| CTRI Number |
CTRI/2025/10/096416 [Registered on: 23/10/2025] Trial Registered Prospectively |
| Last Modified On: |
22/10/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA) |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Effect of high-intensity interval training on heart rate, fitness, body composition, and quality of life in stroke survivors. |
|
Scientific Title of Study
|
Effect of High Intensity Interval Training on Resting Heart Rate, Heart Rate Recovery, Functional Capacity, Body Composition and Quality of Life in Stroke Survivors. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Saima Zaki |
| Designation |
Assistant Professor |
| Affiliation |
Sharda University |
| Address |
Department of Physiotherapy Sharda School of Allied Health Sciences Sharda University
Gautam Buddha Nagar
UTTAR PRADESH
201310
India |
| Phone |
9990648665 |
| Fax |
|
| Email |
saima.zaki@sharda.ac.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Saima Zaki |
| Designation |
Assistant Professor |
| Affiliation |
Sharda University |
| Address |
Department of Physiotherapy Sharda School of Allied Health Sciences Sharda University
Gautam Buddha Nagar
UTTAR PRADESH
201310
India |
| Phone |
9990648665 |
| Fax |
|
| Email |
saima.zaki@sharda.ac.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Saima Zaki |
| Designation |
Assistant Professor |
| Affiliation |
Sharda University |
| Address |
Department of Physiotherapy Sharda School of Allied Health Sciences Sharda University
Gautam Buddha Nagar
UTTAR PRADESH
201310
India |
| Phone |
9990648665 |
| Fax |
|
| Email |
saima.zaki@sharda.ac.in |
|
|
Source of Monetary or Material Support
|
| Department of Physiotherapy, Sharda School of Allied Health Sciences, Sharda Hospital, Sharda University, Plot No. 32-34, Knowledge Park III, Greater Noida, Uttar Pradesh 201310 |
|
|
Primary Sponsor
|
| Name |
Sharda University |
| Address |
Sharda School of Allied Health Sciences Sharda University Knowledge Park III Greater Noida, Uttar Pradesh India – 201310 |
| Type of Sponsor |
Other [Academics] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Lailat Juma Sharif |
Sharda Hospital |
Department of Physiotherapy Block-F OPD
Gautam Buddha Nagar
UTTAR PRADESH |
9266319808
shariflailat@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Commitee School of Medical Sciences and Research and Sharda Hospital |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: I699||Sequelae of unspecified cerebrovascular diseases, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Control |
Participants in the control group will continue to receive standard post-stroke care as prescribed by their attending physician. This will include routine medical management, usual physiotherapy or mobility advice, and general rehabilitation guidance, without any additional structured exercise or supervised aerobic training.
No formal exercise intervention, counseling, or follow-up between assessments will be provided beyond standard clinical care. The purpose of this comparator is to evaluate the added benefit of HIIT over routine rehabilitation. |
| Intervention |
High Intensity Interval Training |
Participants in the intervention group will undergo a treadmill-based high intensity interval training (HIIT) program under the supervision of a qualified physiotherapist. Training will be conducted three sessions per week for four weeks, each session lasting approximately 25–30 minutes, including warm-up and cool-down phases.
Each HIIT session will consist of alternating periods of high-intensity walking (at an exertion level of RPE 14–16 on the Borg 6–20 scale, corresponding to “hard” intensity) and active recovery (RPE 9–11).
Week 1–2: 30 sec high intensity : 60 sec recovery
Week 3: 45 sec high intensity : 45 sec recovery
Week 4: 60 sec high intensity : 30 sec recovery
Vital signs including heart rate, blood pressure, oxygen saturation, and rate of perceived exertion (RPE) will be monitored before, during, and after each session.
Safety measures include physician clearance prior to participation, on-site emergency equipment (oxygen supply and defibrillator), and continuous supervision by a trained physiotherapist.
The intervention aims to improve resting heart rate, heart rate recovery, functional capacity (6MWT), body composition, and quality of life (SF-36) in stroke survivors. |
|
|
Inclusion Criteria
|
| Age From |
40.00 Year(s) |
| Age To |
75.00 Year(s) |
| Gender |
Both |
| Details |
Stroke survivors aged 40 to 75 years.
Medically stable with vital signs within acceptable range and cleared by a physician for participation in exercise.
In the subacute or chronic phase of stroke recovery (at least three months post stroke).
Able to walk independently or with a walking aid for at least ten meters
Not enrolled in any structured exercise program during the past twelve months.
Able to understand and follow simple instructions (Mini Mental State Examination score more than 24 if applicable).
Provided written informed consent.
Passed pre exercise cardiovascular screening (resting heart rate less than 100 beats per minute and resting blood pressure less than 160 over 100 millimetres of mercury). |
|
| ExclusionCriteria |
| Details |
Cognitive impairment or inability to provide informed consent.
Clinically unstable patients such as those with fluctuating blood pressure, active infection, or unstable neurological status.
History of fainting or loss of consciousness during exertion in the past twelve months.
Recent myocardial infarction, unstable angina, or cardiac surgery within the past three months.
Uncontrolled high blood pressure at rest defined as systolic blood pressure 160 millimetres of mercury or more and or diastolic blood pressure 100 millimetres of mercury or more.
Severe heart or lung disease such as decompensated heart failure, severe chronic obstructive pulmonary disease, or unstable arrhythmias.
Severe orthopedic or neurological problems that prevent safe exercise, such as non weight bearing fractures or severe spasticity.
Severe psychiatric illness that interferes with participation.
Pregnancy.
Any other condition considered unsafe for high intensity exercise by the physiotherapist or physician. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
Resting heart rate
Heart rate recovery after exercise
Functional capacity measured using six-minute walk test |
Baseline (before intervention)
After four weeks of intervention |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Body composition measured by standard methods
Health related quality of life |
Baseline (before intervention)
After four weeks of intervention |
|
|
Target Sample Size
|
Total Sample Size="32"
Sample Size from India="32"
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
|
Phase 2/ Phase 3 |
|
Date of First Enrollment (India)
|
15/11/2025 |
| 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="0"
Months="3"
Days="10" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
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
|
Stroke often leads to reduced cardiovascular fitness, slower recovery after activity, poor physical capacity, and decline in quality of life. Exercise is known to support recovery after stroke, but the role of high intensity interval training has not been studied widely in Indian stroke survivors. This randomized controlled trial aims to examine the effects of a four week program of treadmill based high intensity interval training on cardiovascular and functional outcomes in stroke survivors. A total of 32 participants aged 40 to 75 years will be randomly assigned into two groups. The intervention group will undergo supervised high intensity interval training three times per week for four weeks, while the control group will receive standard care without additional structured exercise. The primary outcomes are resting heart rate, heart rate recovery after exercise, and functional capacity measured using the six minute walk test. The secondary outcomes are body composition measured by standard anthropometric methods and health related quality of life assessed. Assessments will be done at baseline and after four weeks. This trial is expected to provide evidence on the safety and effectiveness of high intensity interval training for improving cardiovascular health, functional recovery, and overall well being in people recovering from stroke. |