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NCT Number: NCT07074132

Physical Activity and Quality of Life in Postmenopausal Women

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.

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Key information

Conditions

Quality of Life Body Weight Fitness Testing Nutrition Disorders Nutritional and Metabolic Diseases Obesity Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

50 year–62 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

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

Lecce, LE (Lecce), 73100, Italy

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Primary outcomes

  1. Body weight

    Time frame: 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).

  2. Body fat

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

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

  3. Body mass index

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

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

  4. Lean mass

    Time frame: 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).

  5. Basal metabolic rate

    Time frame: 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).

  6. Aerobic Capacity

    Time frame: 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.

  7. Lower limb functional strength.

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

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

  8. Agility and dynamic balance

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

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

  9. Quality of life (SF-36 Questionnaire)

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Wissal Abassi

Other

Registry information

Official study title

Impact of a Physical Activity Program on Body Composition, Strength, and Quality of Life in Postmenopausal Women

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Jul 20, 2025
Registry last updated
Jul 20, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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