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

October 19, 2017 updated by: Baskaran Chandrasekaran, PSG Hospitals

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Enrollment (Actual)

40

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • India
    • Tamilnadu
      • Coimbatore, Tamilnadu, India, 641004
        • PSG Hospitals

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

38 years to 68 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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
Behavioral: Supervised Treadmill Walk training
3 times a week and 6 weeks
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
Behavioral: Ground walk training
3 times a week and 6 weeks

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Functional Capacity (6 MINUTE WALK TEST)
Time Frame: Baseline, 6 weeks
6 minute walk test according to standardisation of ATS
Baseline, 6 weeks
Quality of Life (Chronic Respiratory Questionnaire)
Time Frame: Baseline, 6 weeks
CRQ - interviewer based
Baseline, 6 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

PSG Hospitals

Investigators

  • Principal Investigator: Baskaran Chandrasekaran, MPTh, Senior Physiotherapist

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 1, 2014

Primary Completion (Actual)

August 1, 2016

Study Completion (Actual)

October 1, 2016

Study Registration Dates

First Submitted

August 11, 2014

First Submitted That Met QC Criteria

August 14, 2014

First Posted (Estimate)

August 18, 2014

Study Record Updates

Last Update Posted (Actual)

October 20, 2017

Last Update Submitted That Met QC Criteria

October 19, 2017

Last Verified

October 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PSG01Rehab

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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