Assessing frailty and muscle quality in older adults through exercise
Development of Continuous Assessment of Muscle Quality and Frailty in Older Subjects Using Multi-parametric Combinations of Ultrasound and Blood Biomarkers: a Study Protocol for a Quasi-experimental Multi-center Study (ECOFRAIL Study)
NA · University of Deusto · NCT05294757
This study is testing a new exercise program to see if it helps older adults who are frail improve their muscle quality and physical performance.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 200 (estimated) |
| Ages | 65 Years and up |
| Sex | All |
| Sponsor | University of Deusto (other) |
| Locations | 3 sites (Albacete, Castilla La Mancha and 2 other locations) |
| Trial ID | NCT05294757 on ClinicalTrials.gov |
What this trial studies
This study aims to evaluate the effectiveness of a physical exercise intervention program for elderly individuals experiencing frailty. It will utilize a combination of ultrasound and blood-based biomarkers to assess muscle quality and monitor changes over time. The study will recruit 200 participants aged 70 and older from both hospital and primary care settings, with evaluations conducted at baseline and follow-up. The primary goal is to compare physical performance and frailty assessments before and after the exercise program.
Who should consider this trial
Good fit: Ideal candidates for this study are individuals aged 70 and older who are experiencing frailty but are capable of providing informed consent and performing functional tests.
Not a fit: Patients with severe cognitive impairment or those who are already engaged in regular exercise programs may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved physical function and quality of life for frail older adults through targeted exercise interventions.
How similar studies have performed: Other studies have shown promise in using exercise interventions to improve outcomes in frail elderly populations, suggesting that this approach is both relevant and potentially effective.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Age of at least 70 years old. 2. Either gender. 3. Ability to provide informed consent. 4. Ability to perform all the functional tests. 5. In the hospital exercise cohort, ability to perform the physical exercise program. Exclusion Criteria: 1. Expected survival inferior to one year. 2. Barthel scale \< 70. 3. Moderate to severe cognitive impairment. 4. Refuse to participate. 5. Medical conditions that may condition or difficult the follow-up assessments. 6. Older adults already included in regular physical exercise programmes will be excluded to participate in the hospital exercise cohort.
Where this trial is running
Albacete, Castilla La Mancha and 2 other locations
- Complejo Hospitalario Universitario de Albacete — Albacete, Castilla La Mancha, Spain (RECRUITING)
- Donostialdea, Osakidetza — Donostia, Spain (RECRUITING)
- Hospital Universitario de Getafe — Getafe, Spain (RECRUITING)
Study contacts
- Principal investigator: Sergio Sanabria, Ph.D. — University of Deusto
- Study coordinator: Xabier Río de Frutos, Ph.D.
- Email: xabier.rio@deusto.es
- Phone: +34 605754937
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Frailty, Sarcopenia, Ultrasonography, Exercise, Echography, Biomarkers, Diagnostic, Muscle