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

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.

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

Study Design

• 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

Arms and Interventions

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

Outcome Measures

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

Eligibility Criteria

• 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

Contacts and Locations

Locations

India

PSG Hospitals

Coimbatore, Tamilnadu, India, 641004

Sponsors and Collaborators

PSG Hospitals

Investigators

• Principal Investigator: Baskaran Chandrasekaran, MPTh; Senior Physiotherapist

More Information

• Responsible Party: Baskaran Chandrasekaran, Senior Physiotherapist, PSG Hospitals
• ClinicalTrials.gov Identifier: NCT02218918
• Other Study ID Numbers: PSG01Rehab
• First Posted: August 18, 2014
• 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:

Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive; Lung Diseases; Respiratory Tract Diseases