Quality of LifeNCT07074132
Physical Activity and Quality of Life in Postmenopausal Women
A study testing Combined Aerobic and Muscle-Strengthening Training Program in people with Quality of Life and Fitness Testing, run by Wissal Abassi at 1 site in Italy.
Trial 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. Read more about this study
- Who is it for?
- Ages 50 to 62 years, women only
- Conditions the study is for
- Quality of Life, Fitness Testing
- What is being tested?
- Combined Aerobic and Muscle-Strengthening Training Program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 siteItaly
- Study dates
- 1 Oct 2024to 31 May 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 to 62 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- 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).
Who cannot join
- Medical contraindications to physical activity.
- Metabolic, hormonal, orthopedic, or cardiovascular diseases.
- Current use of hormone replacement therapy or any prescribed medication.
Trial locations and contacts
1 site in 1 country.
Italy1 site
Department of Biological and Environmental Sciences and Technologies (DiSTeBA), University of Salento, Centro Ecotekne, Pal. B S.P. 6
Lecce, LE (Lecce), 73100
About this study
Official title: Impact of a Physical Activity Program on Body Composition, Strength, 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.
Read the 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
- Being tested
- Combined Aerobic and Muscle-Strengthening Training Program
- Keywords
- Obesity, Physical fitness, Long-term intervention, Combined exercise, Quality of life, Postmenopausal women
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Combined Aerobic and Muscle-Strengthening Training ProgramBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Combined Aerobic and Muscle-Strengthening Training Program |
| Control group | No intervention | No training intervention was intended for the control group. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Baseline (Day 0) and after 8 months of intervention.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jul 2025
- Study start1 Oct 2024
- Primary completion31 May 2025
- Study completion31 May 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Quality of LifeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- Wissal Abassi
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Wissal Abassi, High Institute of Sports and Physical Education of Kef
- Investigators
- Antonella MUSCELLA, Professor, Principal investigator, Department of Biological and Environmental Science and Technologies (DiSTeBA), University of Salento, 73100 Lecce, Italy.Wissal Abassi, Dr, 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.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07074132
- Sponsor's protocol ID
- PA-MenQL25
- Status last verified
- May 2025
- First submitted
- 9 Jul 2025
- Last updated
- 20 Jul 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: For confidentiality reasons, all data from this study are available upon request.
Study at a glance
From the registry record, last updated by the sponsor on 20 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of a Physical Activity Program on Body Composition, Strength, and Quality of Life in Postmenopausal Women
- ClinicalTrials.gov ID
- NCT07074132
- Acronym / sponsor ID
- PA-MenQL25
- Conditions
- Quality of Life, Fitness Testing
- Keywords
- Obesity, Physical fitness, Long-term intervention, Combined exercise, Quality of life, Postmenopausal women
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- Wissal AbassiUniversity, hospital or other
- Study start
- 1 Oct 2024 (actual)
- Primary completion
- 31 May 2025 (actual)
- Study completion
- 31 May 2025 (actual)
- First posted
- 20 Jul 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Training group | Experimental | Behavioral: Combined Aerobic and Muscle-Strengthening Training ProgramThe 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. |
| Control group | No intervention | –No training intervention was intended for the control group. |
Who may qualify
- Ages
- 50 to 62 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (3 listed)
- Medical contraindications to physical activity.
- Metabolic, hormonal, orthopedic, or cardiovascular diseases.
- Current use of hormone replacement therapy or any prescribed medication.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Combined Aerobic and Muscle-Strengthening Training ProgramA 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. | Behavioural | Training group |
Primary outcome
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).
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).
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).
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).
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).
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.
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.
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.
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jul 2025.
- Individual participant dataSharing planned: No. For confidentiality reasons, all data from this study are available upon request.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Antonella MUSCELLA, Professor principal investigator
Department of Biological and Environmental Science and Technologies (DiSTeBA), University of Salento, 73100 Lecce, Italy.
Wissal Abassi, Dr 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Combined Aerobic and Muscle-Strengthening Training Program in people with Quality of Life and Fitness Testing, run by Wissal Abassi at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Body weight (time frame: Baseline (Day 0) and after 8 months of intervention.). The study lists 9 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Jul 2025.