| CTRI Number |
CTRI/2025/12/098375 [Registered on: 03/12/2025] Trial Registered Prospectively |
| Last Modified On: |
02/12/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Diagnostic
Screening
Physiotherapy (Not Including YOGA) |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Study on the Benefits of a Structured Exercise Program for Improving Heart Health, Blood Sugar, and Well-Being in Postmenopausal Women |
|
Scientific Title of Study
|
Impact of structured exercise program on dyslipidemia, blood pressure, C-reactive protein, quality of life and blood glucose in postmenopausal women: A 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 |
Sarika Bhati |
| Designation |
PG Student |
| Affiliation |
SGT University |
| Address |
Department of Physiotherapy, SGT University, Room No. 407, Division-B Block, Chandu-Budhera, Gurugram-Badli Road, Gurugram, Haryana 122505
Gurgaon
HARYANA
122505
India |
| Phone |
8851315723 |
| Fax |
|
| Email |
sarikabhati099@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Sarika Bhati |
| Designation |
PG Student |
| Affiliation |
SGT University |
| Address |
Department of Physiotherapy, SGT University, Room No. 407, Division-B Block, Chandu-Budhera, Gurugram-Badli Road, Gurugram, Haryana 122505
HARYANA
122505
India |
| Phone |
8851315723 |
| Fax |
|
| Email |
sarikabhati099@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Sarika Bhati |
| Designation |
PG Student |
| Affiliation |
SGT University |
| Address |
Department of Physiotherapy, SGT University, Room No. 407, Division-B Block, Chandu-Budhera, Gurugram-Badli Road, Gurugram, Haryana 122505
HARYANA
122505
India |
| Phone |
8851315723 |
| Fax |
|
| Email |
sarikabhati099@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Sarika Bhati |
| Address |
Department of Physiotherapy, SGT University, Room No. 407, Division-B Block, Chandu-Budhera, Gurugram-Badli Road, Gurugram, Haryana 122505 |
| Type of Sponsor |
Private 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 RENUKA JAKHAR |
SGT HOSPITAL |
Department of Physiotherapy, Room No. 407, Division-B Block, Chandu-Budhera, Gurugram-Badli Road, Gurugram, Haryana 122505
Gurgaon
HARYANA |
8851315723
Renuka_sphy@sgtuniversity.org |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICAL COMMITTEE FACULTY OF PHYSIOTHERAPY |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: I798||Other disorders of arteries, arterioles and capillaries in diseases classified elsewhere, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
CONVENTIONAL TT |
Participants in the control group will receive education about the condition, its consequences, the role of exercises, and general preventive measures. No structured exercise program will be provided. They will continue with their routine daily activities. |
| Intervention |
PHYSIOTHERAPY MANAGEMENT |
Breathing exercises (pursed lip breathing, deep breathing, diaphragmatic breathing):
Frequency: 3–5 days per week
Duration: 5 minutes
Dosage: 5–10 slow deep breaths per set
Aerobic exercises (brisk walking, jumping jacks, marching exercise):
Frequency: 3–5 days per week
Duration: 10 minutes
Dosage: 5–10 repetitions of jumping jacks and marching exercise
Resistance training with theraband (squats, calf raises, glute bridge):
Frequency: 3–5 days per week
Duration: 10 minutes
Dosage: 8–10 repetitions
Pelvic floor exercises (Kegels, bridge with pelvic squeeze):
Frequency: 3–5 days per week
Duration: 10 minutes
Dosage: 10 repetitions with 5–10 seconds hold
Cool down exercises (side flexion, calf stretch, hamstring stretch, biceps stretch):
Frequency: 3–5 days per week
Duration: 10 minutes
Dosage: Hold each stretch for 8–10 seconds with 5 repetitions |
|
|
Inclusion Criteria
|
| Age From |
50.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Female |
| Details |
Postmenopausal women aged 50 65 years with change in value of dyslipidemia any one value that is HDL, LDL, VLDL, Total cholesterol and Triglyceride, elevated blood pressure
Sedentary lifestyle or low physical activity less than 2 hours per week of structured exercise.
Did not have any chronic musculoskeletal disease.
No use of nutritional supplements which could affect the inflammatory markers.
|
|
| ExclusionCriteria |
| Details |
Women currently receiving hormone replacement therapy.
Severe comorbidities that make exercise training intolerant during treatment such as cancer, heart failure.
Women with psychiatric disorders.
Women with history of hyperlipidemia.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Change in lipid profile levels from baseline to 4 weeks. |
Baseline, 4 weeks. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| QUALITY OF LIFE |
Baseline, 4 weeks |
|
|
Target Sample Size
|
Total Sample Size="40"
Sample Size from India="40"
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 2 |
|
Date of First Enrollment (India)
|
15/12/2025 |
| 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="1"
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
|
Menopause is a natural stage in a woman’s life that often brings hormonal changes affecting heart health, metabolism, and overall well-being. Many women experience increased cholesterol, higher blood pressure, raised blood sugar, and inflammation during this phase, which can lower their quality of life. Regular exercise is known to improve these health issues, but there is still limited evidence on how a well-structured exercise program can affect all these factors together in postmenopausal women. This randomized controlled trial is designed to find out how a planned exercise routine can help improve lipid levels, blood pressure, C-reactive protein, blood glucose, and quality of life. Women taking part in the study will be randomly assigned to an exercise group or a control group. The exercise program will include supervised aerobic, strengthening, and pelvic floor exercises three times a week for four weeks. The results are expected to show how structured exercise can be a safe and effective way to enhance health and quality of life in postmenopausal women. |