Old AgeRural-FrailNCT06556537
Effects of Physical Exercise on Frailty, Mental and Physical Health of Older Adults in Rural Areas.
A study testing Face-to-face and video-assisted training in people with Old Age and Frailty, run by Universidad de Zaragoza at 1 site in Spain.
Trial summary
Global aging is a significant challenge, both economically and in terms of public health. One of the main challenges is to maintain the health and functionality of older adults. Physical exercise has been suggested as one of the best non-pharmacological tools to prevent health and functionality loss. Read more about this study
- Who is it for?
- Ages 65 years and olderHealthy volunteers can take part
- What is being tested?
- Face-to-face and video-assisted training
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 240 participants
- Where
- 1 siteSpain
- Study dates
- 1 Sep 2023to 31 Aug 2027
- 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 65 years and older
- All sexes
- Healthy volunteers accepted
- Older adult
Who may be able to join
- Age equal to or greater than 65 years.
- Be able to provide informed consent voluntarily.
- Walk autonomously.
- Have a score of 4 points or more on the Short Physical Performance Battery (SPPB).
Who cannot join
- Those that have to do with contraindications for performing physical exercise:
- Recent acute myocardial infarction within the last 3-6 months or unstable angina.
- Uncontrolled atrial or ventricular arrhythmias.
- Dissecting aortic aneurysm.
- Severe aortic stenosis.
- Acute endocarditis or pericarditis.
Show all 14Show fewer
- Uncontrolled arterial hypertension (>180/100 mmHg).
- Acute thromboembolic disease.
- Acute and severe heart or respiratory failure.
- Recent bone fracture, orthostatic hypotension.
- Diabetes or uncontrolled hypoglycemia.
- Any pathology that causes a significant functional limitation such as advanced Parkinson's, considerable vision or hearing problems Cancer, or autoimmune disease.
- People scoring less than 4 on the SPPB (dependents).
- Any pathology or circumstance that the primary care team considers counterproductive to participation in physical exercise.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of Face-to-face and Video-assisted Physical Exercise Sessions on Frailty, Mental and Physical Health of Older Adults in Rural Areas.
Global aging is a significant challenge, both economically and in terms of public health. One of the main challenges is to maintain the health and functionality of older adults. Physical exercise has been suggested as one of the best non-pharmacological tools to prevent health and functionality loss. However, existing scientific literature has mainly focused on older adults from urban centers. There are no studies focused on older people in rural areas, who have particular characteristics.
The present project aims to evaluate the effects of a face-to-face and video-assisted intervention, which incorporates multi-component physical exercise with different motivational strategies, on the mental health, physical function, and frailty of individuals over 65 years of age residing in rural areas. Additionally, it aims to determine the effectiveness, safety, and adherence of new technologies in carrying out an intervention that includes multi-component physical exercise, cognitive work, and motivational strategies through video assistance for older women and men living in rural areas.
Read more
A randomized controlled trial will be conducted, involving 240 people over the age of 65 who will be randomly divided into two groups. One group, the intervention group, will participate in a face-to-face multicomponent physical exercise program three times a week for 60 minutes per session over 12 weeks. After that, the intervention will continue through video-assisted sessions for the remaining nine months, divided into three blocks of two months of rest and one video-assisted intervention. The control group will continue with their usual daily activities but receive recommendations for physical activity and mental and physical health talks. Both groups will undergo a battery of tests to evaluate the effects of the interventions. The primary variable measured will be functional capacity, assessed through the Short Physical Performance Battery. Secondary variables will include health-related physical condition (Power frail app), cognitive function (Trail making test), and quality of life, among others.
The results expected from this study will be of significant scientific and technical importance in the field of psycho-socio-health. Consequently, the project is of utmost importance, not only to enhance the health of the rural population but also to promote individual and social sustainability.
- Being tested
- Face-to-face and video-assisted training
- Keywords
- Exercise, Rural areas
- 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.
Face-to-face and video-assisted trainingDevice
Also called Exercise
During the first phase, the intervention group will receive face-to-face training over 12 weeks. Each session will last 60 minutes, and there will be five sessions per week, with three supervised and two unsupervised.
In the second phase, there will be 60 work sessions, divided into blocks of four weeks on three occasions, with one month of exercise and two months of non-exercise over the remaining 9 months. This phase will be conducted via video assistance. Each session will include a warm-up of 10-15 minutes, a main part of 20-40 minutes, and a cool-down of 10-15 minutes.
| Study group | Role | What they receive |
|---|---|---|
| Intervention group | Experimental | Participants will undergo a face-to-face and video-assisted physical exercise intervention. Receives: Device: Face-to-face and video-assisted training |
| Control group | No intervention | Participants in the control group will maintain their usual lifestyle throughout the project. They will receive physical activity recommendations for older people and will attend monthly health promotion meetings. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Frailty status.
Frailty status measured with the Short Physical Performance Battery (SPPB). The minimum value is 0 and the maximum value is 12 points. A score of < 10 points means frailty. Therefore, a higher score means a better outcome.
Measured: T0 = pre-intervention, T1 = 3 months, T2 = 6 months, T3 = 9 months, and T4 = 12 months.
Secondary outcomes (19)
Frailty.
Frailty status measured with the Frailty Trait Scale (FTS). The minimum value for the 5-item FTS is 0 and the maximum value is 50 points. Frail participants are those with FTS5 scores > 25 points. Therefore, a higher score means a worse outcome.
Measured: T0 = pre-intervention, T1 = 3 months, T2 = 6 months, T3 = 9 months, and T4 = 12 months.
Power Frail App.
App designed to assess muscle power and frailty in older adults.
Measured: T0 = pre-intervention, T1 = 3 months, T2 = 6 months, T3 = 9 months, and T4 = 12 months.
Cognitive impairment.
Cognitive impairment measured with the Mini Mental State Examination (MMSE) test. The minimum value is 0 and the maximum value is 30 points. Any score of 24 or more indicates a normal cognition. Therefore, higher scores indicate a worse outcome.
Measured: T0 = pre-intervention, T1 = 3 months, T2 = 6 months, T3 = 9 months, and T4 = 12 months.
Mental health and depression.
Mental health and depression measured with the Geriatric Depression Scale. The minimum value is 0 and the maximum value is 15 points. A score of > 5 suggests depression. Therefore, higher scores mean a worse outcome.
Measured: T0 = pre-intervention, T1 = 3 months, and T4 = 12 months
Quality of life of participants EuroQol-5D.
Quality of life measured with the EuroQol-5D. The minimum value is 0 and the maximum value is 1. A higher score means a better outcome.
Measured: T0 = pre-intervention, T1 = 3 months, and T4 = 12 months
Trail Making Test (TMT).
Speed for attention, sequencing, mental flexibility visual search and motor function measured with the TMT parts A \& B. There is no maximum value or minimum value. In the part A, a score of > 78 seconds suggests deficiency. In the part B is > 273 seconds. Results for both are reported as the number of seconds required to complete the task; therefore, higher scores reveal greater impairment.
Measured: T0 = pre-intervention, T1 = 3 months, T2 = 6 months, T3 = 9 months, and T4 = 12 months.
DeJong Gierveld Loneliness Scale.
Emotional and social loneliness measured with the DeJong Gierveld Loneliness Scale. The minimum value is 0 and the maximum value is 6 points. This gives a possible range of scores from 0 to 6, which can be read as follows: 0 = (Least lonely) and 6 = (Most lonely). Therefore, higher scores mean a worse outcome.
Measured: T0 = pre-intervention, T1 = 3 months, and T4 = 12 months.
The Aging Self-Efficacy Scale.
The perceived level of control that elderly individuals have over the aspects, content, and outcomes of aging measured with the Aging Self-Efficacy Scale. The minimum value is 10 and the maximum value is 40 points. A higher score means a better outcome.
Measured: T0 = pre-intervention, T1 = 3 months, and T4 = 12 months.
Muscular strength of the upper limbs.
Measured with a handgrip dynamometer.
Measured: T0 = pre-intervention, T1 = 3 months, and T4 = 12 months.
Muscular strength of the lower limbs.
Measured with the stand and sit chair test.
Measured: T0 = pre-intervention, T1 = 3 months, and T4 = 12 months.
Aerobic capacity.
Six minute walk test.
Measured: T0 = pre-intervention, T1 = 3 months, and T4 = 12 months.
Walking speed.
Walking speed measured over 3, 4, and 6 meters.
Measured: T0 = pre-intervention, T1 = 3 months, T2 = 6 months, T3 = 9 months, and T4 = 12 months.
SARC-F Questionnaire.
Sarcopenia measured with the SARC-F questionnaire. The minimum value is 0 and the maximum value is 10 points. A score of 4 points or more indicates a high risk of sarcopenia. Therefore, higher scores mean a worse outcome.
Measured: T0 = pre-intervention, T1 = 3 months, and T4 = 12 months
Body composition - Fat mass and Fat-Free mass.
Body fat measured with bioelectrical impedance analysis.
Measured: T0 = pre-intervention, T1 = 3 months, and T4 = 12 months.
Objective physical activity levels (minutes and intensities)
Physical activity levels registered with triaxial accelerometers that they will wear during 7 days.
Measured: T0 = pre-intervention, T1 = 3 months, and T4 = 12 months
Walking steps.
Number of walking steps measured with Global Positioning System.
Measured: T0 = pre-intervention, T1 = 3 months, and T4 = 12 months.
Walking distance.
Total walking distance, in meters, measured with Global Positioning System.
Measured: T0 = pre-intervention, T1 = 3 months, and T4 = 12 months
Walking speed.
Walking speed, in meters per second, measured with Global Positioning System.
Measured: T0 = pre-intervention, T1 = 3 months, and T4 = 12 months.
Physical activity levels
Physical activity levels measures with Physical Activity Scale for the Elderly (PASE). It uses frequency, duration, and intensity level of activity over the previous week to assign a score, ranging from 0 to 793, with higher scores indicating greater physical activity.
Measured: T0 = pre-intervention, T1 = 3 months, T2 = 6 months, T3 = 9 months, and T4 = 12 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Aug 2024
- Study start1 Sep 2023
- Primary completion20 Dec 2026 (estimated)
- Study completion31 Aug 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Old AgeStudies 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 240 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universidad de Zaragoza
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ángel Matute-Llorente, Universidad de Zaragoza
- Investigators
- Angel Matute-Llorente, PhD, Principal investigator, University of Zaragoza - EXERGENUD Research Group
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06556537
- Sponsor's protocol ID
- PID2022-140622OA-I00.
- Acronym
- Rural-Frail
- Status last verified
- May 2026
- First submitted
- 21 Jul 2024
- Last updated
- 18 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Face-to-face and Video-assisted Physical Exercise Sessions on Frailty, Mental and Physical Health of Older Adults in Rural Areas.
- ClinicalTrials.gov ID
- NCT06556537
- Acronym / sponsor ID
- Rural-Frail / PID2022-140622OA-I00.
- Keywords
- Exercise, Rural areas
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 240 participants (estimated)
- Lead sponsor
- Universidad de ZaragozaUniversity, hospital or other
- Study start
- 1 Sep 2023 (actual)
- Primary completion
- 20 Dec 2026 (estimated)
- Study completion
- 31 Aug 2027 (estimated)
- First posted
- 16 Aug 2024 (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.
Global aging is a significant challenge, both economically and in terms of public health. One of the main challenges is to maintain the health and functionality of older adults. Physical exercise has been suggested as one of the best non-pharmacological tools to prevent health and functionality loss. However, existing scientific literature has mainly focused on older adults from urban centers. There are no studies focused on older people in rural areas, who have particular characteristics.
The present project aims to evaluate the effects of a face-to-face and video-assisted intervention, which incorporates multi-component physical exercise with different motivational strategies, on the mental health, physical function, and frailty of individuals over 65 years of age residing in rural areas. Additionally, it aims to determine the effectiveness, safety, and adherence of new technologies in carrying out an intervention that includes multi-component physical exercise, cognitive work, and motivational strategies through video assistance for older women and men living in rural areas.
A randomized controlled trial will be conducted, involving 240 people over the age of 65 who will be randomly divided into two groups. One group, the intervention group, will participate in a face-to-face multicomponent physical exercise program three times a week for 60 minutes per session over 12 weeks. After that, the intervention will continue through video-assisted sessions for the remaining nine months, divided into three blocks of two months of rest and one video-assisted intervention. The control group will continue with their usual daily activities but receive recommendations for physical activity and mental and physical health talks. Both groups will undergo a battery of tests to evaluate the effects of the interventions. The primary variable measured will be functional capacity, assessed through the Short Physical Performance Battery. Secondary variables will include health-related physical condition (Power frail app), cognitive function (Trail making test), and quality of life, among others.
The results expected from this study will be of significant scientific and technical importance in the field of psycho-socio-health. Consequently, the project is of utmost importance, not only to enhance the health of the rural population but also to promote individual and social sustainability.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention group | Experimental | Device: Face-to-face and video-assisted trainingParticipants will undergo a face-to-face and video-assisted physical exercise intervention. |
| Control group | No intervention | –Participants in the control group will maintain their usual lifestyle throughout the project. They will receive physical activity recommendations for older people and will attend monthly health promotion meetings. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (4 listed)
- Age equal to or greater than 65 years.
- Be able to provide informed consent voluntarily.
- Walk autonomously.
- Have a score of 4 points or more on the Short Physical Performance Battery (SPPB).
Key exclusion criteria (14 listed)
- Recent acute myocardial infarction within the last 3-6 months or unstable angina.
- Uncontrolled atrial or ventricular arrhythmias.
- Dissecting aortic aneurysm.
- Severe aortic stenosis.
- Acute endocarditis or pericarditis.
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 |
|---|---|---|
| Face-to-face and video-assisted trainingAlso: ExerciseDuring the first phase, the intervention group will receive face-to-face training over 12 weeks. Each session will last 60 minutes, and there will be five sessions per week, with three supervised and two unsupervised. In the second phase, there will be 60 work sessions, divided into blocks of four weeks on three occasions, with one month of exercise and two months of non-exercise over the remaining 9 months. This phase will be conducted via video assistance. Each session will include a warm-up of 10-15 minutes, a main part of 20-40 minutes, and a cool-down of 10-15 minutes. | Device | Intervention group |
Primary outcome
Frailty status.
Time frame: T0 = pre-intervention, T1 = 3 months, T2 = 6 months, T3 = 9 months, and T4 = 12 months.
Frailty status measured with the Short Physical Performance Battery (SPPB). The minimum value is 0 and the maximum value is 12 points. A score of < 10 points means frailty. Therefore, a higher score means a better outcome.
19 secondary outcomes
Frailty.
Time frame: T0 = pre-intervention, T1 = 3 months, T2 = 6 months, T3 = 9 months, and T4 = 12 months.
Power Frail App.
Time frame: T0 = pre-intervention, T1 = 3 months, T2 = 6 months, T3 = 9 months, and T4 = 12 months.
Cognitive impairment.
Time frame: T0 = pre-intervention, T1 = 3 months, T2 = 6 months, T3 = 9 months, and T4 = 12 months.
Mental health and depression.
Time frame: T0 = pre-intervention, T1 = 3 months, and T4 = 12 months
Quality of life of participants EuroQol-5D.
Time frame: T0 = pre-intervention, T1 = 3 months, and T4 = 12 months
Trail Making Test (TMT).
Time frame: T0 = pre-intervention, T1 = 3 months, T2 = 6 months, T3 = 9 months, and T4 = 12 months.
DeJong Gierveld Loneliness Scale.
Time frame: T0 = pre-intervention, T1 = 3 months, and T4 = 12 months.
The Aging Self-Efficacy Scale.
Time frame: T0 = pre-intervention, T1 = 3 months, and T4 = 12 months.
Muscular strength of the upper limbs.
Time frame: T0 = pre-intervention, T1 = 3 months, and T4 = 12 months.
Muscular strength of the lower limbs.
Time frame: T0 = pre-intervention, T1 = 3 months, and T4 = 12 months.
Aerobic capacity.
Time frame: T0 = pre-intervention, T1 = 3 months, and T4 = 12 months.
Walking speed.
Time frame: T0 = pre-intervention, T1 = 3 months, T2 = 6 months, T3 = 9 months, and T4 = 12 months.
SARC-F Questionnaire.
Time frame: T0 = pre-intervention, T1 = 3 months, and T4 = 12 months
Body composition - Fat mass and Fat-Free mass.
Time frame: T0 = pre-intervention, T1 = 3 months, and T4 = 12 months.
Objective physical activity levels (minutes and intensities)
Time frame: T0 = pre-intervention, T1 = 3 months, and T4 = 12 months
Walking steps.
Time frame: T0 = pre-intervention, T1 = 3 months, and T4 = 12 months.
Walking distance.
Time frame: T0 = pre-intervention, T1 = 3 months, and T4 = 12 months
Walking speed.
Time frame: T0 = pre-intervention, T1 = 3 months, and T4 = 12 months.
Physical activity levels
Time frame: T0 = pre-intervention, T1 = 3 months, T2 = 6 months, T3 = 9 months, and T4 = 12 months.
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 18 May 2026.
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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.
Angel Matute-Llorente, PhD principal investigator
University of Zaragoza - EXERGENUD Research Group
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Face-to-face and video-assisted training in people with Old Age and Frailty, run by Universidad de Zaragoza 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 14 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: under way, not looking for participants, as of the sponsor's last update on 18 May 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?
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?
Frailty status. (time frame: T0 = pre-intervention, T1 = 3 months, T2 = 6 months, T3 = 9 months, and T4 = 12 months.). 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 18 May 2026.