NCT02218918

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jul 2014

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2014

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

August 11, 2014

Completed
7 days until next milestone

First Posted

Study publicly available on registry

August 18, 2014

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2016

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2016

Completed
Last Updated

October 20, 2017

Status Verified

October 1, 2017

Enrollment Period

2.1 years

First QC Date

August 11, 2014

Last Update Submit

October 19, 2017

Conditions

Chronic Obstructive Pulmonary Disease (COPD)

Keywords

Ground walktreadmill walkFunctional walk capacityCOPDQuality of Life

Outcome Measures

Primary Outcomes (2)

  • Functional Capacity (6 MINUTE WALK TEST)

    6 minute walk test according to standardisation of ATS

    Baseline, 6 weeks

  • Quality of Life (Chronic Respiratory Questionnaire)

    CRQ - interviewer based

    Baseline, 6 weeks

Study Arms (2)

Supervised Treadmill Walk Training

ACTIVE COMPARATOR

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

Supervised Ground walk training

EXPERIMENTAL

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

Interventions

Ground walk trainingBEHAVIORAL

3 times a week and 6 weeks

Supervised Ground walk training
Supervised Treadmill Walk trainingBEHAVIORAL

3 times a week and 6 weeks

Supervised Treadmill Walk Training

Eligibility Criteria

Age40 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • stable COPD
  • Stage II - IV
  • Both genders

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

PSG Hospitals

Coimbatore, Tamil Nadu, 641004, India

Location

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Condition Hierarchy (Ancestors)

Lung Diseases, ObstructiveLung DiseasesRespiratory Tract DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Baskaran Chandrasekaran, MPTh

    Senior Physiotherapist

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Treadmill training vs ground walk training
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Senior Physiotherapist

Study Record Dates

First Submitted

August 11, 2014

First Posted

August 18, 2014

Study Start

July 1, 2014

Primary Completion

August 1, 2016

Study Completion

October 1, 2016

Last Updated

October 20, 2017

Record last verified: 2017-10

Locations

IN(1)