Physical Activity and Quality of Life in Postmenopausal Women

NCT07074132 | Completed DMC

• 1 other identifier: PA-MenQL25
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this clinical trial is to investigate the effects of a combined aerobic and muscle-strengthening training program on body composition, physical fitness, and quality of life in overweight or obese postmenopausal women. The main question it aims to answer is: Does this training modality improve body composition, enhance physical fitness, and increase quality of life in this population ? Researchers will compare outcomes between an experimental group following the training protocol and a control group with no training intervention, in order to determine whether the program leads to measurable improvements in these parameters. Participants in the training group will engage in aerobic exercise at 50-70% of heart rate reserve (HRR) and strength training at 60-70% of one-repetition maximum (1-RM), three times per week for 8 months. Participants in the control group will not engage in any structured physical training and will be asked to maintain their usual daily routines.

Conditions

Quality of Life; Fitness Testing

Keywords

Obesity; Physical fitness; Long-term intervention; Combined exercise; Quality of life; Postmenopausal women

Outcome Measures

Primary Outcomes (9)

• Body weight

  Body weight (kg) was recorded with participants barefoot and wearing light clothing, using the InBody 270 bioelectrical impedance device (InBody, Cerritos, CA, USA).

  Baseline (Day 0) and after 8 months of intervention.

• Body fat

  Body fat (%) was recorded using the InBody 270 bioelectrical impedance device (InBody, Cerritos, CA, USA).

  Baseline (Day 0) and after 8 months of intervention.

• Body mass index

  Body mass index (kg/m²) was calculated as weight (kg) divided by height squared (m²).

  Baseline (Day 0) and after 8 months of intervention.

• Lean mass

  Lean mass (%) was recorded with participants barefoot and wearing light clothing, using the InBody 270 bioelectrical impedance device (InBody, Cerritos, CA, USA).

  Baseline (Day 0) and after 8 months of intervention.

• Basal metabolic rate

  Basal metabolic rate (kcal/day) was assessed using the InBody 270 bioelectrical impedance device (InBody, Cerritos, CA, USA).

  Baseline (Day 0) and after 8 months of intervention.

• Aerobic Capacity

  Aerobic capacity was assessed using the 6-minute walk test (6MWT), administered according to standardized procedures, with participants walking on a flat, straight course for six minutes.

  Baseline (Day 0) and after 8 months of intervention.

• Lower limb functional strength.

  Lower limb functional strength was assessed using the 30-Second Chair Stand Test.

  Baseline (Day 0) and after 8 months of intervention.

• Agility and dynamic balance

  Agility and dynamic balance were assessed using the 8-Foot Up and Go (8UG) test.

  Baseline (Day 0) and after 8 months of intervention.

• Quality of life (SF-36 Questionnaire)

  Quality of life was assessed using the Short Form Health Survey 36 (SF-36), a validated 36-item questionnaire measuring physical and mental health domains.

  Baseline (Day 0) and after 8 months of intervention.

Study Arms (2)

Training group

EXPERIMENTAL

The experimental group performed a combined training program consisting of aerobic training at 50-70% of heart rate reserve (HRR) and muscle-strengthening training at 60-70% of one-repetition maximum (1-RM), three times per week for eight months.

Behavioral: Combined Aerobic and Muscle-Strengthening Training Program

Control group

NO INTERVENTION

No training intervention was intended for the control group.

Interventions

Combined Aerobic and Muscle-Strengthening Training Program BEHAVIORAL

A combined training program including both aerobic and muscle-strengthening physical activities within the same session, conducted over a period of 8 months. Aerobic training is performed at an intensity of 50-70% of heart rate reserve (HRR), and strength training at 60-70% of one-repetition maximum (1-RM). The training is conducted three times per week.

Training group

Eligibility Criteria

• Age: 50 Years - 62 Years
• Gender Eligibility Details: Female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Age range (50-62 years).
• Postmenopausal women (absence of menstruation \> 12 months).
• Body mass index (BMI) ≥ 25 kg/m².
• Body weight remained constant (±2 kg) for the past 3 months.
• Stable dietary habits and physical activity for at least 3 months.
• Sedentary lifestyle (physical activity less than 1 hour per week).

You may not qualify if:

• Medical contraindications to physical activity.
• Metabolic, hormonal, orthopedic, or cardiovascular diseases.
• Current use of hormone replacement therapy or any prescribed medication.

Sponsors & Collaborators

• Wissal Abassi: lead

Study Sites (1)

Department of Biological and Environmental Sciences and Technologies (DiSTeBA), University of Salento, Centro Ecotekne, Pal. B S.P. 6

Lecce, LE (Lecce), 73100, Italy

Location

MeSH Terms

Conditions

Obesity

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Antonella MUSCELLA, Professor

  Department of Biological and Environmental Science and Technologies (DiSTeBA), University of Salento, 73100 Lecce, Italy.

  PRINCIPAL INVESTIGATOR

• Wissal Abassi, Dr

  Research Unit "Sport Sciences, Health and Movement"(UR22JS01) High Institute of Sport and Physical Education of Kef, University of Jendouba, 7100 Kef, Tunisia.

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: July 9, 2025
• First Posted: July 20, 2025
• Study Start: October 1, 2024
• Primary Completion: May 31, 2025
• Study Completion: May 31, 2025
• Last Updated: July 20, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)