| CTRI Number |
CTRI/2025/09/095144 [Registered on: 19/09/2025] Trial Registered Prospectively |
| Last Modified On: |
22/09/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA) |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
How Qigong Exercise Affects Strength Tiredness and Sleep in Menopausal Women |
|
Scientific Title of Study
|
Effect of Qigong exercise on Muscle Strength Fatigue level and Sleep Quality in Menopausal Women A Randomized Control Trail |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Vishva Khakhkhar Ajay |
| Designation |
MPT student |
| Affiliation |
Parul university |
| Address |
Parul Sevashram Hospital physiotherapy department
room no 10
taluka waghodia
Vadodara Gujarat
Parul Sevashram Hospital physiotherapy department
room no 10
taluka waghodia
Vadodara Gujarat
Vadodara
GUJARAT
391760
India |
| Phone |
9824477750 |
| Fax |
|
| Email |
khakhkharvishva30@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Jahanvi Dave |
| Designation |
Assistant professor |
| Affiliation |
Parul university |
| Address |
Parul Sevashram Hospital physiotherapy department
room no 10
taluka waghodia
Vadodara Gujarat
Vadodara
GUJARAT
391760
India |
| Phone |
9998028702 |
| Fax |
|
| Email |
jahanvi.dave41102@paruluniversity.ac.in |
|
Details of Contact Person
Public Query
|
| Name |
Vishva Khakhkhar Ajay |
| Designation |
MPT student |
| Affiliation |
Parul university |
| Address |
Parul Sevashram Hospital physiotherapy department
room no 10
taluka waghodia
Vadodara Gujarat
Parul Sevashram Hospital physiotherapy department room no 10 taluka waghodia
Vadodara Gujarat
Vadodara
GUJARAT
391760
India |
| Phone |
9824477750 |
| Fax |
|
| Email |
khakhkharvishva30@gmail.com |
|
|
Source of Monetary or Material Support
|
| parul sevashram hospital
physiotherapy department
room no 10
taluka Waghodia
Gujarat Vadodara 391760 |
|
|
Primary Sponsor
|
| Name |
NIL |
| Address |
NIL |
| Type of Sponsor |
Other [NIL] |
|
|
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 |
| Vishva Khakhkhar |
Parul Sevashram Hospital |
1st floor physiotherapy department room no 10 post office limda taluka Waghodia
Vadodara Gujarat 391760
Vadodara
GUJARAT |
9824477750
khakhkharvishva30@gmail.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| parul University Institutional Ethics Committee For Human Research |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Menopausal women |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Qigong exercise |
8 brocades of exercise for beginners
1 Two hands hold up the heavens 10 repetition 10 seconds hold
2 Drawing the bow 10 repetition 10 seconds hold
3 Separating heaven and earth 10 repetition 10 seconds hold
4 Wise owl gazes backwards 10 repetition 10 seconds hold
5 Shake the head and swing tail 10 repetition 10 seconds hold
6 Reaching the feet 10 repetition 10 seconds hold
7 Clench the feet and gaze fiercely 10 repetition 10 seconds hold
8 Bouncing on the toes 10 repetition 10 seconds hold
8 reps in 2 sets
30 mins total duration
|
| Comparator Agent |
Traditional physiotherapy exercises |
squats 10 reps
leg press 10 reps
bridging 10 reps
pelvic tilts 10 reps
hip adductor stretch for 15 sec into 3 reps
hip flexor 15 sec hold into 3 reps
pursed lip breathing 5 times
diaphragmatic breathing 5 times 30 minute total duration
|
|
|
Inclusion Criteria
|
| Age From |
40.00 Year(s) |
| Age To |
55.00 Year(s) |
| Gender |
Female |
| Details |
Women having Amenorrhea for 1 or more than one year
Women in natural or surgical menopause
Reporting moderate to severe sleep disturbances Pittsburgh Sleep Quality Index more than 5 score
Willingness to participate in Qigong sessions for 8 weeks |
|
| ExclusionCriteria |
| Details |
Women having menopause less than 1 year were excluded.
Presence of any severe musculoskeletal or neurological disorders
Current participation in other structured exercise programs
Use of medications or therapies affecting muscle strength fatigue or sleep quality |
|
|
Method of Generating Random Sequence
|
|
|
Method of Concealment
|
|
|
Blinding/Masking
|
|
|
Primary Outcome
|
| Outcome |
TimePoints |
| Muscle strength Lumbar pressure biofeedback |
8 Weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Pittsburgh sleep quality index
Fatigue rating scale |
8 week |
|
|
Target Sample Size
|
Total Sample Size="90"
Sample Size from India="90"
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)
|
30/09/2025 |
| 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="6"
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
|
Menopause often leads to reduced muscle strength, increased fatigue, and poor sleep, affecting women’s daily life and well-being. Qigong, a gentle mind-body exercise, may help improve these issues, but there is limited research specifically on menopausal women. This study is needed to provide evidence on whether Qigong or Traditional physiotherapy exercises work better to enhance strength reduce fatigue and improve sleep in this population. Procedure 1 Screening of Participants Participants will be screened based on predefined inclusion and exclusion criteria 2 Selection of Participants Eligible individuals will be recruited and the total number of participants will be finalized 3 Informed Consent Written informed consent will be obtained from all participants prior to participation 4 Randomization and Pre Assessment Participants will be randomly allocated into two groups Group A Qigong Exercise Group B Conventional Treatment Baseline pre-assessment of outcome measures will be conducted. 5. Intervention Phase Group A Will undergo Qigong exercise sessions. Group B Will receive normal Physiotherapy exercises sessions. The intervention will continue for 8 weeks 6 Post Assessment After the intervention period outcome measures will be reassessed in both groups 7 Data Analysis The collected data will be subjected to statistical analysis to determine the effectiveness of the intervention 8 Result Findings will be presented and interpreted based on statistical outcomes |