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Not yet recruiting NCT07388186

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

No phase Interventional Frailty Caregiver Burden Anxiety

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Progressive Muscle Relaxation, Functional Strength Training.
Who it may be relevant to
Registry conditions: Frailty, Caregiver Burden, Anxiety. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Spain
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

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

Overview

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.

Interventions

  • 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.

Primary outcome measures

  • Frailty [Time frame: Baseline, 3-month follow-up and immediately after completion of the intervention (at 10 weeks).]
Secondary outcome measures (2)
  • Anxiety [Time frame: Baseline, 3-month follow-up and immediately after completion of the intervention (at 10 weeks)]
  • Caregiver burden [Time frame: Baseline, 3-month follow-up and immediately after completion of the intervention (at 10 weeks)]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Single blind
Primary purpose
Treatment

Study locations

Spain · 1 center
  • Universidad de Salamanca — Salamanca

Identifiers

NCT: NCT07388186 · STRENGTH_CAREGIVERS_ALZ

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗