Old Age; DebilityNCT06842849
Impact of a Physical Exercise Program in a Rural Area
A study testing Exercise program in people with Old Age; Debility, run by University of Valencia at 1 site in Spain.
Trial summary
With this work we want to assess whether there are differences in the amount of physical activity per week, measured by accelerometry in 3 groups of subjects, where one group (G1) has been carrying out a PA program called "Enguera Sé Saludable" for a year. Read more about this study
- Who is it for?
- Ages 59 years and olderHealthy volunteers can take part
- Conditions the study is for
- Old Age; Debility
- What is being tested?
- Exercise program
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 140 participants
- Where
- 1 siteSpain
- Study dates
- 22 Oct 2025to 31 Dec 2026
- Phase
- Interventional
- 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 59 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Adults over 59 years of age.
- Patients who comply with accelerometer times for 7 days.
- Patients who correctly complete the accelerometer registration sheet.
- Patients who complete the informed consent
Who cannot join
- Patients who do not wear the accelerometer 600 minutes a day for at least 3 days on weekdays and 480 minutes for at least 1 day on the weekend.
- Patients who suffer from illness during data collection.
- Patients who do not wear the accelerometer for 7 days. Be in IPAQ category 1 (low level of AF).
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Spain1 site, 1 recruiting
- Recruiting
Universitat de València
Valencia, 46010
CARMEN GARCÍA GOMARIZ, PhD, 637787861, Carmen.garcia-gomariz@uv.es
CARMEN GARCÍA GOMARIZ, 637787861, Carmen.garcia-gomariz@uv.es
About this study
Official title: Impact of a Physical Exercise Program on the Physical, Podiatric and Mental Health of the Adult Population in a Rural Area
With this work we want to assess whether there are differences in the amount of physical activity per week, measured by accelerometry in 3 groups of subjects, where one group (G1) has been carrying out a PA program called "Enguera Sé Saludable" for a year. another group (G2) newly introduced to the same exercise program, and a control group (G3) that does not carry out an exercise program but declared itself active.
Read the detailed description
Active aging, according to the World Health Organization (WHO), involves making the most of everything that contributes to physical, mental and social well-being throughout life, thus promoting improved quality of life, functionality and longevity in the most advanced stages of life, seeking to minimize disability. To achieve active aging, older people must remain active in all aspects: physical, social and mental. For this reason, the WHO recommends that older adults engage in moderate to vigorous physical activity (MVPA) of 150 minutes a week The objetive, To assess whether there are differences in the amount of MVPA per week, measured by accelerometry in 3 groups of subjects, where one group (G1) had been carrying out a PA program called "Enguera Sé Saludable" for a year, another group (G2 ) newly inserted into the same exercise program, and a control group (G3) that did not carry out an exercise program but declared itself active.
Analytical quasi-experimental study, with 3 groups. A group (G1) over 59 years of age, of both sexes who have been doing PA since the year before the start of the study, within the "Enguera Be Healthy" Program in the municipality of Enguera. Another group (G2) of both sexes, newly enrolled in the same exercise program over 59 years of age. A control group (G3) of 59 years of both sexes who do not carry out the exercise program, inhabitants of Enguera and apparently active. The data analyzed was obtained from the placement of an Actigraph model GT3X BT accelerometer for a week and the collection of data from the various instruments such as the measurement of blood pressure and weight using the Tanita BC Scale. -545N, the Tinetti scale, the Time Up \& Go test, the Monopodal Test, the SPPB test, the Sit to Stand Test, the Borg scale, the IPAQ questionnaire and the FHSQ questionnaire.
- Conditions
- Old Age; Debility
- Being tested
- Exercise program
- Keywords
- old adults, exercise, accelerometry
- Medical subject headings
- Frailty, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Exercise programOther
Multimodal and multicompetent exercise program 2 days a week for 60 minutes and 1 day of walking exercise for 60 minutes.
| Study group | Role | What they receive |
|---|---|---|
| Exercise T0 | Experimental | Carrying out an exercise program one year in progress Receives: Other: Exercise program |
| Exercise T1 | Experimental | Carrying out an exercise program without prior exercise Receives: Other: Exercise program |
| Control | No intervention | Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
MVPA
Mooderate to vigorous amount of activity. Assess the amount of moderate to vigorous exercise during accelerometry for one week.
Measured: 1 year
Secondary outcomes (9)
Up & Go
Evaluate basic mobility in older people and their probable gait and balance disorders. 1. Tell the elderly person to sit in the chair with their back supported by the backrest.
- Ask the person to get up from the chair, walk at a normal pace for a distance of 3 meters, have the person turns around, walks back to the chair and sits down again. 3. Measure the time the older person takes the test. Timing begins when the person He starts to get up from the chair and ends when he returns to the chair and sits down.
- Give a test try Normal: <10 seconds.
- Mild mobility disability: 11-13 seconds.
- High risk of falls: >13 seconds
Measured: 1 year
Tinetti
Test that analyzes certain variables to evaluate gait and balance. The higher the score, the better the performance. The highest score of the gait subscale is 12, for balance 16. The sum of both scores for fall risk. The higher the score>the lower the risk <19 High risk of falls
Measured: 1 year
SPBB
Short Physical Performance Battery is an instrument that evaluates three aspects of mobility: balance, walking speed and strength of movement.
limbs or lower extremities to get up from a chair. Supports the probable detection of outcomes adverse events such as mortality and institutionalization, as well as their association with disability.
Measured: 1 YEAR
Sit to Stand Test
Assesses the functional strength of the lower limbs, A chair was required on a flat surface and the subject was asked not to lean on his arms to get up and sit down, therefore, he was given a test opportunity with the instruction not to lean on. The patient is informed that the test consists of performing as many repetitions as possible of getting up and sitting down in a chair during a period of 60 seconds and that the time elapsed to the tenth repetition of getting up and sitting down will be timed at the same time. .
Measured: 1 year
IPAQ
To estimate the level of mobility of older people. It includes seven questions that ask how often, for how long, and with what intensity the individual performed both moderate and vigorous activities during the past week, questions about time spent walking, and time spent sitting.
Measured: 1 year
FHSQ
Specific to foot health, measuring quality of life based on foot pain, functional competence, footwear, and overall foot health. The first section consists of 13 questions measuring. The second section consists of 20 questions with Likert-type responses in 4 items. In the last section, the individual's sociodemographic information is collected. Regarding the interpretation of the results, given that the questionnaire does not provide a total score, the individual's responses must be entered into a computer application that will quantify a score from 0 to 100, with 0 being the worst state of health and 100 being the best.
Measured: 1 year
Bood pressure
systolic and diastolic blood pressure measurement
Measured: 1 year
Sex
Sex
Measured: o week , basaline
BMC
Body mass index
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Feb 2025
- Study start22 Oct 2025
- Primary completion30 Jul 2026
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Old Age; DebilityStudies 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
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 140 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Valencia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, CARMEN GARCÍA GOMARIZ, University of Valencia
- Investigators
- CARMEN GARCÍA GOMARIZ, Principal investigator, UNIVERSITAT DE VALÉNCIA DEPARTAMENTO D'INFERMERIA
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06842849
- Sponsor's protocol ID
- ESS_01
- Status last verified
- Sep 2026
- First submitted
- 18 Feb 2025
- Last updated
- 11 Sep 2026
- 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 11 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of a Physical Exercise Program on the Physical, Podiatric and Mental Health of the Adult Population in a Rural Area
- ClinicalTrials.gov ID
- NCT06842849
- Acronym / sponsor ID
- ESS_01
- Conditions
- Old Age; Debility
- Keywords
- old adults, exercise, accelerometry
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 140 participants (estimated)
- Lead sponsor
- University of ValenciaUniversity, hospital or other
- Study start
- 22 Oct 2025 (actual)
- Primary completion
- 30 Jul 2026 (actual)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 24 Feb 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.
With this work we want to assess whether there are differences in the amount of physical activity per week, measured by accelerometry in 3 groups of subjects, where one group (G1) has been carrying out a PA program called "Enguera Sé Saludable" for a year. another group (G2) newly introduced to the same exercise program, and a control group (G3) that does not carry out an exercise program but declared itself active.
Detailed description
Active aging, according to the World Health Organization (WHO), involves making the most of everything that contributes to physical, mental and social well-being throughout life, thus promoting improved quality of life, functionality and longevity in the most advanced stages of life, seeking to minimize disability. To achieve active aging, older people must remain active in all aspects: physical, social and mental. For this reason, the WHO recommends that older adults engage in moderate to vigorous physical activity (MVPA) of 150 minutes a week The objetive, To assess whether there are differences in the amount of MVPA per week, measured by accelerometry in 3 groups of subjects, where one group (G1) had been carrying out a PA program called "Enguera Sé Saludable" for a year, another group (G2 ) newly inserted into the same exercise program, and a control group (G3) that did not carry out an exercise program but declared itself active.
Analytical quasi-experimental study, with 3 groups. A group (G1) over 59 years of age, of both sexes who have been doing PA since the year before the start of the study, within the "Enguera Be Healthy" Program in the municipality of Enguera. Another group (G2) of both sexes, newly enrolled in the same exercise program over 59 years of age. A control group (G3) of 59 years of both sexes who do not carry out the exercise program, inhabitants of Enguera and apparently active. The data analyzed was obtained from the placement of an Actigraph model GT3X BT accelerometer for a week and the collection of data from the various instruments such as the measurement of blood pressure and weight using the Tanita BC Scale. -545N, the Tinetti scale, the Time Up \& Go test, the Monopodal Test, the SPPB test, the Sit to Stand Test, the Borg scale, the IPAQ questionnaire and the FHSQ questionnaire.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Exercise T0 | Experimental | Other: Exercise programCarrying out an exercise program one year in progress |
| Exercise T1 | Experimental | Other: Exercise programCarrying out an exercise program without prior exercise |
| Control | No intervention | –Control |
Who may qualify
- Ages
- 59 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Adults over 59 years of age.
- Patients who comply with accelerometer times for 7 days.
- Patients who correctly complete the accelerometer registration sheet.
- Patients who complete the informed consent
Key exclusion criteria (3 listed)
- Patients who do not wear the accelerometer 600 minutes a day for at least 3 days on weekdays and 480 minutes for at least 1 day on the weekend.
- Patients who suffer from illness during data collection.
- Patients who do not wear the accelerometer for 7 days. Be in IPAQ category 1 (low level of AF).
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 |
|---|---|---|
| Exercise programMultimodal and multicompetent exercise program 2 days a week for 60 minutes and 1 day of walking exercise for 60 minutes. | Other | Exercise T0, Exercise T1 |
Primary outcome
MVPA
Time frame: 1 year
Mooderate to vigorous amount of activity. Assess the amount of moderate to vigorous exercise during accelerometry for one week.
9 secondary outcomes
Up & Go
Time frame: 1 year
Tinetti
Time frame: 1 year
SPBB
Time frame: 1 YEAR
Sit to Stand Test
Time frame: 1 year
IPAQ
Time frame: 1 year
FHSQ
Time frame: 1 year
Bood pressure
Time frame: 1 year
Sex
Time frame: o week , basaline
BMC
Time frame: 1 year
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 11 Sep 2026.
- 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.
CARMEN GARCÍA GOMARIZ principal investigator
UNIVERSITAT DE VALÉNCIA DEPARTAMENTO D'INFERMERIA
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Exercise program in people with Old Age; Debility, run by University of Valencia at 1 site in Spain.
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 4 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: looking for participants now, as of the sponsor's last update on 11 Sep 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 Spain. 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?
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?
Contact CARMEN GARCÍA GOMARIZ, Phd (637787861, Carmen.garcia-gomariz@uv.es), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
MVPA (time frame: 1 year). 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 11 Sep 2026.