| CTRI Number |
CTRI/2025/04/083907 [Registered on: 02/04/2025] Trial Registered Prospectively |
| Last Modified On: |
02/04/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA) |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Comparing Ground Walk Training and Treadmill Training for improving Balance in Patients with COPD |
|
Scientific Title of Study
|
Effect of Ground Walk Training versus Treadmill Training in improving Static and Dynamic Balance, Endurance and Quality of Life in Patients with COPD:A Randomized Controlled Trial |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Gayatri Goel |
| Designation |
PG Student (MPT Cardiopulmonary) |
| Affiliation |
Jamia Hamdard, New Delhi-110062 |
| Address |
Department of Physiotherapy, SNSAH, Jamia Hamdard, Mehrauli - Badarpur Rd, near Batra Hospital, Block D, Hamdard Nagar, New Delhi, Delhi 110062
South
DELHI
110062
India |
| Phone |
7088954601 |
| Fax |
|
| Email |
gayatrigoel08@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Jyoti Ganai PT |
| Designation |
Assistant Professor |
| Affiliation |
Jamia Hamdard, New Delhi |
| Address |
Department of Physiotherapy, SNSAH, Jamia Hamdard, Mehrauli - Badarpur Rd, near Batra Hospital, Block D, Hamdard Nagar, New Delhi, Delhi 110062
South
DELHI
110062
India |
| Phone |
9818379267 |
| Fax |
|
| Email |
jyotiganai@jamiahamdard.ac.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Jyoti Ganai PT |
| Designation |
Assistant Professor |
| Affiliation |
Jamia Hamdard, New Delhi |
| Address |
Department of Physiotherapy, SNSAH, Jamia Hamdard, Mehrauli - Badarpur Rd, near Batra Hospital, Block D, Hamdard Nagar, New Delhi, Delhi 110062
South
DELHI
110062
India |
| Phone |
9818379267 |
| Fax |
|
| Email |
jyotiganai@jamiahamdard.ac.in |
|
|
Source of Monetary or Material Support
|
| JAMIA HAMDARD, Rehabilitation Centre, Gate No. 6, Hamdard Nagar, New Delhi, Delhi 110062 |
|
|
Primary Sponsor
|
| Name |
Gayatri Goel |
| Address |
Department of Physiotherapy, SNSAH, Jamia Hamdard, Mehrauli-Badarpur Rd, near Batra Hospital, Block D, Hamdard Nagar, New Delhi, Delhi 110062 |
| Type of Sponsor |
Other [NIL] |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Dr Jyoti Ganai PT |
Department of Physiotherapy, SNSAH, Jamia Hamdard, Mehrauli-Badarpur Rd, near Batra Hospital, Block D, Hamdard Nagar, New Delhi, Delhi 110062 |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Jyoti Ganai PT |
Rehabilitation Centre, Jamia Hamdard |
Room No.9, Rehabilitation Centre, Gate No. 6, Mehrauli - Badarpur Rd, near Batra Hospital, Block D, Hamdard Nagar, New Delhi, Delhi 110062
South
DELHI |
9818379267
gayatrigoel08@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| JAMIA HAMDARD INSTITUTIONAL ETHICS COMMITTEE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: J449||Chronic obstructive pulmonary disease, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
GROUND WALK TRAINING |
Ground Walk Training performed for the duration of 30 minutes daily for 24 sessions with the speed set at 80% of average speed achieved during the 6-Minute Walk Test |
| Intervention |
TREADMILL TRAINING |
Treadmill Training using Naughton Protocol for 24 sessions |
|
|
Inclusion Criteria
|
| Age From |
40.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
COPD (Stage 1 -2 GOLD classification)
|
|
| ExclusionCriteria |
| Details |
Acute exacerbation of COPD, Significant co-morbidities including cardiovascular disease, malignancy systematic disorders, physical limitations such as orthopedic impairments and patients with walking aid, Unstable vital signs, Recent hospitalization |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Alternation |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
Static balance
Dynamic balance
6 Minute Walk Distance Test
SGRQ- St. George Respiratory Questionnaire |
24 sessions in 4 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
BRPE Score
VO2 MAX |
24 sessions in 4 weeks |
|
|
Target Sample Size
|
Total Sample Size="44"
Sample Size from India="44"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
15/04/2025 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
This is a randomized, blinded, parallel group trial to compare the effect of GWT (Ground Walk Training) versus TMT (Treadmill Training) in improving static and dynamic balance, endurance and quality of life among patients with COPD. |