NCT07388186

Benefits of Strength Training in Informal Caregivers of Patients With Alzheimer's Disease

Effectiveness of a Combined Strength Training and Progressive Muscle Relaxation Program in Reducing Frailty in Informal Caregivers of People With Alzheimer's Disease: A Randomized Controlled Trial

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 62 (estimated)
• Sponsor: University of Salamanca · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

Informal caregivers of people with Alzheimer's disease experience high physical and psychological burden, increasing their risk of frailty, anxiety, and caregiver burnout. This randomized controlled trial aims to evaluate the effectiveness of a combined strength training and progressive muscle relaxation program compared with progressive muscle relaxation alone. The intervention will last 10 weeks, with assessments conducted at baseline, post-intervention, and at a 3-month follow-up. Primary outcomes include frailty, anxiety, and caregiver burden.

Detailed description

Alzheimer's disease is associated with long-term caregiving demands that expose informal caregivers to sustained physical and psychological stress. This chronic exposure may contribute to functional decline, increased vulnerability to frailty, and reduced overall well-being, highlighting the need for accessible, non-pharmacological interventions targeting caregiver health. The present study adopts a parallel-group randomized controlled design in which participants are allocated to one of two intervention arms. One group will participate in structured progressive muscle relaxation sessions, while the other will receive a combined intervention integrating functional strength training with progressive muscle relaxation. The intervention protocol has been designed to be feasible, low-cost, and easily implementable in community and clinical settings. Assessments will be conducted at multiple time points to examine changes in physical performance and psychological status over time. Standardized performance-based measures and validated self-report instruments will be used to capture functional and psychosocial outcomes, allowing for a comprehensive evaluation of the intervention effects across short- and medium-term follow-up periods.

Conditions

• Frailty
• Caregiver Burden
• Anxiety

Interventions

Type	Name	Description
BEHAVIORAL	Progressive Muscle Relaxation	Progressive muscle relaxation will be delivered in weekly supervised sessions over a 10-week period. Each session will last approximately 45 minutes and will include diaphragmatic breathing, systematic muscle contraction and relaxation following Jacobson's technique, controlled breathing exercises, and a brief cooldown period. The intervention will be administered by a trained physiotherapist in a group setting.
BEHAVIORAL	Functional Strength Training	Functional strength training will be delivered in weekly supervised sessions over a 10-week period. Sessions will last approximately 45 minutes and will focus on improving upper limb, lower limb, and core muscle strength using progressive resistance exercises. Training intensity will be gradually increased according to participant tolerance and performance. All sessions will be supervised by a trained physiotherapist.

Timeline

• Start date: 2026-03-01
• Primary completion: 2026-07-01
• Completion: 2026-09-01
• First posted: 2026-02-04
• Last updated: 2026-02-04

Locations

1 site across 1 country: Spain