| CTRI Number |
CTRI/2024/04/065385 [Registered on: 08/04/2024] Trial Registered Prospectively |
| Last Modified On: |
29/03/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA) |
| Study Design |
Randomized, Parallel Group, Multiple Arm Trial |
|
Public Title of Study
|
Development of Structural Exercise program in patients with Parkinson’s disease |
|
Scientific Title of Study
|
Optimization and Efficacy of Exercise Protocols in patients suffering from Parkinson’s disease |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Sakshi Jangra |
| Designation |
Ph.D. Scholar |
| Affiliation |
Guru Jambheshwar University of Science and Technology, Hisar Haryana 125001 India |
| Address |
Department of Physiotherapy, Guru Jambheshwar University of Science and Technology, Hisar
Haryana
125001
India
Hisar
HARYANA
125001
India |
| Phone |
7357620699 |
| Fax |
|
| Email |
sakshijangra555@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Prof Jaspreet Kaur |
| Designation |
Professor, Department of Physiotherapy |
| Affiliation |
Guru Jambheshwar University of Science and Technology, Hisar Haryana 125001 India |
| Address |
Department of Physiotherapy, Guru Jambheshwar University of Science and Technology, Hisar
Haryana
125001
India
Hisar
HARYANA
125001
India |
| Phone |
9466092657 |
| Fax |
|
| Email |
jaspreet248103@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Prof Jaspreet Kaur |
| Designation |
Professor, Department of Physiotherapy |
| Affiliation |
Guru Jambheshwar University of Science and Technology, Hisar Haryana 125001 India |
| Address |
Department of Physiotherapy, Guru Jambheshwar University of Science and Technology, Hisar
Haryana
125001
India
HARYANA
125001
India |
| Phone |
9466092657 |
| Fax |
|
| Email |
jaspreet248103@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Physiotherapy, Guru Jambheshwar University of Science and Technology, Hisar, Haryana, India, Pin code 125001 |
|
|
Primary Sponsor
|
| Name |
Sakshi Jangra |
| Address |
Department of Physiotherapy, Guru Jambheshwar University of Science and Technology, Hisar, Haryana, India, Pin code 125001 |
| Type of Sponsor |
Other [Self] |
|
|
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 Sakshi Jangra PT |
Guru Jambheshwar University of Science and Technology |
Room No. 109, Research lab, Department of Physiotherapy, Guru Jambheshwar University of Science and Technology, Hisar, Haryana
Hisar
HARYANA |
7357620699
sakshijangra555@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Committee Department of Physiotherapy GJUST Hisar |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: G20||Parkinsons disease, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
GROUP 1 |
Participants in this group will do Aerobic exercise with auditory cueing, Progressive resistance exercises, Balance training with auditory cueing with 3 repetitions of each exercise, conducted twice a week for 6 weeks. |
| Intervention |
GROUP 2 |
This group will follow the same exercises as Group 1 but will perform 5 repetitions of each exercise, twice a week for 6 weeks. |
| Intervention |
GROUP 3 |
This group will follow the same exercises as Group 1 but will perform 7 repetitions of each exercise, twice a week for 6 weeks. |
| Intervention |
GROUP 4 |
This group will follow the same exercises as Group 1 but will perform 3 repetitions of each exercise, thrice a week for 6 weeks. |
| Intervention |
GROUP 5 |
This group will follow the same exercises as Group 1 but will perform 5 repetitions of each exercise, thrice a week for 6 weeks. |
| Intervention |
GROUP 6 |
This group will follow the same exercises as Group 1 but will perform 7 repetitions of each exercise, thrice a week for 6 weeks. |
| Intervention |
GROUP 7 |
This group will follow the same exercises as Group 1 but will perform 3 repetitions of each exercise, five times weekly for 6 weeks. |
| Intervention |
GROUP 8 |
This group will follow the same exercises as Group 1 but will perform 5 repetitions of each exercise, five times weekly for 6 weeks. |
| Intervention |
GROUP 9 |
This group will follow the same exercises as Group 1 but will perform 7 repetitions of each exercise, five times weekly for 6 weeks. |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
40.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
1. Patients of Idiopathic Parkinson Disease diagnosed with United Kingdom Parkinson’s Disease Society Brain Bank Clinical Diagnostic Criteria
2. Hoehn & Yahr stage 1-3
3. Lack of dementia |
|
| ExclusionCriteria |
| Details |
1. Presence of cardiovascular, pulmonary, orthopaedic or other medical conditions that limit the data collection.
2. Severe cognitive impairment.
3. Major psychological illness.
4. Prostheses in the lower limbs. |
|
|
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 Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
1. Fullerton Advanced Balance Scale (FAB)
2. Stride Length
3. Step Length
4. Cadence
5. New Freezing of Gait Questionnaire (NFOG-Q)
6. Parkinson Anxiety Scale (PAS)
|
Baseline
6 weeks
Follow up
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Forced Vital Capacity (FVC) |
Baseline
6 weeks
Follow up |
| Forced Expiratory Volume in 1 second (FEV1) |
Baseline
6 weeks
Follow up |
| Peak Expiratory flow (PEF) |
Baseline
6 weeks
Follow up |
| FEV1/FVC (%) |
Baseline
6 weeks
Follow up |
| Hamilton depression rating scale (HAM-D) |
Baseline
6 weeks
Follow up |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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 1 |
|
Date of First Enrollment (India)
|
20/04/2024 |
| 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)
|
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 aim of this study is to optimize and find efficacy of the exercise protocols on various parameters (balance, gait, respiratory function and psychological parameters) based on two factors that is frequency and repetitions in patients with Parkinson’s disease. Patients with Parkinson’s disease will be selected from various hospitals of Hisar. Patients will be screened on the basis of selection criteria. Whole experimental procedure will be explained and informed consent will be obtained from participants prior to commencement of the study. Participants will be randomly assigned into 9 groups. Pre, Post and Follow up data will be obtained from the participants. The duration of the intervention will be 6 weeks. |