Effects of Physical Exercise on Frailty, Mental and Physical Health of Older Adults in Rural Areas.
NCT Number: NCT06556537
Acronym: Rural-Frail
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Old Age|Frailty
Interventions: DEVICE: Face-to-face and video-assisted training
Sponsor: Universidad de Zaragoza
Sex: ALL
Age: OLDER_ADULT
Enrollment: 240
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: SINGLE (OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2023-09-01
Completion Date: 2026-08-31
Locations: EXERGNEUD Research Group, Zaragoza, 50009, Spain

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.

Primary Outcome Measures: 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 Outcome Measures: 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., 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., 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., 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., 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., 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., 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., 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., T0 = pre-intervention, T1 = 3 months, and T4 = 12 months.|Muscular strength of the upper limbs., Measured with a handgrip dynamometer., T0 = pre-intervention, T1 = 3 months, and T4 = 12 months.|Muscular strength of the lower limbs., Measured with the stand and sit chair test., T0 = pre-intervention, T1 = 3 months, and T4 = 12 months.|Aerobic capacity., Six minute walk test., T0 = pre-intervention, T1 = 3 months, and T4 = 12 months.|Walking speed., Walking speed measured over 3, 4, and 6 meters., 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., 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., 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., T0 = pre-intervention, T1 = 3 months, and T4 = 12 months|Walking steps., Number of walking steps measured with Global Positioning System., T0 = pre-intervention, T1 = 3 months, and T4 = 12 months.|Walking distance., Total walking distance, in meters, measured with Global Positioning System., T0 = pre-intervention, T1 = 3 months, and T4 = 12 months|Walking speed., Walking speed, in meters per second, measured with Global Positioning System., 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., T0 = pre-intervention, T1 = 3 months, T2 = 6 months, T3 = 9 months, and T4 = 12 months.