FrailtyNCT07388186
Benefits of Strength Training in Informal Caregivers of Patients With Alzheimer's Disease
A study testing Progressive Muscle Relaxation and Functional Strength Training in people with Frailty and Caregiver Burden, run by University of Salamanca at 1 site in Spain.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Frailty, Caregiver Burden, Anxiety
- What is being tested?
- Progressive Muscle Relaxation and Functional Strength Training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 43 participants
- Where
- 1 siteSpain
- Study dates
- 10 Apr 2026to 10 Oct 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
1 site in 1 country.
About this study
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
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.
Read the 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.
- Conditions
- Frailty, Caregiver Burden, Anxiety
- Being tested
- Progressive Muscle Relaxation, Functional Strength Training
- Keywords
- Frailty, Strength, Caregiver, Anxiety, Burden, Alzheimer disease
- Medical subject headings
- Frailty, Caregiver Burden, Anxiety Disorders, Alzheimer Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Progressive Muscle RelaxationBehavioural
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 TrainingBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Progressive Muscle Relaxation | Active comparator | 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. Receives: Behavioral: Progressive Muscle Relaxation |
| Strength Training plus Progressive Muscle Relaxation | Experimental | 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. Receives: Behavioral: Progressive Muscle Relaxation; Behavioral: Functional Strength Training |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Baseline, 3-month follow-up and immediately after completion of the intervention (at 10 weeks).
Secondary outcomes (2)
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.
Measured: Baseline, 3-month follow-up and immediately after completion of the intervention (at 10 weeks)
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.
Measured: Baseline, 3-month follow-up and immediately after completion of the intervention (at 10 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Feb 2026
- Study start10 Apr 2026
- Primary completion28 Sep 2026
- Study completion10 Oct 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for FrailtyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants will be randomly assigned to one of two parallel intervention arms and will receive either progressive muscle relaxation alone or a combined program of functional strength training and progressive muscle relaxation over a 10-week period.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 43 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Salamanca
- Sponsor type
- University, hospital or other
- Collaborators
- Colegio Profesional de Fisioterapeutas de Castilla y León, CRE Alzheimer del Imserso
- Responsible party
- Principal investigator, Andrea Calleja Caballero, University of Salamanca
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07388186
- Sponsor's protocol ID
- STRENGTH_CAREGIVERS_ALZ
- Status last verified
- Oct 2026
- First submitted
- 22 Jan 2026
- Last updated
- 16 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: De-identified individual participant data will not be shared outside the study team due to ethical, privacy, and data protection considerations.
Publications
Sanchez-Gil A, Sanchez-Gonzalez JL, Gomez-Mateos M, Santos-Rodriguez V, Garcia-Santelesforo R, Perez J, Perez-Robledo F, Perez-Saez E, Calleja-Caballero A. Combined functional strength training and progressive muscle relaxation in informal caregivers of people with dementia: protocol for a randomized controlled trial. Front Psychol. 2026 Sep 17;17:1944170. doi: 10.3389/fpsyg.2026.1944170. eCollection 2026.
PubMed 42824482
Study at a glance
From the registry record, last updated by the sponsor on 16 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT07388186
- Acronym / sponsor ID
- STRENGTH_CAREGIVERS_ALZ
- Conditions
- Frailty, Caregiver Burden, Anxiety
- Keywords
- Frailty, Strength, Caregiver, Anxiety, Burden, Alzheimer disease
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 43 participants (actual)
- Lead sponsor
- University of SalamancaUniversity, hospital or other
- Collaborators
- Colegio Profesional de Fisioterapeutas de Castilla y León, CRE Alzheimer del Imserso
- Study start
- 10 Apr 2026 (actual)
- Primary completion
- 28 Sep 2026 (actual)
- Study completion
- 10 Oct 2026 (actual)
- First posted
- 4 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Participants will be randomly assigned to one of two parallel intervention arms and will receive either progressive muscle relaxation alone or a combined program of functional strength training and progressive muscle relaxation over a 10-week period.
| Arm | Type | Receives |
|---|---|---|
| Progressive Muscle Relaxation | Active comparator | Behavioral: Progressive Muscle RelaxationParticipants 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. |
| Strength Training plus Progressive Muscle Relaxation | Experimental | Behavioral: Progressive Muscle Relaxation, Behavioral: Functional Strength TrainingParticipants 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Progressive Muscle RelaxationProgressive 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. | Behavioural | Progressive Muscle Relaxation, Strength Training plus Progressive Muscle Relaxation |
| Functional Strength TrainingFunctional 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. | Behavioural | Strength Training plus Progressive Muscle Relaxation |
Primary outcome
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
2 secondary outcomes
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)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Oct 2026.
- Derived from this study: PubMed 42824482Sanchez-Gil A, Sanchez-Gonzalez JL, Gomez-Mateos M, Santos-Rodriguez V, Garcia-Santelesforo R, Perez J, Perez-Robledo F, Perez-Saez E, Calleja-Caballero A. Combined functional strength training and progressive muscle relaxation in informal caregivers of people with dementia: protocol for a randomized controlled trial. Front Psychol. 2026 Sep 17;17:1944170. doi: 10.3389/fpsyg.2026.1944170. eCollection 2026.
- Individual participant dataSharing planned: No. De-identified individual participant data will not be shared outside the study team due to ethical, privacy, and data protection considerations.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Progressive Muscle Relaxation and Functional Strength Training in people with Frailty and Caregiver Burden, run by University of Salamanca at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Frailty (time frame: Baseline, 3-month follow-up and immediately after completion of the intervention (at 10 weeks).). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07388186, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Oct 2026.