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

NCT06556537 | Active Not Recruiting DMC

• 1 other identifier: PID2022-140622OA-I00.
• Study Type: interventional
• Target: 240
• Locations: 1 country
• Sites: 1

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

Keywords

Exercise; Rural areas

Outcome Measures

Primary Outcomes (1)

• 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.

  T0 = pre-intervention, T1 = 3 months, T2 = 6 months, T3 = 9 months, and T4 = 12 months.

Secondary Outcomes (19)

• Frailty.

  T0 = pre-intervention, T1 = 3 months, T2 = 6 months, T3 = 9 months, and T4 = 12 months.

• Power Frail App.

  T0 = pre-intervention, T1 = 3 months, T2 = 6 months, T3 = 9 months, and T4 = 12 months.

• Cognitive impairment.

  T0 = pre-intervention, T1 = 3 months, T2 = 6 months, T3 = 9 months, and T4 = 12 months.

• Mental health and depression.

  T0 = pre-intervention, T1 = 3 months, and T4 = 12 months

• Quality of life of participants EuroQol-5D.

  T0 = pre-intervention, T1 = 3 months, and T4 = 12 months

Study Arms (2)

Intervention group

EXPERIMENTAL

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

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.

Interventions

Face-to-face and video-assisted training 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.

Also known as: Exercise

Intervention group

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Universidad de Zaragoza: lead

Study Sites (1)

EXERGNEUD Research Group

Zaragoza, 50009, Spain

Location

MeSH Terms

Conditions

Frailty; Motor Activity

Interventions

Exercise Therapy

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms; Behavior

Intervention Hierarchy (Ancestors)

Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Therapeutics; Physical Therapy Modalities

Study Officials

• Angel Matute-Llorente, PhD

  University of Zaragoza - EXERGENUD Research Group

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: The statistician will only have codes but in the database but will not know which code corresponds to which group
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: July 21, 2024
• First Posted: August 16, 2024
• Study Start: September 1, 2023
• Primary Completion (Estimated): December 20, 2026
• Study Completion (Estimated): August 31, 2027
• Last Updated: May 18, 2026

Record last verified: 2026-05

Locations

ES (1)