Comparison of Supervised Ground Walk Training and Treadmill Walk Training in COPD Patients (GWT/TWT)

• ClinicalTrials.gov Identifier: NCT02218918
• Recruitment Status: Completed
• First Posted: August 18, 2014
• Last Update Posted: October 20, 2017
• Sponsor: PSG Hospitals
• Information provided by (Responsible Party): Baskaran Chandrasekaran, PSG Hospitals

Tracking Information

• First Submitted Date: August 11, 2014
• First Posted Date: August 18, 2014
• Last Update Posted Date: October 20, 2017
• Actual Study Start Date: July 2014
• Actual Primary Completion Date: August 2016 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: October 19, 2017)

• 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

Original Primary Outcome Measures (submitted: August 14, 2014)

• Functional Capacity (6 MINUTE WALK TEST) [ Time Frame: Baseline, 6 weeks ]
• Quality of Life (Chronic Respiratory Questionnaire) [ Time Frame: Baseline, 6 weeks ]

• Current Secondary Outcome Measures: Not Provided
• Original Secondary Outcome Measures: Not Provided
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Comparison of Supervised Ground Walk Training and Treadmill Walk Training in COPD Patients
• Official Title: Phase 0 Study of Comparison Between Ground Walk Training and Treadmill Walk Training in COPD Patients
• 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

• Study Type: Interventional
• Study Phase: Not Applicable

Study Design

Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:

Treadmill training vs ground walk training

Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment

• Condition: Chronic Obstructive Pulmonary Disease (COPD)

Intervention

• Behavioral: Ground walk training
  3 times a week and 6 weeks
• Behavioral: Supervised Treadmill Walk training
  3 times a week and 6 weeks

Study Arms

• Active Comparator: Supervised Treadmill Walk Training
  Based on 6 minute walk distance, treadmill speed initiated and progression on basis new 6 minute walk distance every 2 weeks
  Intervention: Behavioral: Supervised Treadmill Walk training
• Experimental: Supervised Ground walk training
  Ground walk training progressed on the basis of 6 minute walk distance (70 - 90%), Weekly 3 days and for 6 weeks
  Intervention: Behavioral: Ground walk training

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: August 14, 2014): 40
• Original Estimated Enrollment: Same as current
• Actual Study Completion Date: October 2016
• Actual Primary Completion Date: August 2016 (Final data collection date for primary outcome measure)

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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 40 Years to 70 Years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: India

Administrative Information

• NCT Number: NCT02218918
• Other Study ID Numbers: PSG01Rehab
• Has Data Monitoring Committee: Yes
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Responsible Party: Baskaran Chandrasekaran, PSG Hospitals
• Study Sponsor: PSG Hospitals
• Collaborators: Not Provided

Investigators

• Principal Investigator: Baskaran Chandrasekaran, MPTh; Senior Physiotherapist

• PRS Account: PSG Hospitals
• Verification Date: October 2017