| CTRI Number |
CTRI/2025/03/081954 [Registered on: 07/03/2025] Trial Registered Prospectively |
| Last Modified On: |
23/01/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA) |
| Study Design |
Non-randomized, Active Controlled Trial |
|
Public Title of Study
|
Effect of Treadmill Exercise on stroke Patients Anxiety, Depression, and Quality of Life. |
|
Scientific Title of Study
|
Effectiveness of Treadmill-based Aerobic Exercise on Anxiety, Depression and Quality of Life in Patients with Post-stroke: An Experimental Study |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Pratik Bhagwan Dhumal |
| Designation |
Masters of Neurophysiotherapy Student |
| Affiliation |
Maharashtra Institute of Physiotherapy, Latur |
| Address |
Department of Neurophysiotherapy, OPD-16, Maharashtra Institute of Physiotherapy, MIMSR medical campus, Ambajogai Road, Latur
Latur
MAHARASHTRA
513531
India |
| Phone |
9420034283 |
| Fax |
|
| Email |
pbdhumal2000@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Neha Singh Mandade |
| Designation |
Professor Of Neurophysiotherapy Department |
| Affiliation |
Maharashtra Institute of Physiotherapy, Latur |
| Address |
Department of Neurophysiotherapy, OPD-16, Maharashtra Institute of Physiotherapy, MIMSR medical campus, Ambajogai Road, Latur
Latur
MAHARASHTRA
413531
India |
| Phone |
797250020 |
| Fax |
|
| Email |
drneha9559@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Neha Singh Mandade |
| Designation |
Professor Of Neurophysiotherapy Department |
| Affiliation |
Maharashtra Institute of Physiotherapy, Latur |
| Address |
Department of Neurophysiotherapy, OPD-16, Maharashtra Institute of Physiotherapy, MIMSR medical campus, Ambajogai Road, Latur
Latur
MAHARASHTRA
413531
India |
| Phone |
797250020 |
| Fax |
|
| Email |
drneha9559@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Neuro-physiotherapy, OPD-16, Maharashtra Institute Of Physiotherapy, Latur, Maharashtra 413531 India |
|
|
Primary Sponsor
|
| Name |
Maharashtra Institute of Physiotherapy, Latur |
| Address |
Maharashtra Institute Of Physiotherapy, MIMSR Medical campus, Ambajogai Road, Latur
413531 |
| Type of Sponsor |
Research institution and hospital |
|
|
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 Pratik Bhagwan Dhumal |
Maharshtra Institute Of Physiotherapy, Latur |
Department of Neurophysiotherapy, OPD-16, MIMSR medical campus, Ambajogai Road, Latur
Latur
MAHARASHTRA |
9420034283
pbdhumal2000@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Ethics Comittee for Research on Human Subjects |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: F411||Generalized anxiety disorder, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
NIL |
NIL |
| Intervention |
Treadmill-based Aerobic Exercise |
The patients performed 24 sessions with 48-72 hours of the interval between each one. They received information about the training procedures and were encouraged to work until the end of the set time, but advised that they could also abort the training session to signal complications or fatigue. (5)
The intensity settings decided at 45-50% of HRR for warm-up, 50-55% of HRR for training and 45-50% of HRR for cool-down. The warm-up and cool-down were performed for 5 minutes respectively and aerobic training was performed for 20 minutes, totalizing 30 minutes, for 3 times/week (8 weeks) (5)
Target/training heart rate can be calculated by the Karvonen formula.
220-age = max. heart rate
RHR = heart rate at rest
HRR = HRmax – RHR
Target HR = RHR (Intensity. HRR)
|
|
|
Inclusion Criteria
|
| Age From |
50.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
1.Subacute and Chronic stroke patients.
2.Age group of 50 to 70 years of both genders.
3.Score of Hospital anxiety and depression scale examination less than 10
4.Lower Score On examination of stroke-specific Quality of life scale.
5.Patient with MMSE score less than or equal to 24
6.Patient with berg balance scale score less than or equal to 21
|
|
| ExclusionCriteria |
| Details |
1.Any other associated neurological disorder.
2.Severe perceptual and visual defects.
3.Recent History of myocardial infarction, and coronary artery bypass.
4.Any psychological disorders.
5.Patients not willing to participate in the study.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
1. Hospital Anxiety and Depression scale
2.The stroke-specific Quality of life Scale
|
1.Hospital Anxiety and Depression scale more than 8
2.The stroke-specific Quality of life Scale score will be lower
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. Mini-Mental Status Examination
2.Berg balance scale |
1. MMSE score more than or equal to 24
2.Berg balance scale score more than equal to 21
|
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
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)
|
21/03/2025 |
| 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 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
|
The study procedure will start after approval from the Institutional Ethical Committee. Patients will be screened according to inclusion and exclusion criteria and eligible patients will be included in the study. Before collection of the data, patients will be explained about the study and procedure in detail and informed written consent will be obtained from the patients. The patients will be interviewed and information will be gathered using data collection sheet. The Pre-exercise data will be obtained using the Hospital Anxiety (HADS) and Depression scale and the stroke-specific Quality of life Scale (SS-QOL) The intervention will be given for 3 days/week for 8 weeks, i.e. 24 sessions. The intervention will include a 30-minute aerobic exercise. Warm-up and cool-down exercise for 5 minutes each & treadmill training for 20 minutes. After the 12 sessions, again post-exercise data will be obtained at the end of 4 weeks by using HADS and SS-QOL. And then again after 24 sessions, post-exercise data will be obtained at the end of 8 weeks. |