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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02218918
Other study ID # PSG01Rehab
Secondary ID
Status Completed
Phase N/A
First received August 11, 2014
Last updated October 19, 2017
Start date July 2014
Est. completion date October 2016

Study information

Verified date October 2017
Source PSG Hospitals
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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


Recruitment information / eligibility

Status Completed
Enrollment 40
Est. completion date October 2016
Est. primary completion date August 2016
Accepts healthy volunteers No
Gender All
Age group 40 Years to 70 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Behavioral:
Ground walk training
3 times a week and 6 weeks
Supervised Treadmill Walk training
3 times a week and 6 weeks

Locations

Country Name City State
India PSG Hospitals Coimbatore Tamilnadu

Sponsors (1)

Lead Sponsor Collaborator
PSG Hospitals

Country where clinical trial is conducted

India, 

Outcome

Type Measure Description Time frame Safety issue
Primary Functional Capacity (6 MINUTE WALK TEST) 6 minute walk test according to standardisation of ATS Baseline, 6 weeks
Primary Quality of Life (Chronic Respiratory Questionnaire) CRQ - interviewer based Baseline, 6 weeks
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