Alzheimer DiseaseNCT05862935
Influence of Physical Exercise as Adjuvant Treatment in Patients With Alzheimer's Disease
A study testing Supervised Physical Activity (AMRAP -As Many Repetitions As Possible): Phase 2 and Supervised Physical Activity: Phase 1 in people with Alzheimer Disease, run by European University Miguel de Cervantes at 1 site in Spain.
Trial summary
The goal of this non-randomized clinical trial is to assess the effects of strength training in the physical function of Alzheimer's disease (AD) patients. The main question it aims to answer are: 1. Is a basic strength training enough to improve physical function in AD patients? 2. Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- Alzheimer Disease
- What is being tested?
- Supervised Physical Activity (AMRAP -As Many Repetitions As Possible): Phase 2 and Supervised Physical Activity: Phase 1
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 26 participants
- Where
- 1 siteSpain
- Study dates
- 1 Jun 2022to 1 Feb 2023
- 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 60 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- MMSE (Mini-Metal State Examination) score of ≥15 out of 35 (at screening less than 2 months prior to baseline visit)
- Age ≥60 years old
- Be able to walk with or without aids
- Be able to follow verbal instructions
Who cannot join
- Surgery in the last 3 months
- Exhibit clear signs of disorientation
- Clinically confirmed signs of aggressiveness
Trial locations and contacts
1 site in 1 country.
About this study
The goal of this non-randomized clinical trial is to assess the effects of strength training in the physical function of Alzheimer's disease (AD) patients. The main question it aims to answer are:
- Is a basic strength training enough to improve physical function in AD patients?
- Is an exercise intervention able to delayed the progression of the disease?
- Is an AMRAP intervention feasible in AD patients?
Participants in the exercise group will perform a 16-weeks program divided in two phases (phase 1: basic strength training; phase 2: AMRAP training). Participants in both (exercise and control) groups will receive their usual care treatments which include occupational therapy, musicotherapy, cognitive stimulation and sensory stimulation.
- Conditions
- Alzheimer Disease
- Being tested
- Supervised Physical Activity (AMRAP -As Many Repetitions As Possible): Phase 2, Supervised Physical Activity: Phase 1
- Keywords
- Dementia, Physical exercise, Locomotion
- Medical subject headings
- Alzheimer Disease, Dementia, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Supervised Physical Activity (AMRAP -As Many Repetitions As Possible): Phase 2Other
Also called AMRAP intervention
20-30 min/session, 3 times/week for 4 weeks. After a 5-min warm-up, participants perform a moderate-intensity functional training program. This program is designed in circuit mode consisting of 6 global functional exercises: i) sit and stand, ii) forward lunges, iii) chest press, iv) high row, v) lateral shoulder raises and vi) heel raises. Participants must complete the highest number of repetitions and/or rounds as possible (AMRAP) in 15-min without a designated rest.
Supervised Physical Activity: Phase 1Other
Also called Basic strength intervention
40-60 min/session, 3 times/week for 12 weeks. After a 5-min warm-up, participants performed 6 global functional exercises: i) sit-to-stand; ii) chest press, iii) forward lunges; iv) unilateral shoulder raises; v) unilateral row; and vi) heel raises. The initial volume is 2 sets and 8 repetitions and it will progressively increase until 3 sets and 12 repetitions.
| Study group | Role | What they receive |
|---|---|---|
| Supervised Physical Activity (Phase I: Strength training; Phase II: AMRAP training) | Experimental | These patients, in addition to receiving the usual treatment for their pathology, carry out supervised activity consisting of:
* Warm-up
* Strength circuit; At phase I it will be a standard strength training, while at Phase 2 it will be an AMRAP training) Receives: Other: Supervised Physical Activity (AMRAP -As Many Repetitions As Possible): Phase 2; Other: Supervised Physical Activity: Phase 1 |
| Control | No intervention | These patients only receive the usual treatment for their pathology. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Short Physical Performance Battery
Changes in the SPPB Score (Short Physical Performance Battery; Range between 0 "worst performance" and 12 "best performance")
Measured: 0 weeks, 12 weeks, 16 weeks of intervention. 8 weeks of detraining
Secondary outcomes (3)
Handgrip strength
Changes in the hang-up strength in the dominant side
Measured: 0 weeks, 12 weeks, 16 weeks of intervention. 8 weeks of detraining
Body mass index
Changes in the body mass index
Measured: 0 weeks, 12 weeks, 16 weeks of intervention. 8 weeks of detraining
Practicability of AMRAP (As Many Repetitions As Possible) training; it will be analysed by calculating both intra- and inter-subject coefficient variation.
This variable evaluates the applicability of this tipe of training in patients with Alzheimer disease
Measured: Every session (during 13 sessions)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 May 2023
- Study start1 Jun 2022
- Primary completion15 Jan 2023
- Study completion1 Feb 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Alzheimer DiseaseStudies 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
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- Non-randomized controlled trial
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 26 participants (actual)
Sponsor and investigators
- Lead sponsor
- European University Miguel de Cervantes
- Sponsor type
- University, hospital or other
- Collaborators
- Asociación de Familiares de Alzheimer de Valladolid
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05862935
- Sponsor's protocol ID
- PI-DOC002-ALP
- Status last verified
- Jan 2024
- First submitted
- 3 May 2023
- Last updated
- 11 Jan 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Influence of Physical Exercise as Adjuvant Treatment in Patients With Alzheimer's Disease
- ClinicalTrials.gov ID
- NCT05862935
- Acronym / sponsor ID
- PI-DOC002-ALP
- Conditions
- Alzheimer Disease
- Keywords
- Dementia, Physical exercise, Locomotion
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 26 participants (actual)
- Lead sponsor
- European University Miguel de CervantesUniversity, hospital or other
- Collaborators
- Asociación de Familiares de Alzheimer de Valladolid
- Study start
- 1 Jun 2022 (actual)
- Primary completion
- 15 Jan 2023 (actual)
- Study completion
- 1 Feb 2023 (actual)
- First posted
- 17 May 2023 (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.
The goal of this non-randomized clinical trial is to assess the effects of strength training in the physical function of Alzheimer's disease (AD) patients. The main question it aims to answer are:
- Is a basic strength training enough to improve physical function in AD patients?
- Is an exercise intervention able to delayed the progression of the disease?
- Is an AMRAP intervention feasible in AD patients?
Participants in the exercise group will perform a 16-weeks program divided in two phases (phase 1: basic strength training; phase 2: AMRAP training). Participants in both (exercise and control) groups will receive their usual care treatments which include occupational therapy, musicotherapy, cognitive stimulation and sensory stimulation.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Non-randomized controlled trial
| Arm | Type | Receives |
|---|---|---|
| Supervised Physical Activity (Phase I: Strength training; Phase II: AMRAP training) | Experimental | Other: Supervised Physical Activity (AMRAP -As Many Repetitions As Possible): Phase 2, Other: Supervised Physical Activity: Phase 1These patients, in addition to receiving the usual treatment for their pathology, carry out supervised activity consisting of: * Warm-up * Strength circuit; At phase I it will be a standard strength training, while at Phase 2 it will be an AMRAP training) |
| Control | No intervention | –These patients only receive the usual treatment for their pathology. |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- MMSE (Mini-Metal State Examination) score of ≥15 out of 35 (at screening less than 2 months prior to baseline visit)
- Age ≥60 years old
- Be able to walk with or without aids
- Be able to follow verbal instructions
Key exclusion criteria (3 listed)
- Surgery in the last 3 months
- Exhibit clear signs of disorientation
- Clinically confirmed signs of aggressiveness
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 |
|---|---|---|
| Supervised Physical Activity (AMRAP -As Many Repetitions As Possible): Phase 2Also: AMRAP intervention20-30 min/session, 3 times/week for 4 weeks. After a 5-min warm-up, participants perform a moderate-intensity functional training program. This program is designed in circuit mode consisting of 6 global functional exercises: i) sit and stand, ii) forward lunges, iii) chest press, iv) high row, v) lateral shoulder raises and vi) heel raises. Participants must complete the highest number of repetitions and/or rounds as possible (AMRAP) in 15-min without a designated rest. | Other | Supervised Physical Activity (Phase I: Strength training; Phase II: AMRAP training) |
| Supervised Physical Activity: Phase 1Also: Basic strength intervention40-60 min/session, 3 times/week for 12 weeks. After a 5-min warm-up, participants performed 6 global functional exercises: i) sit-to-stand; ii) chest press, iii) forward lunges; iv) unilateral shoulder raises; v) unilateral row; and vi) heel raises. The initial volume is 2 sets and 8 repetitions and it will progressively increase until 3 sets and 12 repetitions. | Other | Supervised Physical Activity (Phase I: Strength training; Phase II: AMRAP training) |
Primary outcome
Short Physical Performance Battery
Time frame: 0 weeks, 12 weeks, 16 weeks of intervention. 8 weeks of detraining
Changes in the SPPB Score (Short Physical Performance Battery; Range between 0 "worst performance" and 12 "best performance")
3 secondary outcomes
Handgrip strength
Time frame: 0 weeks, 12 weeks, 16 weeks of intervention. 8 weeks of detraining
Body mass index
Time frame: 0 weeks, 12 weeks, 16 weeks of intervention. 8 weeks of detraining
Practicability of AMRAP (As Many Repetitions As Possible) training; it will be analysed by calculating both intra- and inter-subject coefficient variation.
Time frame: Every session (during 13 sessions)
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 11 Jan 2024.
- Individual participant dataSharing planned: No
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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 Supervised Physical Activity (AMRAP -As Many Repetitions As Possible): Phase 2 and Supervised Physical Activity: Phase 1 in people with Alzheimer Disease, run by European University Miguel de Cervantes 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 4 inclusion and 3 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 11 Jan 2024. 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?
Short Physical Performance Battery (time frame: 0 weeks, 12 weeks, 16 weeks of intervention. 8 weeks of detraining). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 11 Jan 2024.