| CTRI Number |
CTRI/2024/07/070474 [Registered on: 11/07/2024] Trial Registered Prospectively |
| Last Modified On: |
10/07/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA) |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Benefits of Aerobic Exercise for Women After Menopause: Fitness, Balance, Energy, and Quality of Life" |
|
Scientific Title of Study
|
Effect of aerobic exercises on fitness balance fatigue and quality of life in postmenopausal women |
| 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 Nikita |
| Designation |
Post graduate Masters of Physiotherapy |
| Affiliation |
Pandit B.D. Sharma PGIMS, Rohtak |
| Address |
Physiotherapy de[patment , E-Block, College of Physiotherapy, Pandit B.D. Sharma, PGIMS, Rohtak
Rohtak
HARYANA
124001
India |
| Phone |
8307699682 |
| Fax |
|
| Email |
nikita24899@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DrDimple Choudhry |
| Designation |
Assistant Professor |
| Affiliation |
Pandit B.D. Sharma PGIMS, Rohtak |
| Address |
College of Physiotherapy, Pandit B.D. Sharma, PGIMS, Rohtak
Rohtak
HARYANA
124001
India |
| Phone |
8307699682 |
| Fax |
|
| Email |
dimplephysio80@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
DrNikita |
| Designation |
Post graduate student |
| Affiliation |
Pandit B.D. Sharma PGIMS, Rohtak |
| Address |
Physiotherapy Department, E BLOCK, College of Physiotherapy, Pandit B.D. Sharma, PGIMS, Rohtak
Rohtak
HARYANA
124001
India |
| Phone |
8307699682 |
| Fax |
|
| Email |
nikita24899@gmail.com |
|
|
Source of Monetary or Material Support
|
| College of Physiotherapy,
Pandit B.D. Sharma, PGIMS, Rohtak 124001,Haryana, India |
|
|
Primary Sponsor
|
| Name |
Dr Nikita |
| Address |
College of Physiotherapy, Pandit B.D. SHARMA, PGIMS, ROHTAK 124001,Haryana, Rohtak |
| Type of Sponsor |
Other [Self] |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Dr Dimple Choudhry |
College of Physiotherapy Pandit B.D. SHARMA, PGIMS, ROHTAK 124001,Haryana, India |
| Dr Meenakshi B Chauhan |
Pandit B.D. SHARMA, PGIMS, ROHTAK- 124001,Haryana, India |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Nikita |
Pandit B.D. Sharma, PGIMS, Rohtak |
Physiotherapy Department
Rohtak
HARYANA |
8307699682
nikita24899@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Biomedical Research Ethics Committe Pandit B.D.Sharma, PGIMS, Rohtak |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: N951||Menopausal and female climactericstates, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
aerobic exercise |
aerobic exercise on fitness for 6 weeks
|
| Intervention |
aerobic exercises |
aerobic exercises on balance for 6 weeks |
| Intervention |
aerobic exercises |
aerobic exercises on fatigue for 6 weeks |
| Intervention |
aerobic exercises |
aerobic exercises on quality of life for 6 weeks |
| Comparator Agent |
Not Applicable |
Not Applicable |
|
|
Inclusion Criteria
|
| Age From |
45.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Female |
| Details |
1. Postmenopausal women (no menstruation for more than12 months before study).
2.Total hysterectomy with bilateral salpingo-oophorectomy or bilateral
oophorectomy ( more than 12 months before study |
|
| ExclusionCriteria |
| Details |
1. Using Hormonal replacement therapy.
2.Cardiovascular, Respiratory, or neurological disorders, any clinically
diagnosed psychiatric problem.
3.Any musculoskeletal injuries involving upper and lower extremities.
4.History of any surgery in the past one year other than Total hysterectomy with
bilateral salpingo-oophorectomy or bilateral oophorectomy.
5.Using any kind of walking aids |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Strength and endurance- 30s Chair stand
test
Power- Seated medicine ball throw
Flexibility- Sit and reach test
Balance Berg Balance Scale
Fatigue Severity Scale |
Baseline, third week and sixth week |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Menopause specific quality of life scale |
Pre test (zero week)
Post test 1 (3rd week)
Post test 2 ( 6th week) |
|
|
Target Sample Size
|
Total Sample Size="100"
Sample Size from India="100"
Final Enrollment numbers achieved (Total)= "100"
Final Enrollment numbers achieved (India)="100" |
|
Phase of Trial
|
Phase 2/ Phase 3 |
|
Date of First Enrollment (India)
|
28/07/2024 |
| Date of Study Completion (India) |
31/08/2025 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Completed |
| Recruitment Status of Trial (India) |
Completed |
|
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
|
In my study , I will investigate the effects of 6 week aerobic exercise program, conducted three times per week, on fitness, balance, fatigue levels and quality of life in postmenopausal women. Measurements will be taken at baseline, the 3rd week, and the 6th week to assess changes over time. |