| CTRI Number |
CTRI/2025/08/093166 [Registered on: 18/08/2025] Trial Registered Prospectively |
| Last Modified On: |
15/08/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA) |
| Study Design |
Randomized, Parallel Group, Multiple Arm Trial |
|
Public Title of Study
|
"The Impact of Different Types of Exercise on Blood Pressure and Physical Well-Being in Post-Menopausal Women" |
|
Scientific Title of Study
|
Short- and Long-Term Effects of Aerobic, Resistance, and Combined Forms of
Exercise on Tissue Adaptability and Hypertension in Post-Menopausal 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 |
Aman Navneet Kaur |
| Designation |
Assistant Professor, Phd Scholar |
| Affiliation |
Department of Physiotherapy, Lovely Professional University |
| Address |
Lovely Professional University Jalandhar Delhi GT Road Phagwara Punjab India 144411
Jalandhar
PUNJAB
144411
India |
| Phone |
08054304902 |
| Fax |
|
| Email |
dr.amannavneet@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Zaki Anwer |
| Designation |
Professor |
| Affiliation |
Department of Physiotherapy, Lovely Professional University |
| Address |
Lovely Professional University Jalandhar Delhi GT Road Phagwara Punjab India 144411
Jalandhar
PUNJAB
144411
India |
| Phone |
9816285755 |
| Fax |
|
| Email |
zakian@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Zaki Anwer |
| Designation |
Professor |
| Affiliation |
Department of Physiotherapy, Lovely Professional University |
| Address |
Lovely Professional University Jalandhar Delhi GT Road Phagwara Punjab India 144411
Jalandhar
PUNJAB
144411
India |
| Phone |
9816285755 |
| Fax |
|
| Email |
zakian@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Aman Navneet Kaur |
| Address |
Lovely Professional University Jalandhar Delhi GT Road Phagwara Punjab India 144411 |
| Type of Sponsor |
Other [self] |
|
|
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 |
| Aman Navneet Kaur |
Lovely Professional University |
Room no 105 Block 3 OPD Department of Physiotherapy GT Road.
Jalandhar
PUNJAB |
08054304902
dr.amannavneet@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS COMMITTEE (IEC) |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: I10||Essential (primary) hypertension, (2) ICD-10 Condition: M368||Systemic disorders of connective tissue in other diseases classified elsewhere, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
group A : Aerobic Exercise
|
4-5 sessions per week
Moderate (40% - 59% VO2R or HRR; RPE 12-13) to Vigorous (60% - 80% VO2R or HRR; RPE 14-16)
50–60 minutes per day (including 5-10 min warm-up and cool-down)
Aerobic Exercises:
- Walking (treadmill or outdoors)
- Static cycling (stationary bike)
- Dynamic cycling (outdoor or stationary bike)
- Swimming
- Brisk walking on incline
|
| Comparator Agent |
group B: Resistance Exercise |
4-5 sessions per week
Moderate (60% - 70% 1-RM; progress to 80% 1-RM for advanced individuals; start with 40%-50% 1-RM for older adults)
60 minutes per session (2-4 sets of 8-12 repetitions for 8-10 major muscle group exercises, warm-up, and cool-down included)
Resistance Exercises:
- Chest press machine
- Leg press machine
- Seated row machine
- Leg curl machine
- Latissimus dorsi pull-down machine
- Leg extension machine
- Crunches (floor or machine)
- Back raises (machine or floor exercises)
|
| Comparator Agent |
group C: Combined Form (Aerobic and Resistance) |
4-5 sessions per week
Aerobic: Moderate (40% - 59% VO2R or HRR; RPE 12-13) to Vigorous (60% - 80% VO2R or HRR; RPE 14-16)
Resistance: Moderate (60% - 70% 1-RM; progress to 80% 1-RM for advanced individuals; start with 40%-50% 1-RM for older adults)
60 minutes per day (20-30 minutes aerobic, 20 minutes resistance, 5-10 minutes warm-up and cool-down)
Aerobic Exercises:
- Walking (treadmill or outdoors)
- Static cycling (stationary bike)
- Dynamic cycling (outdoor or stationary bike)
- Swimming
- Brisk walking on incline
Resistance Exercises:
- Chest press machine
- Leg press machine
- Seated row machine
- Leg curl machine
- Latissimus dorsi pull-down machine
- Leg extension machine
- Crunches (floor or machine)
- Back raises (machine or floor exercises)
|
|
|
Inclusion Criteria
|
| Age From |
50.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Female |
| Details |
Postmenopausal Status:
Natural Menopause: Absence of menstruation for 12 months or more (World Health Organization, 2022; North American Menopause Society, 2023).
Age Range:
Women aged between 50 and 65 years (World Health Organization, 2022; North American Menopause Society, 2023; American Heart Association, 2022)
Medication Use:
Participants may be on medication, but their condition must be stable with medical clearance from a healthcare provider.
Body Mass Index (BMI)
BMI between 18.5 and 29.9 kg/m² (Based on WHO classification).
Hypertension Status (Based on American Heart Association Guidelines)
Stage 1 Hypertension:
Systolic Blood Pressure: 130–139 mmHg
Diastolic Blood Pressure: 80–89 mmHg
New York Heart Association (NYHA) Classification for Heart Failure Risk:
Stage A: At risk for heart failure but with no symptoms or structural/functional heart disease.
Class I: No symptoms and no limitation in ordinary physical activity.
Prediabetes (Based on American Diabetes Association Criteria)
Participants must meet at least one of the following criteria for prediabetes:
A1C: 5.7%–6.4%
Fasting Blood Glucose (FBS): 100–125 mg/dL
Oral Glucose Tolerance Test (OGTT): 140–199 mg/dL
|
|
| ExclusionCriteria |
| Details |
Cardiorespiratory Disease
Includes any chronic heart disease such as heart failure inability of the heart to pump sufficient blood chronic obstructive pulmonary disease also called COPD coronary artery disease narrowing or blockage of coronary arteries or pulmonary hypertension increased blood pressure in the arteries of the lungs
Renal Pulmonary Skin and Gynecological Disorders
Renal Disorders Any chronic kidney disease or renal failure acute or chronic impacting kidney function
Pulmonary Disorders Conditions like asthma emphysema chronic bronchitis or any form of severe respiratory disease
Skin Disorders Severe dermatological conditions such as psoriasis eczema or chronic wounds or infections that could interfere with exercise or pose health risks
Gynecological Disorders Any condition affecting the female reproductive system including but not limited to endometriosis fibroids pelvic inflammatory disease or cervical cancer
Metabolic and Neuromuscular Disorders
Metabolic Disorders Conditions such as diabetes mellitus type one and type two hyperthyroidism hypothyroidism and metabolic syndrome a combination of hypertension high blood sugar excess body fat around the waist and abnormal cholesterol levels
Neuromuscular Disorders Conditions affecting the muscles and nervous system such as multiple sclerosis muscular dystrophy or amyotrophic lateral sclerosis also called ALS
Haematological and Neurological Disorders
Haematological Disorders Disorders like anemia low red blood cell count leukemia blood cancer or any condition affecting blood clotting such as hemophilia or thrombocytopenia
Neurological Disorders Conditions affecting the nervous system such as epilepsy stroke Parkinsons disease or dementia
Fractures in the Last Three Months
Any bone fractures such as fractures of the arms legs ribs or spine that occurred in the last three months due to the potential for further injury during physical activity
Ovarian and Breast Cancer
Ovarian Cancer or Breast Cancer either current or in remission especially if diagnosed within the past five years as these conditions require specific medical management and may be contraindicated for certain physical activities
Hormone Replacement Therapy Within the Past One to Two Years
Women who have undergone hormone replacement therapy HRT within the past one to two years for symptoms of menopause as HRT can alter the bodys hormonal balance and affect the response to exercise
Surgical Procedures Within the Past One to Two Years
Women who have undergone any major surgical procedures such as abdominal joint replacement or gynecological surgeries in the last one to two years which could interfere with their ability to engage in physical activity or pose health risks during exercise
Type One and Type Two Diabetes Mellitus
Women with type one diabetes insulin dependent or type two diabetes insulin resistance who have poorly controlled blood sugar levels as this condition requires careful management during physical activity and may increase the risk of complications like hypoglycemia or cardiovascular issues |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
1.Systolic and Diastolic Blood Pressure
2.Functional Status [Walking Distance (ms), Walking Time (s), Walking Speed (ms/s)]
3.Pulse Wave Velocity
|
Baseline
4 weeks
12 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| nil |
nil |
|
|
Target Sample Size
|
Total Sample Size="144"
Sample Size from India="144"
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)
|
15/09/2025 |
| 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="3"
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 - YES
- What data in particular will be shared?
Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).
- What additional supporting information will be shared?
Response - Study Protocol
Response - Statistical Analysis Plan
Response - Informed Consent Form
- Who will be able to view these files?
Response - Researchers who provide a methodologically sound proposal.
- For what types of analyses will this data be available?
Response - To achieve aims in the approved proposal.
- By what mechanism will data be made available?
Response - Proposals should be directed to [dr.amannavneet@gmail.com].
- For how long will this data be available start date provided 02-01-1970 and end date provided 02-01-1970?
Response - Beginning 3 months and ending 5 years following article publication.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - NIL
|
|
Brief Summary
|
This PhD thesis is a randomized comparative trial aimed at evaluating the short- and long-term effects of aerobic, resistance, and combined exercise training on cardiovascular health and functional capacity in postmenopausal women aged 50–65 with stage 1 hypertension and prediabetes. A total of 144 participants will be randomly assigned to one of the three exercise modalities, with interventions lasting 12 weeks and assessments conducted at baseline, 4 weeks, and 12 weeks. Outcomes will include blood pressure, arterial stiffness, and functional performance measures such as walking tests, flexibility, and balance. By directly comparing these exercise approaches, the research seeks to identify the most effective non-pharmacological strategy for mitigating cardiovascular risk factors and improving quality of life during the postmenopausal transition, addressing a significant gap in existing literature. |