Older Adults (60 - 85 Years Old)Phase 1NCT07766954
Gymnastics and Multicomponent Training Intervention in Community-dwelling Older Adults
A Phase 1 study testing Multicomponent training intervention Multicomponent training intervention - Protocol includes mobility, resistance exercises for the lower and upper limbs and major muscle groups, and aerobic exercise in people with Older Adults (60 - 85 Years Old), run by Federal University of the Valleys of Jequitinhonha and Mucuri at 1 site in Brazil.
Trial summary
Introduction: Extension projects focused on physical activity can offer health practices and promote quality of life for participants of different ages. Investing in extension projects with a research interface can contribute to relevant insights for teaching knowledge. Read more about this study
- Who is it for?
- Ages 60 to 105 yearsHealthy volunteers can take part
- Conditions the study is for
- Older Adults (60 - 85 Years Old)
- What is being tested?
- Multicomponent training intervention Multicomponent training intervention - Protocol includes mobility, resistance exercises for the lower and upper limbs and major muscle groups, and aerobic exercise
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteBrazil
- Study dates
- 20 Feb 2026to 20 Dec 2028
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
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 105 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Inclusion criteria: Community-dwelling older adults (60 years of age or older), and able to travel to the training center.
Exclusion criteria: Score 7, 8 or 9 on the Clinical Frailty Scale and those with any impediment to performing physical exercise.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Community-based Multicomponent Training and Gymnastics Intervention
Introduction: Extension projects focused on physical activity can offer health practices and promote quality of life for participants of different ages. Investing in extension projects with a research interface can contribute to relevant insights for teaching knowledge. Furthermore, the progressive aging of the population makes it essential to identify individuals at risk of functional decline and to implement evidence-based interventions that allow for the reduction of these losses, enabling a better quality of life for the elderly. The WHO developed the guideline that addresses healthy development, with strategies to promote healthy aging based on solid concepts, with data on their applicability in a real-life scenario, especially from intervention studies. Objective: To evaluate the impact of interventions focused on Gymnastics and multicomponent training on the intrinsic capacity of adult and elderly participants in extension projects at UFBA. Methodology: This is an intervention study within an extension project with a research focus, encompassing adult individuals (participants in MOVEGINBA) and elderly individuals of both sexes, aged 60 years or older (participants in the MOVEGINBA 60+ project). Participants will be evaluated regarding anthropometric, sociodemographic characteristics, health conditions, and physical-functional performance. As well as quality of life, sleep quality, fear of falling, and independence in activities of daily living. Tests and interviews will be conducted before and after the intervention. The results of this study will be fundamental to understanding the implications of the multicomponent gymnastics/training intervention for the participants.
Keywords: Aging; Physical capacity; Gymnastics.
Read the detailed description
University outreach programs should be offered to promote the health and quality of life of the general population, taking into account diverse target audiences. Viewing outreach as an extension of the university into the community, the MOVEGINBA project-registered with PROEXC under number 23132-has been conducted in the Faculty of Education's exercise studio since the first semester of 2025, serving adults, students from various academic programs, and the general public through training activities. Concurrently, the global population is aging rapidly, with significant impacts on economies and healthcare systems. In Brazil, the population aged 65 and older is projected to rise from the current 20 million in 2020 (9.8% of the population) to over 50 million by 2050 (21.8% of the population). Given this scenario, public policies capable of mitigating age-related loss of functional capacity are both urgent and essential. In its report on health and aging, the WHO defined healthy aging as a process requiring the promotion and maintenance of functional capacities that enable individual well-being. Thus, optimizing the health of older adults through strategies that identify high-risk individuals and propose actions to prevent or delay the progression of functional decline appears to be the best approach to reducing the strain on healthcare systems.
In 2017, the WHO published guidelines for healthy development, which address health and well-being and encompass physical activity for individuals. With this perspective in mind, extension activities are encouraged and take place within the university setting, focusing on older adults; to this end, we offer the MOVEGINBA 60+ program-registered with PROEXC under number 23351-which addresses the specific gaps and needs of this demographic. Consequently, gymnastics-based extension projects are conducted at the Federal University of Bahia.
It is essential to understand the implications of such projects for participants regarding emotional health, physical capacity, agility, social interaction, and the intrinsic capacity of older adults. Therefore, this study aims to understand the implications of gymnastics-focused interventions for participants and to analyze their impact on the target population. This initiative is an extension project with a research component-encompassing undergraduate capstone projects and graduate studies-that contributes significantly to people's quality of life.
Conditions: Must be an older adult (over 60 years of age). Must be capable of performing any physical activity independently. Participants may have hypertension, diabetes, or multiple comorbidities, provided they fall within the 1 to 7 range on the Clinical Frailty Scale (ranging from robust to mildly frail).
- Conditions
- Older Adults (60 - 85 Years Old)
- Being tested
- Multicomponent training intervention Multicomponent training intervention - Protocol includes mobility, resistance exercises for the lower and upper limbs and major muscle groups, and aerobic exercise
- Keywords
- Olther adults, Intrinsic Capacity, physical activity., Aging, Physical capacity, Gymnastics
- Medical subject headings
- Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Multicomponent training intervention Multicomponent training intervention - Protocol includes mobility, resistance exercises for the lower and upper limbs and major muscle groups, and aerobic exerciseOther
The interventions will take place twice a week, on two days (Mondays and Wednesdays) with two groups lasting one hour each. The exercises will include joint mobility training, followed by strength training with body weight and the use of elastic bands, dumbbells, sticks, and the like. Subsequently, there will be an aerobic part, lasting 30 minutes, in which the heart rate will be increased, with the use of sound and rhythms. Following this, there will be a cool-down, with a reduction in activities.
Participants will be evaluated before and after the intervention, after 12 weeks, with variables that include intrinsic capacity such as mobility, psychological state, vitality, sensory and cognitive domain.
| Study group | Role | What they receive |
|---|---|---|
| Multicomponent training intervention | Experimental | Multicomponent training intervention - Protocol includes mobility, resistance exercises for the lower and upper limbs and major muscle groups, and aerobic exercises. The intervention will take place twice a week for one hour, following a 12-week protocol. Receives: Other: Multicomponent training intervention Multicomponent training intervention - Protocol includes mobility, resistance exercises for the lower and upper limbs and major muscle groups, and aerobic exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
Intrinsic capacity
Cognition: Montreal Cognitive Assessment - MOCA
Measured: Sample collected before the intervention. Subsequently, another sample was collected 12 weeks after the intervention.
Intrinsic capacity
Mobility: 5-times sit-to-stand test and 6-minutr walk test
Measured: Sample collected before the intervention. Subsequently, another sample was collected 12 weeks after the intervention.
Intrinsic capacity
Psychological:15 itens - Geriatric Depression Scale -GDS-15
Measured: Sample collected before the intervention. Subsequently, another sample was collected 12 weeks after the intervention.
Intrinsic capacity
Vitality: Handgrip strength
Measured: Sample collected before the intervention. Subsequently, another sample was collected 12 weeks after the intervention.
Intrinsic capacity:
Hearing: Self-reported - Self-reported - Participants are asked if they have any hearing problems.
Measured: Sample collected before the intervention. Subsequently, another sample was collected 12 weeks after the intervention.
Intrinsic capacity
Vision: self-reported - Participants are asked if they have any vision problems, if they have difficulty seeing up close or far away, if they have any eye disease, or if they are undergoing medical treatment for diabetes or hypertension.
Measured: Sample collected before the intervention. Subsequently, another sample was collected 12 weeks after the intervention.
Secondary outcomes (1)
Anthropometry
BMI: Weight and height will be used to calculate Body Mass Index.
Measured: Sample collected before the intervention. Subsequently, another sample was collected 12 weeks after the intervention.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Aug 2026
- Study start20 Feb 2026
- Primary completion20 Dec 2027 (estimated)
- Study completion20 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Older Adults (60 - 85 Years Old)Studies 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 1
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Multicomponent training: The interventions will take place twice a week-on Mondays and Wednesdays-in two one-hour sessions. The exercises will include joint mobility training, followed by strength training using body weight and equipment such as resistance bands, dumbbells, and sticks. Next, there will be a 30-minute aerobic segment designed to raise heart rate through the use of music and rhythm. This will be followed by a relaxation period involving a reduction in activity intensity.
- Masking
- None (open label)
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Federal University of the Valleys of Jequitinhonha and Mucuri
- Sponsor type
- University, hospital or other
- Collaborators
- Federal University of Bahia
- Responsible party
- Principal investigator, Marcos Luciano Pimenta Pinheiro, Federal University of the Valleys of Jequitinhonha and Mucuri
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07766954
- Sponsor's protocol ID
- Multicomponent Training
- Status last verified
- Aug 2026
- First submitted
- 26 May 2026
- Last updated
- 17 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Due to participant confidentiality, the data may be shared, but participant identification will not be disclosed.
Study at a glance
From the registry record, last updated by the sponsor on 17 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Community-based Multicomponent Training and Gymnastics Intervention
- ClinicalTrials.gov ID
- NCT07766954
- Acronym / sponsor ID
- Multicomponent Training
- Conditions
- Older Adults (60 - 85 Years Old)
- Keywords
- Olther adults, Intrinsic Capacity, physical activity., Aging, Physical capacity, Gymnastics
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Federal University of the Valleys of Jequitinhonha and MucuriUniversity, hospital or other
- Collaborators
- Federal University of Bahia
- Study start
- 20 Feb 2026 (actual)
- Primary completion
- 20 Dec 2027 (estimated)
- Study completion
- 20 Dec 2028 (estimated)
- First posted
- 17 Aug 2026 (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.
Introduction: Extension projects focused on physical activity can offer health practices and promote quality of life for participants of different ages. Investing in extension projects with a research interface can contribute to relevant insights for teaching knowledge. Furthermore, the progressive aging of the population makes it essential to identify individuals at risk of functional decline and to implement evidence-based interventions that allow for the reduction of these losses, enabling a better quality of life for the elderly. The WHO developed the guideline that addresses healthy development, with strategies to promote healthy aging based on solid concepts, with data on their applicability in a real-life scenario, especially from intervention studies. Objective: To evaluate the impact of interventions focused on Gymnastics and multicomponent training on the intrinsic capacity of adult and elderly participants in extension projects at UFBA. Methodology: This is an intervention study within an extension project with a research focus, encompassing adult individuals (participants in MOVEGINBA) and elderly individuals of both sexes, aged 60 years or older (participants in the MOVEGINBA 60+ project). Participants will be evaluated regarding anthropometric, sociodemographic characteristics, health conditions, and physical-functional performance. As well as quality of life, sleep quality, fear of falling, and independence in activities of daily living. Tests and interviews will be conducted before and after the intervention. The results of this study will be fundamental to understanding the implications of the multicomponent gymnastics/training intervention for the participants.
Keywords: Aging; Physical capacity; Gymnastics.
Detailed description
University outreach programs should be offered to promote the health and quality of life of the general population, taking into account diverse target audiences. Viewing outreach as an extension of the university into the community, the MOVEGINBA project-registered with PROEXC under number 23132-has been conducted in the Faculty of Education's exercise studio since the first semester of 2025, serving adults, students from various academic programs, and the general public through training activities. Concurrently, the global population is aging rapidly, with significant impacts on economies and healthcare systems. In Brazil, the population aged 65 and older is projected to rise from the current 20 million in 2020 (9.8% of the population) to over 50 million by 2050 (21.8% of the population). Given this scenario, public policies capable of mitigating age-related loss of functional capacity are both urgent and essential. In its report on health and aging, the WHO defined healthy aging as a process requiring the promotion and maintenance of functional capacities that enable individual well-being. Thus, optimizing the health of older adults through strategies that identify high-risk individuals and propose actions to prevent or delay the progression of functional decline appears to be the best approach to reducing the strain on healthcare systems.
In 2017, the WHO published guidelines for healthy development, which address health and well-being and encompass physical activity for individuals. With this perspective in mind, extension activities are encouraged and take place within the university setting, focusing on older adults; to this end, we offer the MOVEGINBA 60+ program-registered with PROEXC under number 23351-which addresses the specific gaps and needs of this demographic. Consequently, gymnastics-based extension projects are conducted at the Federal University of Bahia.
It is essential to understand the implications of such projects for participants regarding emotional health, physical capacity, agility, social interaction, and the intrinsic capacity of older adults. Therefore, this study aims to understand the implications of gymnastics-focused interventions for participants and to analyze their impact on the target population. This initiative is an extension project with a research component-encompassing undergraduate capstone projects and graduate studies-that contributes significantly to people's quality of life.
Conditions: Must be an older adult (over 60 years of age). Must be capable of performing any physical activity independently. Participants may have hypertension, diabetes, or multiple comorbidities, provided they fall within the 1 to 7 range on the Clinical Frailty Scale (ranging from robust to mildly frail).
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Multicomponent training: The interventions will take place twice a week-on Mondays and Wednesdays-in two one-hour sessions. The exercises will include joint mobility training, followed by strength training using body weight and equipment such as resistance bands, dumbbells, and sticks. Next, there will be a 30-minute aerobic segment designed to raise heart rate through the use of music and rhythm. This will be followed by a relaxation period involving a reduction in activity intensity.
| Arm | Type | Receives |
|---|---|---|
| Multicomponent training intervention | Experimental | Other: Multicomponent training intervention Multicomponent training intervention - Protocol includes mobility, resistance exercises for the lower and upper limbs and major muscle groups, and aerobic exerciseMulticomponent training intervention - Protocol includes mobility, resistance exercises for the lower and upper limbs and major muscle groups, and aerobic exercises. The intervention will take place twice a week for one hour, following a 12-week protocol. |
Who may qualify
- Ages
- 60 to 105 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
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 |
|---|---|---|
| Multicomponent training intervention Multicomponent training intervention - Protocol includes mobility, resistance exercises for the lower and upper limbs and major muscle groups, and aerobic exerciseThe interventions will take place twice a week, on two days (Mondays and Wednesdays) with two groups lasting one hour each. The exercises will include joint mobility training, followed by strength training with body weight and the use of elastic bands, dumbbells, sticks, and the like. Subsequently, there will be an aerobic part, lasting 30 minutes, in which the heart rate will be increased, with the use of sound and rhythms. Following this, there will be a cool-down, with a reduction in activities. Participants will be evaluated before and after the intervention, after 12 weeks, with variables that include intrinsic capacity such as mobility, psychological state, vitality, sensory and cognitive domain. | Other | Multicomponent training intervention |
Primary outcome
Intrinsic capacity
Time frame: Sample collected before the intervention. Subsequently, another sample was collected 12 weeks after the intervention.
Cognition: Montreal Cognitive Assessment - MOCA
Intrinsic capacity
Time frame: Sample collected before the intervention. Subsequently, another sample was collected 12 weeks after the intervention.
Mobility: 5-times sit-to-stand test and 6-minutr walk test
Intrinsic capacity
Time frame: Sample collected before the intervention. Subsequently, another sample was collected 12 weeks after the intervention.
Psychological:15 itens - Geriatric Depression Scale -GDS-15
Intrinsic capacity
Time frame: Sample collected before the intervention. Subsequently, another sample was collected 12 weeks after the intervention.
Vitality: Handgrip strength
Intrinsic capacity:
Time frame: Sample collected before the intervention. Subsequently, another sample was collected 12 weeks after the intervention.
Hearing: Self-reported - Self-reported - Participants are asked if they have any hearing problems.
Intrinsic capacity
Time frame: Sample collected before the intervention. Subsequently, another sample was collected 12 weeks after the intervention.
Vision: self-reported - Participants are asked if they have any vision problems, if they have difficulty seeing up close or far away, if they have any eye disease, or if they are undergoing medical treatment for diabetes or hypertension.
1 secondary outcome
Anthropometry
Time frame: Sample collected before the intervention. Subsequently, another sample was collected 12 weeks after the intervention.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Aug 2026.
- Related InfoLink provided by the sponsor.
- Individual participant dataSharing planned: No. Due to participant confidentiality, the data may be shared, but participant identification will not be disclosed.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Multicomponent training intervention Multicomponent training intervention - Protocol includes mobility, resistance exercises for the lower and upper limbs and major muscle groups, and aerobic exercise in people with Older Adults (60 - 85 Years Old), run by Federal University of the Valleys of Jequitinhonha and Mucuri 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?
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: enrolling by invitation, as of the sponsor's last update on 17 Aug 2026. 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.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
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?
Intrinsic capacity (time frame: Sample collected before the intervention. Subsequently, another sample was collected 12 weeks after the intervention.). The study lists 6 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 17 Aug 2026.