| CTRI Number |
CTRI/2025/04/084832 [Registered on: 15/04/2025] Trial Registered Prospectively |
| Last Modified On: |
15/04/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA) |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Strength Training in Parkinsons Disease |
|
Scientific Title of Study
|
Strength Training as an Add-on to Standard Pharmacotherapy in Patients with Parkinsons Disease: A Randomized Controlled Biomarker Trial (SToP-PD) |
| Trial Acronym |
SToP-PD |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| I-NK/NEUROLOGY/SToP-PD/2024 Ver.01 Dated October 28, 2024 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Supriyo Choudhury |
| Designation |
Assistant Director of Research |
| Affiliation |
Institute of Neurosciences Kolkata |
| Address |
Institute of Neurosciences Kolkata, 9th floor, Department of Neurology, Research room, 185/1, AJC Bose Road, Kolkata 700017
Kolkata
WEST BENGAL
700017
India |
| Phone |
9433106238 |
| Fax |
|
| Email |
choudhurydrsupriyo@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Supriyo Choudhury |
| Designation |
Assistant Director of Research |
| Affiliation |
Institute of Neurosciences Kolkata |
| Address |
Institute of Neurosciences Kolkata, 9th floor, Department of Neurology, Research room, 185/1, AJC Bose Road, Kolkata 700017
Kolkata
WEST BENGAL
700017
India |
| Phone |
9433106238 |
| Fax |
|
| Email |
choudhurydrsupriyo@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Supriyo Choudhury |
| Designation |
Assistant Director of Research |
| Affiliation |
Institute of Neurosciences Kolkata |
| Address |
Institute of Neurosciences Kolkata, 9th floor, Department of Neurology, Research room, 185/1, AJC Bose Road, Kolkata 700017
Kolkata
WEST BENGAL
700017
India |
| Phone |
9433106238 |
| Fax |
|
| Email |
choudhurydrsupriyo@gmail.com |
|
|
Source of Monetary or Material Support
|
| Institute of Neurosciences Kolkata, 185/1, AJC Bose Road, Kolkata 700017 |
|
|
Primary Sponsor
|
| Name |
Indian Council of Medical Research(ICMR) |
| Address |
V. Ramalingaswami Bhawan, P.O. Box No. 4911 Ansari Nagar, New
Delhi - 110029, India |
| Type of Sponsor |
Government funding agency |
|
|
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 Supriyo Choudhury |
Institute of Neurosciences Kolkata |
Institute of Neurosciences Kolkata, 9th floor, Department of Neurology, Research room, 185/1, AJC Bose Road, Kolkata 700017
Kolkata
WEST BENGAL |
9433106238
choudhurydrsupriyo@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| IEC, Institute of Neurosciences Kolkata |
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 |
| Comparator Agent |
Standard of care |
Standard Pharmacotherapy for Parkinsons Disease |
| Intervention |
Strength training |
The intervention will be a total of 12 weeks long, where participants will be trained by an experienced physiotherapist on the date of screening and on Day2. The training sessions will be AV recorded in patients’ mobile camera, for future reference. The patients will perform assisted (by caregiver) home-based training three days a week (every alternate day with Sunday off). The patients will be requested to come once every fortnight for an hour-long session for monitoring of muscle strength and progressive increase in resistance (when needed).The patients on ST group will be prescribed three sets of 8 repetitions at 60-70% of their one repetition maximum (1-RM), as determined during their pre-test(6). Knee extension, hip flexion, foot dorsiflexion, biceps curl, power grip, and lateral raise exercises etc. will be advised for the training using inexpensive free weights like adjustable leg and wrist weighted bands. A warmup and cool down period will be taught to initiate and conclude the training sessions respectively. The duration of the session should remain between 30 mins to one hour. |
|
|
Inclusion Criteria
|
| Age From |
40.00 Year(s) |
| Age To |
75.00 Year(s) |
| Gender |
Both |
| Details |
Individuals diagnosed with Idiopathic Parkinsons disease according to MDS clinical diagnostic criteria. Patients of either sex between the age of 40 to 75 years and Hoehn and Yahr stages 1 to 3 who can stand unassisted for two minutes and having a clinically apparent gait problem will be included in the study. Patients will require access to smartphone for AV recording and viewing the training program. Patient must have a study partner who will assist him/ her in the domiciliary training sessions. |
|
| ExclusionCriteria |
| Details |
PD patients with dyskinesia will not be enrolled. Patients with significant musculoskeletal problems or chronic pain, which might be aggravated by training or interfere with the outcome as perceived by the PI/ Co-I, will be excluded. Patients with a neurological disease other than PD or other physical impairments that would prevent participation in the muscular strength testing will be excluded on screening. PD patients with uncontrolled systemic diseases (e.g. hypertension, heart diseases, etc.) or significant cognitive impairment or refractory psychiatric symptoms will also be excluded, as will those who are already participating in a structured exercise program (including yoga, regular supervised/unsupervised stretching, or aerobic training). However, those who walk for their fitness regularly, may be included in the study. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Comparison of changes in muscle strength, motor function and cognition between standard treatment versus add-on strength training (ST) for evaluation of efficacy of ST. |
Day 0, week 4, week 8, week 12 (for all) and week 24 (for active intervention group) |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Comparison of changes in electrophysiological biomarkers between standard treatment versus add-on strength training (ST) to understand the mechanism of strength training. |
Day 0, week 4, week 8, week 12 (for all) and week 24 (for active intervention group) |
| Comparison of reported adverse event frequency and other safety parameters between standard treatment versus add-on strength training (ST) for evaluation of safety of ST. |
Day 0, week 4, week 8, week 12 (for all) and week 24 (for active intervention group) |
| Comparison of changes in molecular biomarkers between standard treatment versus add-on strength training (ST) to understand the mechanism of strength training. |
Day 0, week 12 (for all) and week 24 (for active intervention group) |
|
|
Target Sample Size
|
Total Sample Size="122"
Sample Size from India="122"
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)
|
15/05/2025 |
| 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="3"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| 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
|
Rationale/ gaps in existing knowledge: Parkinson’s Disease (PD) currently affects around 1% of the population over sixty years of age, however, prevalence is expected to increase. In preliminary studies, lower limb strength training was effective at alleviating motor symptoms of PD, when used in conjunction with standard pharmacotherapy. The proposed study will provide definitive data on the efficacy and safety of strength training in PD patients, with particular relevance to India. Novelty: In addition to assessing efficacy and safety in the first ever randomized controlled trial (RCT) of strength training in India, the current study will throw light on novel mechanistic aspects, focussing on neural adaptations underpinning strength training. For the first time, we will explore the role of the Reticulospinal Tract (RST) in improving strength and motor symptoms in PD. Objectives: Assess the safety and efficacy of strength training as an add-on to standard pharmacotherapy for improvement of motor function, gait, selective non-motor functions in PD patients. Additionally, we will elucidate the mechanism of improvement through changes in molecular and electrophysiological biomarkers following strength training. Methods: A randomized controlled trial will be conducted on PD patients with gait impairment. The patients will be assigned to either strength training or no physical therapy groups in addition to stable dose of standard medications for 12 weeks. Clinical, electrophysiological outcomes and molecular biomarkers will be assessed at baseline and at 12 weeks. A post-treatment follow-up visit will be performed on active intervention group for similar assessments at week 24 to find out any carryover effect of strength training. |