Healthy AgingMD-EX WomenNCT07311265
Multi-Domain Exercise Program In Older Women
A study testing Supervised Multidomain Exercise Program in people with Healthy Aging and Overweight and Obesity, run by Universidade do Oeste de Santa Catarina at 1 site in Brazil.
Trial summary
The goal of this clinical trial is to learn whether a long-term exercise program can improve physical health and well-being in older women aged 60 years and older who live in the community. Read more about this study
- Who is it for?
- Ages 60 to 100 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy Aging, Overweight and Obesity, Physical Fitness
- What is being tested?
- Supervised Multidomain Exercise Program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 108 participants
- Where
- 1 siteBrazil
- Study dates
- 10 Mar 2023to 10 Dec 2024
- 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 60 to 100 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Women aged 60 years or older.
- Living independently in the community.
- Ability to walk independently, with or without assistive devices.
- Medical clearance to participate in physical exercise.
- Willingness to participate in the exercise program for 12 months.
- Signed informed consent form.
Who cannot join
- Presence of severe cardiovascular, respiratory, neurological, or musculoskeletal diseases that contraindicate physical exercise.
- Cognitive impairment that prevents understanding of the study procedures.
- Participation in structured exercise programs more than twice per week in the last three months.
- Recent fractures or surgeries that limit physical activity.
- Any condition that, in the opinion of the research team, could compromise participant safety or adherence to the protocol.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of a Multi-domain Exercise Program With Motivational Strategies on Anthropometric Variables, Physical Fitness, and Psychological Well-Being of Female Older Adults: A Randomized Controlled Trial
The goal of this clinical trial is to learn whether a long-term exercise program can improve physical health and well-being in older women aged 60 years and older who live in the community.
The main questions this study aims to answer are:
Read more
- Does taking part in a supervised exercise program lower waist size?
- Does the exercise program improve walking speed, leg strength, and the ability to move safely?
- Does the program improve motivation for physical activity and feelings of support and well-being?
Researchers will compare a Supervised Multi-Domain Exercise Program (intervention group) with Usual Daily Activities (No Structured Exercise) (control group) to see whether the supervised exercise program leads to better physical and psychological outcomes.
Participants will:
- Be randomly assigned to either the exercise program or a control group
- Take part in supervised exercise sessions twice a week for 12 months if assigned to the exercise group
- Complete physical tests, body measurements, and questionnaires about motivation and well-being at the start of the study and after 12 months
Read the detailed description
This study is a randomized controlled clinical trial designed to examine the effects of a long-term supervised exercise program on physical and psychological outcomes in older women.
A total of 108 women aged 60 years and older who live independently in the community took part in the study. Participants were randomly assigned to one of two groups using a two-to-one ratio. One group was assigned to the Supervised Multi-Domain Exercise Program (intervention group), and the other group was assigned to Usual Daily Activities (No Structured Exercise) (control group).
Participants in the intervention group took part in supervised exercise sessions twice per week for 12 months. Each session lasted about 45 minutes and included a mix of activities focused on strength, walking and movement, balance, flexibility, and simple thinking tasks. Exercise intensity was adjusted to each participant and monitored throughout the program. Motivational strategies were included to support engagement and long-term participation in physical activity.
Participants in the control group continued their usual daily routines and did not take part in any structured or supervised exercise program during the study period.
All participants completed assessments at the start of the study and again after 12 months. These assessments included physical tests, body measurements, and questionnaires related to motivation and well-being. Trained researchers conducted all assessments using standardized procedures.
The study followed established guidelines for clinical trials and was approved by a local Research Ethics Committee. All participants provided written informed consent before taking part in the study.
- Being tested
- Supervised Multidomain Exercise Program
- Keywords
- Multidomain exercise, Older women, Physical fitness, Motivation for physical activity, Anthropometric variables, Self-Determination Theory, Randomized controlled trial, Exercise intervention
- Medical subject headings
- Overweight, Obesity, Psychological Well-Being
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Supervised Multidomain Exercise ProgramBehavioural
Also called Multidomain Training Program
Participants engaged in a supervised multi-domain exercise program conducted twice per week for 12 months, with each session lasting approximately 45 minutes. The program included neuromotor activities, muscle-strengthening exercises, aerobic training, balance exercises, flexibility activities, and simple cognitive tasks.
Exercise intensity was monitored using the Borg Category-Ratio 10 Rating of Perceived Exertion (CR-10), a simple scale that allows participants to rate how hard the exercise feels, along with an affective valence scale to monitor feelings of comfort or discomfort during exercise. Motivational strategies based on Self-Determination Theory (SDT) were incorporated throughout the intervention to support engagement and long-term participation.
| Study group | Role | What they receive |
|---|---|---|
| Supervised Multidomain Exercise Program | Experimental | Participants allocated to the experimental group participated in a supervised 12-month multi-domain exercise program including strength training, aerobic exercises, balance activities, flexibility, and cognitive tasks, combined with motivational and behavioral strategies. Receives: Behavioral: Supervised Multidomain Exercise Program |
| Usual Daily Activities (No Structured Exercise) | No intervention | Participants allocated to the control group maintained their usual daily routines and did not participate in any structured or supervised exercise program during the study period. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Waist Girth
Change in waist girth after 12 months of intervention, measured in centimeters (cm).
Measured: Baseline and 12 months
Gait Speed (10-Meter Walk Test)
Change in gait speed after 12 months of intervention, assessed using the 10-meter walk test (10MWT), which measures the time needed to walk a distance of 10 meters at a fast and safe pace (seconds).
Measured: Baseline and 12 months
Lower Limb Functional Strength (Five-Times Sit-to-Stand Test)
Change in lower limb functional strength after 12 months of intervention, assessed using the five-times sit-to-stand test (FTSST), which measures the time needed to stand up and sit down five times from a chair (seconds).
Measured: Baseline and 12 months
Functional Mobility (Timed Up and Go Test)
Change in functional mobility after 12 months of intervention, assessed using the Timed Up and Go test (TUG), which measures the time needed to stand up from a chair, walk a short distance, turn around, return, and sit down again (seconds).
Measured: Baseline and 12 months
Secondary outcomes (5)
Autonomous Regulation for Physical Activity
Change in autonomous regulation after 12 months of intervention, assessed using the Treatment Self-Regulation Questionnaire for Physical Activity (TSRQ-PA), a questionnaire that measures reasons for being physically active (score range: 1 to 7).
Measured: Baseline and 12 months
Controlled Regulation for Physical Activity
Change in controlled regulation after 12 months of intervention, assessed using the Treatment Self-Regulation Questionnaire for Physical Activity (TSRQ-PA), which measures externally driven reasons for physical activity (score range: 1 to 7).
Measured: Baseline and 12 months
Amotivation
Change in amotivation after 12 months of intervention, assessed using the Behavioral Regulation in Exercise Questionnaire-3 (BREQ-3), which measures lack of motivation for physical activity (score range: 1 to 5).
Measured: Baseline and 12 months
Basic Psychological Needs Satisfaction
Change in autonomy, competence, and relatedness after 12 months of intervention, assessed using the Basic Need Satisfaction in General Scale (BNSG), which measures satisfaction of basic psychological needs (score range: 1 to 7).
Measured: Baseline and 12 months
Perceived Health Care Climate
Change in perceived autonomy support after 12 months of intervention, assessed using the Health Care Climate Questionnaire (HCCQ), which measures perceived support from health professionals (score range: 1 to 7).
Measured: Baseline and 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Dec 2025
- Study start10 Mar 2023
- Primary completion10 Nov 2024
- Study completion10 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy AgingStudies 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
- Model description
- Parallel-group randomized controlled trial with two arms (experimental and control), with participants allocated in a 2:1 ratio and followed for 12 months.
- Masking
- None (open label)
- Enrolment
- 108 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidade do Oeste de Santa Catarina
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gracielle Fin, Universidade do Oeste de Santa Catarina
- Investigators
- Gracielle Fin, PhD, Principal investigator, Universidade do Oeste de Santa Catarina
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07311265
- Sponsor's protocol ID
- 71244423.0.0000.5367
- Acronym
- MD-EX Women
- Status last verified
- Dec 2025
- First submitted
- 8 Dec 2025
- Last updated
- 30 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of a Multi-domain Exercise Program With Motivational Strategies on Anthropometric Variables, Physical Fitness, and Psychological Well-Being of Female Older Adults: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07311265
- Acronym / sponsor ID
- MD-EX Women / 71244423.0.0000.5367
- Keywords
- Multidomain exercise, Older women, Physical fitness, Motivation for physical activity, Anthropometric variables, Self-Determination Theory, Randomized controlled trial, Exercise intervention
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 108 participants (actual)
- Lead sponsor
- Universidade do Oeste de Santa CatarinaUniversity, hospital or other
- Study start
- 10 Mar 2023 (actual)
- Primary completion
- 10 Nov 2024 (actual)
- Study completion
- 10 Dec 2024 (actual)
- First posted
- 30 Dec 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 learn whether a long-term exercise program can improve physical health and well-being in older women aged 60 years and older who live in the community.
The main questions this study aims to answer are:
- Does taking part in a supervised exercise program lower waist size?
- Does the exercise program improve walking speed, leg strength, and the ability to move safely?
- Does the program improve motivation for physical activity and feelings of support and well-being?
Researchers will compare a Supervised Multi-Domain Exercise Program (intervention group) with Usual Daily Activities (No Structured Exercise) (control group) to see whether the supervised exercise program leads to better physical and psychological outcomes.
Participants will:
- Be randomly assigned to either the exercise program or a control group
- Take part in supervised exercise sessions twice a week for 12 months if assigned to the exercise group
- Complete physical tests, body measurements, and questionnaires about motivation and well-being at the start of the study and after 12 months
Detailed description
This study is a randomized controlled clinical trial designed to examine the effects of a long-term supervised exercise program on physical and psychological outcomes in older women.
A total of 108 women aged 60 years and older who live independently in the community took part in the study. Participants were randomly assigned to one of two groups using a two-to-one ratio. One group was assigned to the Supervised Multi-Domain Exercise Program (intervention group), and the other group was assigned to Usual Daily Activities (No Structured Exercise) (control group).
Participants in the intervention group took part in supervised exercise sessions twice per week for 12 months. Each session lasted about 45 minutes and included a mix of activities focused on strength, walking and movement, balance, flexibility, and simple thinking tasks. Exercise intensity was adjusted to each participant and monitored throughout the program. Motivational strategies were included to support engagement and long-term participation in physical activity.
Participants in the control group continued their usual daily routines and did not take part in any structured or supervised exercise program during the study period.
All participants completed assessments at the start of the study and again after 12 months. These assessments included physical tests, body measurements, and questionnaires related to motivation and well-being. Trained researchers conducted all assessments using standardized procedures.
The study followed established guidelines for clinical trials and was approved by a local Research Ethics Committee. All participants provided written informed consent before taking part in the study.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Parallel-group randomized controlled trial with two arms (experimental and control), with participants allocated in a 2:1 ratio and followed for 12 months.
| Arm | Type | Receives |
|---|---|---|
| Supervised Multidomain Exercise Program | Experimental | Behavioral: Supervised Multidomain Exercise ProgramParticipants allocated to the experimental group participated in a supervised 12-month multi-domain exercise program including strength training, aerobic exercises, balance activities, flexibility, and cognitive tasks, combined with motivational and behavioral strategies. |
| Usual Daily Activities (No Structured Exercise) | No intervention | –Participants allocated to the control group maintained their usual daily routines and did not participate in any structured or supervised exercise program during the study period. |
Who may qualify
- Ages
- 60 to 100 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Women aged 60 years or older.
- Living independently in the community.
- Ability to walk independently, with or without assistive devices.
- Medical clearance to participate in physical exercise.
- Willingness to participate in the exercise program for 12 months.
Key exclusion criteria (5 listed)
- Presence of severe cardiovascular, respiratory, neurological, or musculoskeletal diseases that contraindicate physical exercise.
- Cognitive impairment that prevents understanding of the study procedures.
- Participation in structured exercise programs more than twice per week in the last three months.
- Recent fractures or surgeries that limit physical activity.
- Any condition that, in the opinion of the research team, could compromise participant safety or adherence to the protocol.
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 |
|---|---|---|
| Supervised Multidomain Exercise ProgramAlso: Multidomain Training ProgramParticipants engaged in a supervised multi-domain exercise program conducted twice per week for 12 months, with each session lasting approximately 45 minutes. The program included neuromotor activities, muscle-strengthening exercises, aerobic training, balance exercises, flexibility activities, and simple cognitive tasks. Exercise intensity was monitored using the Borg Category-Ratio 10 Rating of Perceived Exertion (CR-10), a simple scale that allows participants to rate how hard the exercise feels, along with an affective valence scale to monitor feelings of comfort or discomfort during exercise. Motivational strategies based on Self-Determination Theory (SDT) were incorporated throughout the intervention to support engagement and long-term participation. | Behavioural | Supervised Multidomain Exercise Program |
Primary outcome
Waist Girth
Time frame: Baseline and 12 months
Change in waist girth after 12 months of intervention, measured in centimeters (cm).
Gait Speed (10-Meter Walk Test)
Time frame: Baseline and 12 months
Change in gait speed after 12 months of intervention, assessed using the 10-meter walk test (10MWT), which measures the time needed to walk a distance of 10 meters at a fast and safe pace (seconds).
Lower Limb Functional Strength (Five-Times Sit-to-Stand Test)
Time frame: Baseline and 12 months
Change in lower limb functional strength after 12 months of intervention, assessed using the five-times sit-to-stand test (FTSST), which measures the time needed to stand up and sit down five times from a chair (seconds).
Functional Mobility (Timed Up and Go Test)
Time frame: Baseline and 12 months
Change in functional mobility after 12 months of intervention, assessed using the Timed Up and Go test (TUG), which measures the time needed to stand up from a chair, walk a short distance, turn around, return, and sit down again (seconds).
5 secondary outcomes
Autonomous Regulation for Physical Activity
Time frame: Baseline and 12 months
Controlled Regulation for Physical Activity
Time frame: Baseline and 12 months
Amotivation
Time frame: Baseline and 12 months
Basic Psychological Needs Satisfaction
Time frame: Baseline and 12 months
Perceived Health Care Climate
Time frame: Baseline and 12 months
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 30 Dec 2025.
- Individual participant dataSharing planned: No
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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.
Gracielle Fin, PhD principal investigator
Universidade do Oeste de Santa Catarina
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Supervised Multidomain Exercise Program in people with Healthy Aging and Overweight and Obesity, run by Universidade do Oeste de Santa Catarina at 1 site in Brazil.
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 5 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 30 Dec 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 Brazil. 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?
Waist Girth (time frame: Baseline and 12 months). The study lists 4 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 30 Dec 2025.