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Adapted Home-based Exercise Program T&E (Test-and-Exercise) in Persons With Alzheimer's Disease (HOPE Trial)

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

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04916964
Acronym
HOPE
Enrollment
12
Registered
2021-06-08
Start date
2021-06-30
Completion date
2021-12-30
Last updated
2021-06-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Alzheimer Disease, Early Onset

Keywords

Home-based exercise program, Basic functional mobility, Central executive functions

Brief 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.

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.

Interventions

OTHERTest and exercise home-based program

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.

Sponsors

Hilfiker Roger
CollaboratorUNKNOWN
HES-SO Valais-Wallis
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Healthy volunteers
No

Inclusion criteria

* 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.

Exclusion criteria

* 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.

Design outcomes

Primary

MeasureTime frameDescription
Functional mobility8 weeksBerg Balance Scale (BBS), scoring ranges from 0 (worse) to 56 (best)
Stand and go8 weeksTime Up and Go test (TUG) in seconds
Sit to stand8 weeksFive Time Sit to Stand (FTSTS) in seconds
Walking speed8 weeksThe self-selected and the maximal walking speed (SSWS/MWS) on a 6-meter walk

Secondary

MeasureTime frameDescription
Participation agreement4 monthsFulfilled if 75% of eligible subjects agree to participate and sign the consent
The Set shifting (Mental flexibility)8 weeksTrail Making Test Part-Be in seconds
Drop out / withdraw8 monthsFulfilled if 75% of the participants take part in the total duration of the study
Costs8 monthsFulfilled if the cost does not exceed the planed amounts by more than 5%
The updating (Working memory)8 weeksDigit span backward task, number of the successful sequences between 0 and 14
The response inhibition8 weeksStroop Color and Word Test (SCWT) Victoria, comparison of the expected score to the participant's score to calculate the Z-score
Feasibility of recruitement4 monthsInclusion of 12 subjects between the 30 of May 2021 ant the 30 of Septembre 2021

Countries

Switzerland

Contacts

Primary ContactAnne-Gabrielle Mittaz Hager, PhD Cand
gaby.mittaz@hevs.ch796099063
Backup ContactRoger Hilfiker, PhD Cand
roger.hilfiker@hevs.ch796883490

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 7, 2026