Benefits of Strength Training in Informal Caregivers of Patients With Alzheimer's Disease
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity of Salamanca
About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
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
Disqualifiers
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
Design model
Parallel
Treatments tested in this trial
Progressive Muscle Relaxation
BehavioralProgressive 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
BehavioralFunctional 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.
Treatment groups
62 Participants
are divided into 2 treatment groupsGroup A: Progressive Muscle RelaxationActive comparator 1 intervention
Group B: Strength Training plus Progressive Muscle RelaxationExperimental treatment 2 interventions
Trial outcomes
Primary outcomes
1
Frailty
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
Time frame
Baseline, 3-month follow-up and immediately after completion of the intervention (at 10 weeks).Secondary outcomes
1
Anxiety
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.
Time frame
Baseline, 3-month follow-up and immediately after completion of the intervention (at 10 weeks)2
Caregiver burden
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.
Time frame
Baseline, 3-month follow-up and immediately after completion of the intervention (at 10 weeks)Other outcomes
1
Adherence to the intervention
Adherence will be assessed by recording the number of sessions attended and the percentage of completed sessions for each participant.
Time frame
Throughout the 10-week intervention period2
Adverse events
Adverse events or incidents occurring during the intervention sessions, such as musculoskeletal discomfort, dizziness, or other exercise-related events, will be recorded and monitored.
Time frame
Throughout the 10-week intervention periodSponsors and contacts
Click on the lead sponsor to view all of their trials.
University of Salamanca
Lead sponsor
Colegio Profesional de Fisioterapeutas de Castilla y León
Collaborator
CRE Alzheimer del Imserso
Collaborator
Source ClinicalTrials.gov
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