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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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

Tracking Information
First Submitted Date  ICMJE August 11, 2014
First Posted Date  ICMJE August 18, 2014
Last Update Posted Date October 20, 2017
Actual Study Start Date  ICMJE July 2014
Actual Primary Completion Date August 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (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  ICMJE
 (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 ]
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Comparison of Supervised Ground Walk Training and Treadmill Walk Training in COPD Patients
Official Title  ICMJE 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  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:
Treadmill training vs ground walk training
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Chronic Obstructive Pulmonary Disease (COPD)
Intervention  ICMJE
  • 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  ICMJE
  • 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

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: August 14, 2014)
40
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE October 2016
Actual Primary Completion Date August 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 40 Years to 70 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE India
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02218918
Other Study ID Numbers  ICMJE PSG01Rehab
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Baskaran Chandrasekaran, PSG Hospitals
Study Sponsor  ICMJE PSG Hospitals
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Baskaran Chandrasekaran, MPTh Senior Physiotherapist
PRS Account PSG Hospitals
Verification Date October 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP