| CTRI Number |
CTRI/2024/12/078746 [Registered on: 30/12/2024] Trial Registered Prospectively |
| Last Modified On: |
10/09/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA) |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Effect of Exercise on heart rate variability and sleep in patients with Chronic Obstructive Pulmonary Disease (COPD) |
|
Scientific Title of Study
|
Effect of Exercise on Heart Rate Variability, Cardiopulmonary Functions & Sleep Parameters in Indian COPD Patients |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Deepika Singla |
| Designation |
Assistant Professor |
| Affiliation |
Jamia Hamdard |
| Address |
Department of Physiotherapy
Jamia Hamdard
Mehrauli - Badarpur Rd,
near Batra Hospital,
Block D, Hamdard
Nagar, New Delhi
South
DELHI
110062
India |
| Phone |
8586976427 |
| Fax |
|
| Email |
dpkasingla@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Deepika Singla |
| Designation |
Assistant Professor |
| Affiliation |
Jamia Hamdard |
| Address |
Department of Physiotherapy
Jamia Hamdard
Mehrauli - Badarpur Rd,
near Batra Hospital,
Block D, Hamdard
Nagar, New Delhi
South
DELHI
110062
India |
| Phone |
8586976427 |
| Fax |
|
| Email |
dpkasingla@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Deepika Singla |
| Designation |
Assistant Professor |
| Affiliation |
Jamia Hamdard |
| Address |
Department of Physiotherapy
Jamia Hamdard
Mehrauli - Badarpur Rd,
near Batra Hospital,
Block D, Hamdard
Nagar, New Delhi
South
DELHI
110062
India |
| Phone |
8586976427 |
| Fax |
|
| Email |
dpkasingla@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
ICMR |
| Address |
Ansari Nagar, New Delhi - 110029 |
| Type of Sponsor |
Government funding agency |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Jamia Hamdard |
Hamdard Nagar, New 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 |
| Deepika Singla |
Jamia Hamdard |
Room N0. 501, 5th floor, Department of Physiotherapy, School of Nursing Sciences and Allied Health
South
DELHI |
8586976427
dpkasingla@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 |
control group |
Self-paced walking: 30 mins, 2-3 times/week
Breathing exercise: Deep breathing exercises, 2-3 times/week |
| Intervention |
Experimental group |
Endurance training (Cycle ergometer and treadmill walking): 20-60 min/session, 3-5 times/week
Resistance training (Leg press & Bench press): 8-12 RM, 2-3 days/week
Respiratory muscle training: 10-14 min/session, 2-3 times/week |
|
|
Inclusion Criteria
|
| Age From |
45.00 Year(s) |
| Age To |
75.00 Year(s) |
| Gender |
Both |
| Details |
Patients with COPD of at least 6 months duration
Clinical diagnosis of COPD according to the GOLD 1 (FEV 1 greater than or equal to 80%) and GOLD 2 (FEV 1 greater than or equal to 50% but less than 80%) criteria |
|
| ExclusionCriteria |
| Details |
Co-morbidities such as neurological diseases, musculoskeletal diseases, unstable cardiac disease, or cancer
Left ventricular EF less than 40%
Peripheral oxygen saturation less than 90% during the 6-minute walk test
DOE (dyspnea on exertion) and fatigue NYHA class 3: symptoms at mild exertion
Uncontrolled hypertension or diabetes
Psychiatric disorders such as anxiety or cognitive impairment
Need for regular oxygen therapy
Recent hospitalization
Exacerbation of the disease in the past month
Involved in regular physical activity
Participation in other rehabilitation, relaxation, and meditation programs, such as Yoga. |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
Heart Rate Variability
Cardiopulmonary functions
Sleep parameters |
On Day 1
After 8 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Body mass index
Fat mass/fat-free mass
Waist-to-hip ratio
Quality of life
Rating of perceived exertion
Hand grip strength
10 RM Bench press
10 RM Leg press |
On Day 1
After 8 weeks |
|
|
Target Sample Size
|
Total Sample Size="64"
Sample Size from India="64"
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)
|
02/01/2025 |
| 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="2"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Open to Recruitment |
| 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
|
People with chronic obstructive pulmonary disease (COPD) experience abnormality in heart rate variability, cardiopulmonary functions, and sleep. Early diagnosis and treatment are needed to slow the progression of symptoms and reduce flare-ups. The beneficial effect of exercise can be seen in patients with COPD. However, the impact of exercise training on heart rate variability, cardiopulmonary functions, and sleep parameters remains unclear. This research will focus on the exercise treatment protocol for patient with COPD and the effect of this exercise training on heart rate variability, cardiopulmonary functions & sleep parameters in patients with COPD. |