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
- Phase
- Not Applicable
- Status
- Not yet recruiting
- Sponsor
- University of Salamanca
- Enrollment
- 62
- Locations
- 1
- Primary Endpoint
- Frailty
Overview
Brief 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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
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
Arms & Interventions
Progressive Muscle Relaxation
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.
Intervention: Progressive Muscle Relaxation (Behavioral)
Strength Training plus Progressive Muscle Relaxation
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.
Intervention: Progressive Muscle Relaxation (Behavioral)
Strength Training plus Progressive Muscle Relaxation
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.
Intervention: Functional Strength Training (Behavioral)
Outcomes
Primary Outcomes
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
- Anxiety(Baseline, 3-month follow-up and immediately after completion of the intervention (at 10 weeks))
- Caregiver burden(Baseline, 3-month follow-up and immediately after completion of the intervention (at 10 weeks))
Investigators
Andrea Calleja Caballero
Physical therapist
University of Salamanca