Effects of Physical Exercise on Frailty, Mental and Physical Health of Older Adults in Rural Areas.

NCT ID: NCT06556537

Last Updated: 2024-08-16

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 240 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-09-01
• Study Completion Date: 2026-08-31

Brief 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. 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.

Conditions

Old Age; Frailty

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Intervention group

Participants will undergo a face-to-face and video-assisted physical exercise intervention.

Group Type: EXPERIMENTAL

Face-to-face and video-assisted training

Intervention Type: DEVICE

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.

Control group

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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Face-to-face and video-assisted training

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.

Intervention Type: DEVICE

Other Intervention Names

Exercise

Eligibility Criteria

Inclusion Criteria

• 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).

Exclusion Criteria

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.
• 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.

• Minimum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Universidad de Zaragoza

OTHER

Sponsor Role: lead

Responsible Party

Ángel Matute-Llorente

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Angel Matute-Llorente, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Zaragoza - EXERGENUD Research Group

Locations

EXERGNEUD Research Group

Zaragoza, , Spain

Site Status: RECRUITING

Countries

Spain

Central Contacts

Ángel Matute-Llorente, PhD

Role: CONTACT

amatute@unizar.es

+34876553755

Facility Contacts

Angel Matute-Llorente, PhD

Role: primary

amatute@unizar.es

+34876553755

Other Identifiers

PID2022-140622OA-I00.

Identifier Type: -

Identifier Source: org_study_id