IA Trial Radar | ||
|---|---|---|
O estudo clínico NCT07132632 (FRACTEP-65) para Fragilidade, Sarcopenia, Envelhecimento, Exercises Therapy está ainda não recrutando. Consulte a visualização em cartões do Radar de Estudos Clínicos e as ferramentas de descoberta de IA para ver todos os detalhes. Ou pergunte qualquer coisa aqui. | ||
Um estudo corresponde aos critérios do filtro
Visualização em cartões
Effect of a Multicomponent Therapeutic Exercise Program in Primary Care on Frailty and Sarcopenia in Older Adults (FRACTEP-65) 60 Domiciliar Preventivo Exercício
Os detalhes do estudo clínico estão disponíveis principalmente em inglês. No entanto, a IA Trial Radar pode ajudar! Basta clicar em 'Explicar o estudo' para visualizar e discutir as informações do estudo no idioma selecionado.
O estudo clínico NCT07132632 (FRACTEP-65) é um estudo intervencionista para Fragilidade, Sarcopenia, Envelhecimento, Exercises Therapy. Seu status atual é: ainda não recrutando. O recrutamento está programado para iniciar em 2 de novembro de 2025, com o objetivo de incluir 60 participantes. Coordenado por Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina e deve ser concluído em 31 de dezembro de 2026. Essas informações foram atualizadas no ClinicalTrials.gov em 27 de agosto de 2025.
Resumo
Background:
Frailty and sarcopenia are common conditions in older adults that increase the risk of disability, dependence, and hospitalizations. Frailty is characterized by decreased physiological reserve and functional capacity, while sarcopenia refers to the loss of muscle mass, strength, and performance. Both conditions are prevalent among older adults and represent a growing public health challenge as the popula...
Mostrar maisTítulo oficial
Effect of a Multicomponent Therapeutic Exercise Program in Primary Care on Frailty and Sarcopenia in Older Adults
Condições médicas
FragilidadeSarcopeniaEnvelhecimentoExercises TherapyOutros IDs do estudo
- FRACTEP-65
- IDIAP-FRAIL65
Número NCT
Data de início (real)
2025-11-02
Última atualização postada
2025-08-27
Data de conclusão (estimada)
2026-12-31
Inscrição (estimada)
60
Tipo de estudo
Intervencionista
FASE
N/A
Status
Ainda não recrutando
Propósito principal
Tratamento
Alocação do design
Não randomizado
Modelo de intervenção
Estudo cruzado
Cegamento (Mascaramento)
Cego simples
Braços / Intervenções
| Grupo de participantes/Braço | Intervenção/Tratamento |
|---|---|
ExperimentalArm 1 Multicomponent Exercise Intervention | 12-week multicomponent therapeutic exercise program including supervised and home-based sessions focused on strength, balance, mobility, and aerobic capacity This intervention consists of a 12-week multicomponent therapeutic exercise program for older adults with mild to moderate frailty. Participants will complete 12 sessions (8 supervised in primary care and 4 home-based), each lasting approximately 60 minutes. Sessions include warm-up, strength exercises (using body weight or elastic bands), moderate aerobic activity (e.g., walking or pedaling), balance and coordinatio...Mostrar mais |
Comparador placeboControl Arm | Placebo Pre-Treat The pre-intervention period (Month 0 to Month 3) will serve as the control phase, during which participants will receive no specific exercise program. From Month 3 to Month 6, the intervention phase will begin. Participants act as their own control. |
Desfecho primário
Desfecho secundário
| Medida de desfecho | Descrição da medida | Prazo |
|---|---|---|
Change from Baseline in Clinical Frailty Scale (CFS) Score at 6 Months | Clinical Frailty Scale (CFS) is a 9-point ordinal scale assessing functional and clinical status in older adults. A change of ≥0.5 points is considered clinically significant. | Baseline (Month 0) to Month 6 |
| Medida de desfecho | Descrição da medida | Prazo |
|---|---|---|
Baseline (Month 0) to Month 6 | Handgrip strength measured using a Jamar® dynamometer. The average of three trials per hand will be used. A decrease indicates lower muscle strength, a key sarcopenia marker. | Baseline (Month 0) to Month 6 |
Change from Baseline in Short Physical Performance Battery (SPPB) Score at 6 Months | Composite score from balance tests, 4-meter gait speed, and chair rise test. Score ranges from 0 to 12, with ≤8 indicating poor physical performance. | Baseline (Month 0) to Month 6 |
Change from Baseline in Gait Speed (4-Meter Walk Test) at 6 Months | Average walking speed over 4 meters. Lower speeds (\<0.8 m/s) are associated with higher frailty and fall risk. | Baseline (Month 0) to Month 6 |
Change from Baseline in Timed Up and Go (TUG) Test Performance at 6 Months | Time to rise from a chair, walk 3 meters, turn, return, and sit. Times ≥13.5 seconds indicate increased fall risk. | Baseline (Month 0) to Month 6 |
Change from Baseline in Estimated Skeletal Muscle Mass Index at 6 Months | Calculated using anthropometric data via Lee et al.'s validated formula. | Baseline (Month 0) to Month 6 |
Change in Rectus Femoris and Vastus Lateralis Muscle Thickness at 6 Months | Ultrasound-based assessment of muscle thickness and adipose tissue content in the dominant lower limb. | Baseline (Month 0) to Month 6 |
Change from Baseline in Mini Nutritional Assessment-Short Form (MNA-SF) Score at 6 Months | Nutrition screening tool (score 0-14). Categories: well-nourished (\>11), at risk (8-11), malnourished (\<8). | Baseline (Month 0) to Month 6 |
Change from Baseline in Mini-Mental State Examination (MMSE) Score at 6 Months | Cognitive status measured with MMSE (score 0-30). Scores \<26 suggest cognitive impairment. | Baseline (Month 0) to Month 6 |
Number of Participants with Hospital Admissions During the Study Period | Self-reported or caregiver-reported data on hospitalizations. | Baseline (Month 0) to Month 6 |
Number of Participants Reporting Falls During the Study Period | Number of self-reported falls tracked throughout the study. | Baseline (Month 0) to Month 6 |
Adherence to Home-Based Exercise Sessions (Self-Reported Completion Rate) | Percentage of home-based sessions completed, based on self-records and phone follow-up. | Over the 12-week intervention |
Self-Reported Enjoyment of Physical Activity (Likert Scale) at 6 Months | Degree of enjoyment assessed on a Likert scale from 1 (not enjoyable) to 5 (very enjoyable). | At Month 6 |
Assistente de participação
Critérios de elegibilidade
Idades elegíveis
Idoso
Idade mínima
65 Years
Sexos elegíveis
Todos
- Adults aged 65 years or older, receiving care from primary care physiotherapists at participating health centers.
- Clinical Frailty Scale (CFS) score between 4 and 6 (indicating vulnerable, mild, or moderate frailty).
- Ability to walk independently, with or without assistive devices (excluding habitual wheelchair use).
- Clinically stable, defined as the absence of acute events or clinical decompensation in the previous 4 weeks.
- Sufficient cognitive ability to understand and follow basic instructions, or the availability of an actively involved caregiver (MMSE ≥ 20 or equivalent).
- Signed informed consent from the participant or their legal representative.
- Diagnosis of severe frailty or advanced dependence (CFS ≥ 7).
- Severe neurological or musculoskeletal disorders that limit safe exercise participation (e.g., Parkinson's disease, stroke with major sequelae, disabling arthropathies).
- Uncontrolled cardiac, respiratory, or other medical conditions that contraindicate physical activity.
- Moderate to severe cognitive impairment, defined by MMSE < 20 or a clinical diagnosis of dementia with significant functional limitations.
- Simultaneous participation in other structured physical intervention programs.
Fundacio d'Investigacio en Atencio Primaria Jordi Gol i GurinaResponsável pelo estudo
Yaiza Casas, Investigador principal, Principal Investigator and Physiotherapist, Primary Care - Institut Català de la Salut (ICS), Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina
Sem dados de contato.