Clinical trial NCT04916964: Adapted Home-based Exercise Program "T&E" (Test-and-Exercise) in Persons With Alzheimer's Disease (HOPE Trial)
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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Alzheimer Disease, Early Onset
Keywords: Home-based exercise program
Basic functional mobility
Central executive functions
Lead sponsor: HES-SO Valais-Wallis
Sponsor class: OTHER
Collaborators: name: Hilfiker Roger
First posted: 2021-06-08
Enrollment: 12
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Functional mobility
timeFrame: 8 weeks
measure: Stand and go
timeFrame: 8 weeks
measure: Sit to stand
timeFrame: 8 weeks
measure: Walking speed
timeFrame: 8 weeks
Secondary outcomes:
measure: The Set shifting (Mental flexibility)
timeFrame: 8 weeks
measure: The updating (Working memory)
timeFrame: 8 weeks
measure: The response inhibition
timeFrame: 8 weeks
measure: Feasibility of recruitement
timeFrame: 4 months
measure: Participation agreement
timeFrame: 4 months
measure: Costs
timeFrame: 8 months
measure: Drop out / withdraw
timeFrame: 8 months
Other outcomes:
Locations:
city: Sierre
country: Switzerland
facility: CMS Sierre Région
state: Valais
Study officials:
affiliation: HES-SO Valais-Wallis
name: Anne-Gabrielle Mittaz Hager, PhD Cand
role: PRINCIPAL_INVESTIGATOR
References: