| CTRI Number |
CTRI/2026/02/103532 [Registered on: 10/02/2026] Trial Registered Prospectively |
| Last Modified On: |
10/02/2026 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Yoga & Naturopathy Other (Specify) [Meditation] |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Effects of yoga and meditation on ability to move and sleep in Parkinsons disease |
|
Scientific Title of Study
|
Effects of yoga and meditation on motor function, objective and subjective sleep in Parkinsons disease: a pilot randomized controlled trial |
| 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 MEENA MIRDHA |
| Designation |
ASSOCIATE PROFESSOR |
| Affiliation |
AIIMS Bathinda |
| Address |
Department of Physiology
Room no A311
2nd floor A block
Medical college building
AIIMS Bathinda
Bathinda PUNJAB 151001 India |
| Phone |
8506912395 |
| Fax |
|
| Email |
dr.meenamirdha@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr MEENA MIRDHA |
| Designation |
ASSOCIATE PROFESSOR |
| Affiliation |
AIIMS Bathinda |
| Address |
Department of Physiology
Room no A311
2nd floor A block
Medical college building
AIIMS Bathinda
Bathinda PUNJAB 151001 India |
| Phone |
8506912395 |
| Fax |
|
| Email |
dr.meenamirdha@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Dr MEENA MIRDHA |
| Designation |
ASSOCIATE PROFESSOR |
| Affiliation |
AIIMS Bathinda |
| Address |
Department of Physiology
Room no A311
2nd floor A block
Medical college building
AIIMS Bathinda
Bathinda PUNJAB 151001 India |
| Phone |
8506912395 |
| Fax |
|
| Email |
dr.meenamirdha@gmail.com |
|
|
Source of Monetary or Material Support
|
| AIIMS Bathinda intramural grant aided project
AIIMS Bathinda Punjab
India
Pin 151001 |
|
|
Primary Sponsor
|
| Name |
AIIMS Bathinda |
| Address |
AIIMS Bathinda
Punjab
151001 |
| Type of Sponsor |
Government medical college |
|
|
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 MEENA MIRDHA |
AIIMS BATHINDA |
Department of Physiology
Room no A311
2nd floor A block
Medical college building
151001 Bathinda PUNJAB |
8506912395
dr.meenamirdha@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, AIIMS, Bathinda |
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 |
Meditation |
Meditation guided by a trained yoga instructor, such as mindful breathing. Changing the meditation sequence or chanting a simple mantra with participants will be done.12 weeks meditation program will be held twice weekly for 50 minutes along with routine care as advised for treatment |
| Intervention |
Meditation |
Meditation guided by a trained yoga instructor, such as mindful breathing. Changing the meditation sequence or chanting a simple mantra with participants will be done.12 weeks meditation program will be held twice weekly for 50 minutes along with routine care as advised for treatment |
| Intervention |
Yoga |
Weekly two sessions of the yoga program included the following five poses:
mountain pose, raised arm pose, revolved abdomen pose, warrior pose, cobra pose. 12 weeks yoga program in which yoga sessions will be held twice weekly for 50 minutes, along with routine care as advised for treatment. |
| Comparator Agent |
Yoga |
Weekly two sessions of the yoga program included the following five poses: mountain pose, raised arm pose, revolved abdomen pose, warrior pose, cobra pose.12 weeks yoga program in which yoga sessions will be held twice weekly for 50 minutes, along with routine care as advised for treatment. |
|
|
Inclusion Criteria
|
| Age From |
45.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
Idiopathic PD
Hoehn and Yahr stage 1-3
stable medication regimen for at least four weeks prior to study entry |
|
| ExclusionCriteria |
| Details |
atypical or secondary Parkinsonism
multiple strokes
inability to walk without a walker
Montreal Cognitive Assessment (MoCA) score less than or equal to 26
deep brain stimulation
untreated sleep apnea, coronary artery disease, Diabetes mellitus, chronic obstructive pulmonary disease, chronic kidney disease, had a decline in immune function such as pneumonia or systemic infection
patients who were already practicing yoga and meditation regularly. |
|
|
Method of Generating Random Sequence
|
Adaptive randomization, such as minimization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
Primary objective: To compare motor function and sleep outcomes in meditation, yoga, and control groups after intervention.
|
12 weeks
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To assess meditation and yoga’s feasibility, acceptability, and preliminary effects on motor function and sleep outcomes in Parkinson’s disease.
|
12 weeks |
|
|
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)
|
27/02/2026 |
| 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
|
This pilot randomized controlled trial investigates the feasibility, acceptability, and preliminary effects of yoga and meditation on motor function and sleep outcomes in Parkinson disease patients. Parkinson disease a progressive neurodegenerative disorder often leads to sleep dysfunction with reduced efficiency while pharmacologic treatments cause side effects and limited non-pharmacologic options exist. This study addresses this gap by randomly allocating 30 patients (10 per group: yoga, meditation, control) with idiopathic PD (Hoehn-Yahr stage 1-3, age greater than equal to 45, stable medications) excluding comorbidities or prior yoga meditation practitioners. Over 12 weeks, yoga and meditation groups receive twice-weekly 50-minute supervised sessions alongside routine care; yoga includes poses like mountain, warrior, and cobra; meditation features mindful breathing and mantras. The control group undergoes standard rehabilitation program. Outcomes are assessed at baseline and post-intervention: primary measures include motor function via Unified PD Rating Scale (UPDRS) motor score, objective sleep (actigraphy efficiency, total sleep time, latency, wake after sleep onset), and subjective sleep (PDSS). Secondary objectives evaluate feasibility and group comparisons. Analysis uses paired t tests for within group changes, linear regression for between-group effects (controlling confounders like gender BMI, modifier medication), and descriptive statistics in SPSS. With a convenience sample of 30, this pilot draws from similar studies, prioritizing ethical consent and bias mitigation via validated tools. Expected outcomes include improved sleep motor function, informing targeted interventions with minimal risks (mild yoga discomfort) and societal benefits for elderly PD management. |