Frontiers in psychology · 2026
Combined functional strength training and progressive muscle relaxation in informal caregivers of people with dementia: protocol for a randomized controlled trial.
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Sánchez-Gil Alba, Sánchez-González Juan Luis, Gómez-Mateos Marta, Santos-Rodríguez Vanesa, García-Santelesforo Raquel, Pérez Jesús, Pérez-Robledo Fátima, Pérez-Sáez Enrique, Calleja-Caballero Andrea
Аннотация
BACKGROUND: Informal caregivers of people living with dementia are exposed to sustained physical and psychological demands that may increase their risk of functional decline, anxiety, and caregiver burden. While exercise and relaxation interventions have shown independent benefits, evidence on structured multicomponent programs integrating both physical and psychological approaches remains limited. This study protocol describes a randomized controlled trial designed to evaluate the effectiveness of a combined functional strength training and progressive muscle relaxation program in informal caregivers.
METHODS: A prospective, parallel-group randomized controlled trial will be conducted in informal caregivers of people with dementia. Sixty-two informal caregivers will be randomly allocated (1:1) to either a combined intervention group (functional strength training plus progressive muscle relaxation) or a comparison group receiving progressive muscle relaxation alone. The intervention will last 10 weeks. The combined intervention group will attend two weekly sessions (one strength training and one relaxation session), whereas the comparison group will attend one weekly relaxation session. Lower-extremity physical performance, assessed using the total Short Physical Performance Battery (SPPB) score at 10 weeks, will be the primary outcome. Secondary outcomes will include handgrip strength, anxiety, caregiver burden, adherence, and safety. Outcomes will also be assessed at the 3-month follow-up. Analyses will follow the intention-to-treat principle.
DISCUSSION: This trial will provide evidence on the effectiveness, feasibility, and safety of a structured multicomponent intervention targeting both physical function and psychological burden in informal caregivers. The findings may contribute to the development of comprehensive and replicable caregiver support programs in real-world health and social care settings.
CLINICAL TRIAL REGISTRATION: ClinicalTrials.gov, Identifier: NCT07388186.
METHODS: A prospective, parallel-group randomized controlled trial will be conducted in informal caregivers of people with dementia. Sixty-two informal caregivers will be randomly allocated (1:1) to either a combined intervention group (functional strength training plus progressive muscle relaxation) or a comparison group receiving progressive muscle relaxation alone. The intervention will last 10 weeks. The combined intervention group will attend two weekly sessions (one strength training and one relaxation session), whereas the comparison group will attend one weekly relaxation session. Lower-extremity physical performance, assessed using the total Short Physical Performance Battery (SPPB) score at 10 weeks, will be the primary outcome. Secondary outcomes will include handgrip strength, anxiety, caregiver burden, adherence, and safety. Outcomes will also be assessed at the 3-month follow-up. Analyses will follow the intention-to-treat principle.
DISCUSSION: This trial will provide evidence on the effectiveness, feasibility, and safety of a structured multicomponent intervention targeting both physical function and psychological burden in informal caregivers. The findings may contribute to the development of comprehensive and replicable caregiver support programs in real-world health and social care settings.
CLINICAL TRIAL REGISTRATION: ClinicalTrials.gov, Identifier: NCT07388186.