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NCT06556537: Rural-Frail
Effects of Physical Exercise on Frailty, Mental and Physical Health of Older Adults in Rural Areas.
NA trial testing Face-to-face and video-assisted training in Old Age in 240 participants. Currently enrolling.
30 June 2025
Quick facts
| Lead sponsor | Universidad de Zaragoza |
|---|---|
| Phase | NA |
| Status | Recruiting now |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | single |
| Primary purpose | treatment |
| Enrollment | 240 |
| Start date | 1 September 2023 |
| Primary completion | 30 June 2025 |
| Estimated completion | 31 August 2026 |
| Sites | 1 location across Spain |
Drugs / interventions tested
- Face-to-face and video-assisted training
Conditions studied
Sponsor
Universidad de Zaragoza — full company profile →
Who can join
65 and older, any sex, with Old Age or Frailty. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
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.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT06556537
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT06556537 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Universidad de Zaragoza
- Last refreshed: 16 August 2024
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