT
- Status last verified
- Oct 2017
- First submitted
- 11 Aug 2014
- Last updated
- 20 Oct 2017
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 20 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 0 Study of Comparison Between Ground Walk Training and Treadmill Walk Training in COPD Patients
- ClinicalTrials.gov ID
- NCT02218918
- Acronym / sponsor ID
- GWT/TWT / PSG01Rehab
- Keywords
- Ground walk, treadmill walk, Functional walk capacity, COPD, Quality of Life
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- PSG HospitalsUniversity, hospital or other
- Study start
- Jul 2014 (actual)
- Primary completion
- Aug 2016 (actual)
- Study completion
- Oct 2016 (actual)
- First posted
- 18 Aug 2014 (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.
Pulmonary Rehabilitation became a vital part of management in COPD patients in form of activity modification, dietary and pharmacological optimisation. But access to traditional supervised aerobic (treadmill) walking is debatable fact due to economical and staffing expertise in developing countries like India. The investigators designed a randomised controlled trial to evaluate the effectiveness of ground based walking over traditional treadmill walking in improving quality of life in COPD patients.
Detailed description
Background: COPD is increasing mortality and morbidity globally. Pulmonary rehabilitation is a promising management in COPD management. Exercise training in form of aerobic (walking, cycling) and strength training is an important part of pulmonary rehabilitation. However access to traditional supervised exercise programs is questionable debate even in developed western countries. Unsupervised ground walk programs are often told by physicians but not properly prescribed.
Objective: To assess whether ground or treadmill walk is better in improving functional capacity and quality of life in COPD patients Design: Randomised controlled trial Procedure: Two arms 1) supervised ground walk training 2) supervised treadmill walk training. The intensity and progression of walk is based on 6 minute walk test. Quality of life will be gauged through Chronic respiratory questionnaire and functional capacity through 6 minute walk test.
Statistical analysis: Descriptive analysis for characterisation. Normality though Kolmogorov and Variables will be compared through paired and unpaired student t tests
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Treadmill training vs ground walk training
| Arm | Type | Receives |
|---|---|---|
| Supervised Treadmill Walk Training | Active comparator | Behavioral: Supervised Treadmill Walk trainingBased on 6 minute walk distance, treadmill speed initiated and progression on basis new 6 minute walk distance every 2 weeks |
| Supervised Ground walk training | Experimental | Behavioral: Ground walk trainingGround walk training progressed on the basis of 6 minute walk distance (70 - 90%), Weekly 3 days and for 6 weeks |
Who may qualify
- Ages
- 40 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- stable COPD
- Stage II - IV
- Both genders
Key exclusion criteria (6 listed)
- Cardiovascular diseases uncompensated
- uncompensated pleural diseases
- uncompensated liver diseases
- Recent surgeries less than 3 weeks
- malignancy receiving chemo and radiotherapy
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 |
|---|---|---|
| Ground walk training3 times a week and 6 weeks | Behavioural | Supervised Ground walk training |
| Supervised Treadmill Walk training3 times a week and 6 weeks | Behavioural | Supervised Treadmill Walk Training |
Primary outcome
Functional Capacity (6 MINUTE WALK TEST)
Time frame: Baseline, 6 weeks
6 minute walk test according to standardisation of ATS
Quality of Life (Chronic Respiratory Questionnaire)
Time frame: Baseline, 6 weeks
CRQ - interviewer based
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Oct 2017.
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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.
Baskaran Chandrasekaran, MPTh principal investigator
Senior Physiotherapist
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ground walk training and Supervised Treadmill Walk training in people with Chronic Obstructive Pulmonary Disease (COPD), run by PSG Hospitals at 1 site in India.
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 6 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: finished, as of the sponsor's last update on 20 Oct 2017. 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 India. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Functional Capacity (6 MINUTE WALK TEST) (time frame: Baseline, 6 weeks). The study lists 2 primary outcomes in all. 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 20 Oct 2017.