Clinical trial NCT06556537: Effects of Physical Exercise on Frailty, Mental and Physical Health of Older Adults in Rural Areas.
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.
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Old Age
Frailty
Keywords: Exercise
Rural areas
Lead sponsor: Universidad de Zaragoza
Sponsor class: OTHER
First posted: 2024-08-16
Enrollment: 240
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: Frailty status.
timeFrame: T0 = pre-intervention, T1 = 3 months, T2 = 6 months, T3 = 9 months, and T4 = 12 months.
Secondary outcomes:
measure: Frailty.
timeFrame: T0 = pre-intervention, T1 = 3 months, T2 = 6 months, T3 = 9 months, and T4 = 12 months.
measure: Power Frail App.
timeFrame: T0 = pre-intervention, T1 = 3 months, T2 = 6 months, T3 = 9 months, and T4 = 12 months.
measure: Cognitive impairment.
timeFrame: T0 = pre-intervention, T1 = 3 months, T2 = 6 months, T3 = 9 months, and T4 = 12 months.
measure: Mental health and depression.
timeFrame: T0 = pre-intervention, T1 = 3 months, and T4 = 12 months
measure: Quality of life of participants EuroQol-5D.
timeFrame: T0 = pre-intervention, T1 = 3 months, and T4 = 12 months
measure: Trail Making Test (TMT).
timeFrame: T0 = pre-intervention, T1 = 3 months, T2 = 6 months, T3 = 9 months, and T4 = 12 months.
measure: DeJong Gierveld Loneliness Scale.
timeFrame: T0 = pre-intervention, T1 = 3 months, and T4 = 12 months.
measure: The Aging Self-Efficacy Scale.
timeFrame: T0 = pre-intervention, T1 = 3 months, and T4 = 12 months.
measure: Muscular strength of the upper limbs.
timeFrame: T0 = pre-intervention, T1 = 3 months, and T4 = 12 months.
measure: Muscular strength of the lower limbs.
timeFrame: T0 = pre-intervention, T1 = 3 months, and T4 = 12 months.
measure: Aerobic capacity.
timeFrame: T0 = pre-intervention, T1 = 3 months, and T4 = 12 months.
measure: Walking speed.
timeFrame: T0 = pre-intervention, T1 = 3 months, T2 = 6 months, T3 = 9 months, and T4 = 12 months.
measure: SARC-F Questionnaire.
timeFrame: T0 = pre-intervention, T1 = 3 months, and T4 = 12 months
measure: Body composition - Fat mass and Fat-Free mass.
timeFrame: T0 = pre-intervention, T1 = 3 months, and T4 = 12 months.
measure: Objective physical activity levels (minutes and intensities)
timeFrame: T0 = pre-intervention, T1 = 3 months, and T4 = 12 months
measure: Walking steps.
timeFrame: T0 = pre-intervention, T1 = 3 months, and T4 = 12 months.
measure: Walking distance.
timeFrame: T0 = pre-intervention, T1 = 3 months, and T4 = 12 months
measure: Walking speed.
timeFrame: T0 = pre-intervention, T1 = 3 months, and T4 = 12 months.
measure: Physical activity levels
timeFrame: T0 = pre-intervention, T1 = 3 months, T2 = 6 months, T3 = 9 months, and T4 = 12 months.
Other outcomes:
Locations:
city: Zaragoza
country: Spain
facility: EXERGNEUD Research Group
Study officials:
affiliation: University of Zaragoza - EXERGENUD Research Group
name: Angel Matute-Llorente, PhD
role: PRINCIPAL_INVESTIGATOR
References: