Alzheimer Disease, Early OnsetHOPENCT04916964
Adapted Home-based Exercise Program "T&E" (Test-and-Exercise) in Persons With Alzheimer's Disease (HOPE Trial)
A study testing Test and exercise home-based program in people with Alzheimer Disease, Early Onset, run by HES-SO Valais-Wallis at 1 site in Switzerland.
Trial summary
The aim of this exploratory pilot study is to assess the feasibility and effectiveness of the adapted T\&E home-based exercise program on the basic functional mobility and executive functions in persons with mild or probable Alzheimer's Disease. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Alzheimer Disease, Early Onset
- What is being tested?
- Test and exercise home-based program
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteSwitzerland
- Study dates
- 30 Jun 2021to 30 Dec 2021
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Must living at their own home,
- Clinical diagnosis of mild or probable Alzheimer's Disease,
- Must be medical stable,
- Must be able to walk with or without assistive device without physical assistance of another person,
- Must be able to follow one-step commands,
- Family caregiver's must agree to participate at the training sessions.
Who cannot join
- Severe vision and verbal impairment,
- Any serious orthopaedic condition,
- Any major neurologic or musculoskeletal comorbidity that might affect their functional mobility,
- Any limiting cardiac or pulmonary condition.
Trial locations and contacts
1 site in 1 country.
Switzerland1 site, 1 recruiting
- Recruiting
CMS Sierre Région
Sierre, Valais, 3960
Laurence Adler, MSc, 791371027 ext. 0041, laurence.adler@cms-smz.ch
About this study
Official title: Effects of the Adapted Home-based Exercise Program "T&E" (Test-and-Exercise) on Balance, Mobility, and Executive Functions in Persons With Alzheimer's Disease: Protocol for an Exploratory Pilot Study
The aim of this exploratory pilot study is to assess the feasibility and effectiveness of the adapted T\&E home-based exercise program on the basic functional mobility and executive functions in persons with mild or probable Alzheimer's Disease.
Read the detailed description
Primary and secondary outcomes will be measured at T0 (one week before the begin of the intervention) and T1, (one week after the eight weeks of the intervention) at home of the participants.
Eight home-based physiotherapy sessions will occur in two months, once a week, to activate the preserved implicit memory (PIM). The recommendations are to train three weeks with the same exercise program, three times a week (one time coached by the attributed physiotherapist and two times coached by a natural or family caregiver). After three weeks, the participants can choose if they want to keep the same exercises or change all or some of these, in testing other tasks. Every training session will be planned to last 45 minutes. During each training session, the participant will note on his/her own "Training booklet" each task performed. The "Training booklet" will be used to plane, organize, and remember details for the next training session.
Twelve participants will take part at this study.
- Conditions
- Alzheimer Disease, Early Onset
- Being tested
- Test and exercise home-based program
- Keywords
- Home-based exercise program, Basic functional mobility, Central executive functions
- Medical subject headings
- Alzheimer Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Test and exercise home-based programOther
Also called T&E
Eight home-based physiotherapy sessions will occur in two months, once a week, to activate the preserved implicit memory (PIM). The recommendations are to train three weeks with the same exercise program, three times a week (one time coached by the attributed physiotherapist and two times coached by a natural or family caregiver). After three weeks, the participants can choose if they want to keep the same exercises or change all or some of these, in testing other tasks. Every training session will be planned to last 45 minutes. During each training session, the participant will note on his/her own "Training booklet" each task performed. The "Training booklet" will be used to plane, organize, and remember details for the next training session.
| Study group | Role | What they receive |
|---|---|---|
| Test & Exercise home-based program (T&E) | Experimental | Eight home-based physiotherapy sessions will occur in two months, once a week Receives: Other: Test and exercise home-based program |
What is being measured
The primary outcome is the main question the study is designed to answer.
Functional mobility
Berg Balance Scale (BBS), scoring ranges from 0 (worse) to 56 (best)
Measured: 8 weeks
Stand and go
Time Up and Go test (TUG) in seconds
Measured: 8 weeks
Sit to stand
Five Time Sit to Stand (FTSTS) in seconds
Measured: 8 weeks
Walking speed
The self-selected and the maximal walking speed (SSWS/MWS) on a 6-meter walk
Measured: 8 weeks
Secondary outcomes (7)
The Set shifting (Mental flexibility)
Trail Making Test Part-Be in seconds
Measured: 8 weeks
The updating (Working memory)
Digit span backward task, number of the successful sequences between 0 and 14
Measured: 8 weeks
The response inhibition
Stroop Color and Word Test (SCWT) Victoria, comparison of the expected score to the participant's score to calculate the Z-score
Measured: 8 weeks
Feasibility of recruitement
Inclusion of 12 subjects between the 30 of May 2021 ant the 30 of Septembre 2021
Measured: 4 months
Participation agreement
Fulfilled if 75% of eligible subjects agree to participate and sign the consent
Measured: 4 months
Costs
Fulfilled if the cost does not exceed the planed amounts by more than 5%
Measured: 8 months
Drop out / withdraw
Fulfilled if 75% of the participants take part in the total duration of the study
Measured: 8 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jun 2021
- Study start30 Jun 2021 (estimated)
- Primary completion30 Oct 2021 (estimated)
- Study completion30 Dec 2021 (estimated)
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 Alzheimer Disease, Early OnsetStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 12 participants (estimated)
Sponsor and investigators
- Lead sponsor
- HES-SO Valais-Wallis
- Sponsor type
- University, hospital or other
- Collaborators
- Hilfiker Roger
- Responsible party
- Principal investigator, Mittaz Hager Anne-Gabrielle, HES-SO Valais-Wallis
- Investigators
- Anne-Gabrielle Mittaz Hager, PhD Cand, Principal investigator, HES-SO Valais-Wallis
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04916964
- Sponsor's protocol ID
- HOPE
- Acronym
- HOPE
- Status last verified
- Jun 2021
- First submitted
- 31 May 2021
- Last updated
- 8 Jun 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Carrard S, Eyer S, Hilfiker R, Mittaz Hager AG. Adapted Home-Based Exercises in Dementia: An Exploratory Pre-post Pilot and Feasibility Study. Am J Alzheimers Dis Other Demen. 2024 Jan-Dec;39:15333175241263741. doi: 10.1177/15333175241263741.
PubMed 38877608
Study at a glance
From the registry record, last updated by the sponsor on 8 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of the Adapted Home-based Exercise Program "T&E" (Test-and-Exercise) on Balance, Mobility, and Executive Functions in Persons With Alzheimer's Disease: Protocol for an Exploratory Pilot Study
- ClinicalTrials.gov ID
- NCT04916964
- Acronym / sponsor ID
- HOPE / HOPE
- Conditions
- Alzheimer Disease, Early Onset
- Keywords
- Home-based exercise program, Basic functional mobility, Central executive functions
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 12 participants (estimated)
- Lead sponsor
- HES-SO Valais-WallisUniversity, hospital or other
- Collaborators
- Hilfiker Roger
- Study start
- 30 Jun 2021 (estimated)
- Primary completion
- 30 Oct 2021 (estimated)
- Study completion
- 30 Dec 2021 (estimated)
- First posted
- 8 Jun 2021 (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 aim of this exploratory pilot study is to assess the feasibility and effectiveness of the adapted T\&E home-based exercise program on the basic functional mobility and executive functions in persons with mild or probable Alzheimer's Disease.
Detailed description
Primary and secondary outcomes will be measured at T0 (one week before the begin of the intervention) and T1, (one week after the eight weeks of the intervention) at home of the participants.
Eight home-based physiotherapy sessions will occur in two months, once a week, to activate the preserved implicit memory (PIM). The recommendations are to train three weeks with the same exercise program, three times a week (one time coached by the attributed physiotherapist and two times coached by a natural or family caregiver). After three weeks, the participants can choose if they want to keep the same exercises or change all or some of these, in testing other tasks. Every training session will be planned to last 45 minutes. During each training session, the participant will note on his/her own "Training booklet" each task performed. The "Training booklet" will be used to plane, organize, and remember details for the next training session.
Twelve participants will take part at this study.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Test & Exercise home-based program (T&E) | Experimental | Other: Test and exercise home-based programEight home-based physiotherapy sessions will occur in two months, once a week |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (6 listed)
- Must living at their own home,
- Clinical diagnosis of mild or probable Alzheimer's Disease,
- Must be medical stable,
- Must be able to walk with or without assistive device without physical assistance of another person,
- Must be able to follow one-step commands,
Key exclusion criteria (4 listed)
- Severe vision and verbal impairment,
- Any serious orthopaedic condition,
- Any major neurologic or musculoskeletal comorbidity that might affect their functional mobility,
- Any limiting cardiac or pulmonary condition.
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 |
|---|---|---|
| Test and exercise home-based programAlso: T&EEight home-based physiotherapy sessions will occur in two months, once a week, to activate the preserved implicit memory (PIM). The recommendations are to train three weeks with the same exercise program, three times a week (one time coached by the attributed physiotherapist and two times coached by a natural or family caregiver). After three weeks, the participants can choose if they want to keep the same exercises or change all or some of these, in testing other tasks. Every training session will be planned to last 45 minutes. During each training session, the participant will note on his/her own "Training booklet" each task performed. The "Training booklet" will be used to plane, organize, and remember details for the next training session. | Other | Test & Exercise home-based program (T&E) |
Primary outcome
Functional mobility
Time frame: 8 weeks
Berg Balance Scale (BBS), scoring ranges from 0 (worse) to 56 (best)
Stand and go
Time frame: 8 weeks
Time Up and Go test (TUG) in seconds
Sit to stand
Time frame: 8 weeks
Five Time Sit to Stand (FTSTS) in seconds
Walking speed
Time frame: 8 weeks
The self-selected and the maximal walking speed (SSWS/MWS) on a 6-meter walk
7 secondary outcomes
The Set shifting (Mental flexibility)
Time frame: 8 weeks
The updating (Working memory)
Time frame: 8 weeks
The response inhibition
Time frame: 8 weeks
Feasibility of recruitement
Time frame: 4 months
Participation agreement
Time frame: 4 months
Costs
Time frame: 8 months
Drop out / withdraw
Time frame: 8 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jun 2021.
- Derived from this study: PubMed 38877608Carrard S, Eyer S, Hilfiker R, Mittaz Hager AG. Adapted Home-Based Exercises in Dementia: An Exploratory Pre-post Pilot and Feasibility Study. Am J Alzheimers Dis Other Demen. 2024 Jan-Dec;39:15333175241263741. doi: 10.1177/15333175241263741.
- 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.
Anne-Gabrielle Mittaz Hager, PhD Cand principal investigator
HES-SO Valais-Wallis
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Test and exercise home-based program in people with Alzheimer Disease, Early Onset, run by HES-SO Valais-Wallis at 1 site in Switzerland.
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: status not confirmed, as of the sponsor's last update on 8 Jun 2021. 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 Switzerland. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Anne-Gabrielle Mittaz Hager, PhD Cand (796099063 ext. 0041, gaby.mittaz@hevs.ch), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Functional mobility (time frame: 8 weeks). The study lists 4 primary outcomes in all. 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 NCT04916964, 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 8 Jun 2021.