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

University of Salamanca

Status: Begins enrollment this month

Conditions: Caregiver Burden; Frailty; Anxiety

Treatments: Behavioral: Functional Strength Training; Behavioral: Progressive Muscle Relaxation

Study type: Interventional

Funder types: Other

Identifiers

NCT07388186

STRENGTH_CAREGIVERS_ALZ

Details and patient eligibility

About

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.

Full 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.

Enrollment: 62 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Adults aged 18 years or older
• Informal caregivers of a person with Alzheimer's disease
• Providing regular care for at least 10 hours per week
• Ability to attend intervention sessions
• Ability to understand and follow instructions
• Provision of written informed consent

Exclusion criteria

• Acute illness or medical conditions contraindicating participation in strength exercise
• Participation in structured exercise programs that may interfere with study outcomes
• Severe or uncontrolled psychiatric disorders
• Physical limitations preventing completion of functional assessments

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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62 participants in 2 patient groups

Progressive Muscle Relaxation

Active Comparator group

Description:

Participants in this arm will receive one weekly session of progressive muscle relaxation over a 10-week period. Each session will last approximately 45 minutes and will include diaphragmatic breathing, Jacobson's progressive muscle relaxation technique, controlled breathing exercises, and a brief cooldown period. Sessions will be supervised by a trained physiotherapist.

Treatment:

Behavioral: Progressive Muscle Relaxation

Strength Training plus Progressive Muscle Relaxation

Experimental group

Description:

Participants in this arm will receive a combined intervention consisting of one weekly session of progressive muscle relaxation and one weekly session of functional strength training over a 10-week period. Strength training sessions will focus on upper limb, lower limb, and core muscle groups using progressive resistance. Each session will last approximately 45 minutes and will be supervised by a trained physiotherapist.

Treatment:

Behavioral: Progressive Muscle Relaxation

Behavioral: Functional Strength Training