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

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

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.

Condition or disease Intervention/treatment Phase
Chronic Obstructive Pulmonary Disease (COPD) Behavioral: Ground walk training Behavioral: Supervised Treadmill Walk training Not Applicable

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

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Treadmill training vs ground walk training
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Phase 0 Study of Comparison Between Ground Walk Training and Treadmill Walk Training in COPD Patients
Actual Study Start Date : July 2014
Actual Primary Completion Date : August 2016
Actual Study Completion Date : October 2016

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




Primary Outcome Measures :
  1. Functional Capacity (6 MINUTE WALK TEST) [ Time Frame: Baseline, 6 weeks ]
    6 minute walk test according to standardisation of ATS

  2. Quality of Life (Chronic Respiratory Questionnaire) [ Time Frame: Baseline, 6 weeks ]
    CRQ - interviewer based



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Ages Eligible for Study:   40 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02218918


Locations
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India
PSG Hospitals
Coimbatore, Tamilnadu, India, 641004
Sponsors and Collaborators
PSG Hospitals
Investigators
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Principal Investigator: Baskaran Chandrasekaran, MPTh Senior Physiotherapist
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Responsible Party: Baskaran Chandrasekaran, Senior Physiotherapist, PSG Hospitals
ClinicalTrials.gov Identifier: NCT02218918    
Other Study ID Numbers: PSG01Rehab
First Posted: August 18, 2014    Key Record Dates
Last Update Posted: October 20, 2017
Last Verified: October 2017
Keywords provided by Baskaran Chandrasekaran, PSG Hospitals:
Ground walk
treadmill walk
Functional walk capacity
COPD
Quality of Life
Additional relevant MeSH terms:
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Lung Diseases, Obstructive
Pulmonary Disease, Chronic Obstructive
Lung Diseases
Respiratory Tract Diseases