CTRI/2025/08/093166Not yet recruitingNot Applicable
Short- and Long-Term Effects of Aerobic, Resistance, and Combined Forms of Exercise on Tissue Adaptability and Hypertension in Post-Menopausal Women
Aman Navneet Kaur1 site in 1 country144 target enrollmentStarted: September 15, 2025Last updated:
Trial Snapshot
- Phase
- Not Applicable
- Status
- Not yet recruiting
- Sponsor
- Enrollment
- 144
- Locations
- 1
- Primary Endpoint
- 1.Systolic and Diastolic Blood Pressure
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Coin toss, Lottery, toss of dice, shuffling cards etc
- Masking
- None
Eligibility Criteria
- Ages
- 50.00 Year(s) to 65.00 Year(s) (—)
- Sex
- Female
Inclusion Criteria
- •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.
Exclusion Criteria
- •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.
Outcomes
Primary Outcomes
1.Systolic and Diastolic Blood Pressure
Time Frame: Baseline | 4 weeks | 12 weeks
2.Functional Status [Walking Distance (ms), Walking Time (s), Walking Speed (ms/s)]
Time Frame: Baseline | 4 weeks | 12 weeks
3.Pulse Wave Velocity
Time Frame: Baseline | 4 weeks | 12 weeks
Secondary Outcomes
No secondary outcomes reported
Investigators
Aman Navneet Kaur
Department of Physiotherapy, Lovely Professional University
Study Sites (1)
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