Exercise vs Relaxation for Heart Function and Quality of Life in Obesity

Comparison of the effect of a Structured exercise program and Relaxation Therapy on Heart Rate Variability and Quality of Life in Obese Adults A Randomized Clinical Trial - NIL

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2026/06/112224

Enrollment

159

Registered

2026-06-08

Start date

Unknown

Completion date

Unknown

Last updated

2026-06-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: E65-E68- Overweight, obesity and other hyperalimentation

Interventions

Intervention1: Structured Exercise Program: Exercise program for 30 minutes, 5 days a week for 12 weeks which includes Aerobic exercises at moderate intensity involving large muscle groups for 20 minu

Eligibility

Inclusion criteria

Inclusion criteria: BMI Between 25kg/m2 to 34.9 kg/m2 waist circumference greater than 90 cm in males and greater than 80 cm in females Subjects not undergoing any structured exercise program in the past six months Those who fulfil PAR Q Plus Criteria

Exclusion criteria

Exclusion criteria: Patients with Severe Obesity (greater than 35 kg/m2) and Morbidly Obese individuals (greater than 40kg/m2) Patients with Arrythmias, diagnosed cases of chronic heart failure or those with Overt cardiovascular disease. Patients with severe DM requiring Insulin or those with Grade III Hypertension Presence of symptoms suggestive of peripheral or autonomic neuropathy, such as giddiness on standing, urinary urgency, tingling sensation of limbs, or limb weakness Other previously known chronic conditions such as cancer, immunodeficiency, autoimmune diseases Any other medical condition or disability restricting patient participation.

Design outcomes

Primary

Measure	Time frame
Heart Rate Variability using a software to calculate and compute RR intervals in a 12 lead ECG in supine for 30 minutesTimepoint: at the time of registration into the trial at the end of 6 weeks at the end of 12 weeks	—

Secondary

Measure	Time frame
The Medical Outcomes Study Short Form 36 (SF-36 v2) Health related QOL QuestionnaireTimepoint: at the time of registration into the trial at the end of 6 weeks at the end of 12 weeks;Body Mass will be measured to the closest 0.1 kg using a standard weighing scale without shoes. Height will be measured to the closest 0.1 cm without shoes using a standard stadiometer. The BMI will be calculated as body mass divided by height squared (kg/m2). Waist circumferenceTimepoint: at the time of registration into the trial at the end of 6 weeks	—

Measure

Time frame

The Medical Outcomes Study Short Form 36 (SF-36 v2) Health related QOL QuestionnaireTimepoint: at the time of registration into the trial at the end of 6 weeks at the end of 12 weeks;Body Mass will be measured to the closest 0.1 kg using a standard weighing scale without shoes. Height will be measured to the closest 0.1 cm without shoes using a standard stadiometer. The BMI will be calculated as body mass divided by height squared (kg/m2). Waist circumferenceTimepoint: at the time of registration into the trial at the end of 6 weeks

—

Countries

India

Contacts

Public ContactZahara Polen

Smt. Kashibai Navale College of Physiotherapy, Pune.

zaharapolen.skncopt@sinhgad.edu918237767363

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Jun 29, 2026