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NCT Number: NCT07388186

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

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.

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Key information

Conditions

Frailty Alzheimer Disease Anxiety Anxiety Disorders Behavior Behavioral Symptoms Brain Diseases Caregiver Burden Central Nervous System Diseases Dementia Mental Disorders Nervous System Diseases Neurocognitive Disorders Neurodegenerative Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Stress, Psychological Tauopathies

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Progressive Muscle Relaxation

Behavioral

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.

Functional Strength Training

Behavioral

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 outcomes

  1. Frailty

    Time frame: Baseline, 3-month follow-up and immediately after completion of the intervention (at 10 weeks).

    Frailty will be assessed using the Short Physical Performance Battery (SPPB) and handgrip strength measured with a hand dynamometer.

    The SPPB includes balance, gait speed, and lower-limb strength components. The score is obtained by summing the results of three performance-based tests: balance, gait speed over 4 meters, and the five-times sit-to-stand chair test. The total score ranges from 0 to 12 points, where 0 represents the worst performance and 12 the best performance. Lower scores (generally <10) indicate frailty and increased risk of falls. Performance is classified as follows: 0-3 (disabled), 4-6 (frail), 7-9 (prefrail), and 10-12 (independent).

    Handgrip strength will be measured using a hand dynamometer, and the absolute grip strength value will be recorded. The Fried frailty phenotype includes handgrip strength (dynamometry) as one of the five key criteria for identifying frailty in older adults. Cut-off values indicative of muscle weakness, adjusted for sex and body mass

Secondary outcomes

  1. Anxiety

    Time frame: Baseline, 3-month follow-up and immediately after completion of the intervention (at 10 weeks)

    Anxiety symptoms will be assessed using the Hamilton Anxiety Rating Scale (HAM-A), a validated clinician-rated questionnaire evaluating psychological and somatic anxiety symptoms. HAM-A is scored on a scale of 0 (not present) to 4 (severe), with a total score range of 0-56, where <17 indicates mild severity, 18-24 mild to moderate severity and 25-30 moderate to severe.

  2. Caregiver burden

    Time frame: Baseline, 3-month follow-up and immediately after completion of the intervention (at 10 weeks)

    Caregiver burden will be assessed using the Zarit Burden Interview (ZBI), a validated self-report questionnaire measuring perceived burden in informal caregivers. The total score is calculated as the sum of all items, with a possible range from 22 to 110. Each item is rated using a 5-point Likert-type scale, with response options ranging from "never" to "almost always", scored from 1 to 5.

Other outcomes

  1. Adherence to the intervention

    Time frame: Throughout the 10-week intervention period

    Adherence will be assessed by recording the number of sessions attended and the percentage of completed sessions for each participant.

  2. Adverse events

    Time frame: Throughout the 10-week intervention period

    Adverse events or incidents occurring during the intervention sessions, such as musculoskeletal discomfort, dizziness, or other exercise-related events, will be recorded and monitored.

Study contacts

Contact information is provided by the study sponsor or research team.

Andrea Calleja Caballero, Principal Investigator

CONTACT

[email protected]

+34 616957689

Sponsors and collaborators

Lead sponsor

University of Salamanca

Other

Collaborators

  • CRE Alzheimer del Imserso
  • Colegio Profesional de Fisioterapeutas de Castilla y León

Registry information

Official study 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

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Feb 4, 2026
Registry last updated
Feb 4, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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