Clinical trial NCT02218918: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Obstructive Pulmonary Disease (COPD)
Keywords: Ground walk
treadmill walk
Functional walk capacity
COPD
Quality of Life
Lead sponsor: PSG Hospitals
Sponsor class: OTHER
First posted: 2014-08-18
Enrollment: 40
Sex: ALL
Minimum age (years): 40
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Treadmill training vs ground walk training
Primary purpose: TREATMENT

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

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

Primary outcomes:
measure: Functional Capacity (6 MINUTE WALK TEST)
timeFrame: Baseline, 6 weeks
measure: Quality of Life (Chronic Respiratory Questionnaire)
timeFrame: Baseline, 6 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Coimbatore
country: India
facility: PSG Hospitals
state: Tamilnadu
Study officials:
affiliation: Senior Physiotherapist
name: Baskaran Chandrasekaran, MPTh
role: PRINCIPAL_INVESTIGATOR
References: