Physical Activity and Quality of Life in Postmenopausal Women

Not Applicable

Completed

• Conditions: Quality of Life; Fitness Testing

• Registration Number: NCT07074132
• Lead Sponsor: Wissal Abassi

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.

Detailed Description

Overweight and obesity in postmenopausal women are associated with adverse changes in body composition, decreased physical fitness, and a decline in overall quality of life. The postmenopausal period is marked by hormonal changes that contribute to increased fat accumulation, loss of muscle mass, and heightened vulnerability to metabolic and cardiovascular diseases. These changes often lead to reduced functional capacity and well-being. Although exercise has been widely recognized as an effective strategy for improving health outcomes, there is a lack of long-term intervention studies combining aerobic and strength training in this specific population. The purpose of this clinical trial is to investigate the effects of a combined aerobic and muscle-strengthening training program for 8 months on body composition, physical fitness, and quality of life in overweight or obese postmenopausal women.

Thirty-six overweight/obese postmenopausal women were randomly assigned to either a training (n = 18), or a control group (n = 18). The training group will engage in aerobic exercise at 50-70% HRR and strength training at 60-70% 1-RM, three times per week for eight months. The control group will not participate in any structured physical training and will be instructed to maintain their usual lifestyle habits. Assessments of body composition, physical fitness, and quality of life were assessed before and after the intervention.

Study Timeline

• Study Start: 2024-10-01
• Status Verified: 2025-05
• Primary Completion: 2025-05-31
• Study Completion: 2025-05-31
• Study First Submitted: 2025-07-09
• Study First Submitted QC: 2025-07-17
• Last Update Submitted: 2025-07-17
• Study First Posted: 2025-07-20
• Last Update Posted: 2025-07-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 36

Inclusion Criteria

• 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).

Exclusion Criteria

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Body weight	Baseline (Day 0) and after 8 months of intervention.	Body weight (kg) was recorded with participants barefoot and wearing light clothing, using the InBody 270 bioelectrical impedance device (InBody, Cerritos, CA, USA).
Body fat	Baseline (Day 0) and after 8 months of intervention.	Body fat (%) was recorded using the InBody 270 bioelectrical impedance device (InBody, Cerritos, CA, USA).
Lean mass	Baseline (Day 0) and after 8 months of intervention.	Lean mass (%) was recorded with participants barefoot and wearing light clothing, using the InBody 270 bioelectrical impedance device (InBody, Cerritos, CA, USA).
Body mass index	Baseline (Day 0) and after 8 months of intervention.	Body mass index (kg/m²) was calculated as weight (kg) divided by height squared (m²).
Basal metabolic rate	Baseline (Day 0) and after 8 months of intervention.	Basal metabolic rate (kcal/day) was assessed using the InBody 270 bioelectrical impedance device (InBody, Cerritos, CA, USA).
Aerobic Capacity	Baseline (Day 0) and after 8 months of intervention.	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.
Lower limb functional strength.	Baseline (Day 0) and after 8 months of intervention.	Lower limb functional strength was assessed using the 30-Second Chair Stand Test.
Agility and dynamic balance	Baseline (Day 0) and after 8 months of intervention.	Agility and dynamic balance were assessed using the 8-Foot Up and Go (8UG) test.
Quality of life (SF-36 Questionnaire)	Baseline (Day 0) and after 8 months of intervention.	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.

Trial Locations

Locations (1)

Department of Biological and Environmental Sciences and Technologies (DiSTeBA), University of Salento, Centro Ecotekne, Pal. B S.P. 6; 🇮🇹 Lecce, LE (Lecce), Italy