Comparison of Supervised Ground Walk Training and Treadmill Walk Training in COPD Patients (GWT/TWT)
Primary Purpose
Chronic Obstructive Pulmonary Disease (COPD)
Status
Completed
Phase
Not Applicable
Locations
India
Study Type
Interventional
Intervention
Ground walk training
Supervised Treadmill Walk training
Sponsored by
About this trial
This is an interventional treatment trial for Chronic Obstructive Pulmonary Disease (COPD) focused on measuring Ground walk, treadmill walk, Functional walk capacity, COPD, Quality of Life
Eligibility Criteria
Inclusion Criteria:
- stable COPD
- Stage II - IV
- Both genders
Exclusion Criteria:
- 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
Sites / Locations
- PSG Hospitals
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
Supervised Treadmill Walk Training
Supervised Ground walk training
Arm Description
Based on 6 minute walk distance, treadmill speed initiated and progression on basis new 6 minute walk distance every 2 weeks
Ground walk training progressed on the basis of 6 minute walk distance (70 - 90%), Weekly 3 days and for 6 weeks
Outcomes
Primary Outcome Measures
Functional Capacity (6 MINUTE WALK TEST)
6 minute walk test according to standardisation of ATS
Quality of Life (Chronic Respiratory Questionnaire)
CRQ - interviewer based
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02218918
Brief Title
Comparison of Supervised Ground Walk Training and Treadmill Walk Training in COPD Patients
Acronym
GWT/TWT
Official Title
Phase 0 Study of Comparison Between Ground Walk Training and Treadmill Walk Training in COPD Patients
Study Type
Interventional
2. Study Status
Record Verification Date
October 2017
Overall Recruitment Status
Completed
Study Start Date
July 2014 (Actual)
Primary Completion Date
August 2016 (Actual)
Study Completion Date
October 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
PSG Hospitals
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief 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. 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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Obstructive Pulmonary Disease (COPD)
Keywords
Ground walk, treadmill walk, Functional walk capacity, COPD, Quality of Life
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Treadmill training vs ground walk training
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
40 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Supervised Treadmill Walk Training
Arm Type
Active Comparator
Arm Description
Based on 6 minute walk distance, treadmill speed initiated and progression on basis new 6 minute walk distance every 2 weeks
Arm Title
Supervised Ground walk training
Arm Type
Experimental
Arm Description
Ground walk training progressed on the basis of 6 minute walk distance (70 - 90%), Weekly 3 days and for 6 weeks
Intervention Type
Behavioral
Intervention Name(s)
Ground walk training
Intervention Description
3 times a week and 6 weeks
Intervention Type
Behavioral
Intervention Name(s)
Supervised Treadmill Walk training
Intervention Description
3 times a week and 6 weeks
Primary Outcome Measure Information:
Title
Functional Capacity (6 MINUTE WALK TEST)
Description
6 minute walk test according to standardisation of ATS
Time Frame
Baseline, 6 weeks
Title
Quality of Life (Chronic Respiratory Questionnaire)
Description
CRQ - interviewer based
Time Frame
Baseline, 6 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
stable COPD
Stage II - IV
Both genders
Exclusion Criteria:
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Baskaran Chandrasekaran, MPTh
Organizational Affiliation
Senior Physiotherapist
Official's Role
Principal Investigator
Facility Information:
Facility Name
PSG Hospitals
City
Coimbatore
State/Province
Tamilnadu
ZIP/Postal Code
641004
Country
India
12. IPD Sharing Statement
Learn more about this trial
Comparison of Supervised Ground Walk Training and Treadmill Walk Training in COPD Patients
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