Physical Activity and Quality of Life in Postmenopausal Women

NCT ID: NCT07074132

Last Updated: 2025-07-20

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 36 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-10-01
• Study Completion Date: 2025-05-31

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.

Conditions

Quality of Life; Fitness Testing

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: SINGLE

Study Groups

Training group

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.

Group Type: EXPERIMENTAL

Combined Aerobic and Muscle-Strengthening Training Program

Intervention Type: 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.

Control group

No training intervention was intended for the control group.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Combined Aerobic and Muscle-Strengthening Training Program

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.

Intervention Type: BEHAVIORAL

Eligibility Criteria

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.

• Minimum Eligible Age: 50 Years
• Maximum Eligible Age: 62 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Wissal Abassi

OTHER

Sponsor Role: lead

Responsible Party

Wissal Abassi

Principal Investigator

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Antonella MUSCELLA, Professor

Role: PRINCIPAL_INVESTIGATOR

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

Wissal Abassi, Dr

Role: PRINCIPAL_INVESTIGATOR

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

Locations

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

Lecce, LE (Lecce), Italy

Countries

Italy

Other Identifiers

PA-MenQL25

Identifier Type: -

Identifier Source: org_study_id