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

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

Conditions
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Alzheimer Disease, Early Onset

Intervention / Treatment
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* Other: Test and exercise home-based program


Participation Criteria
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Eligibility Criteria
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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.
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Test & Exercise home-based program (T&E)<br>Eight home-based physiotherapy sessions will occur in two months, once a week | Other: Test and exercise home-based program<br>* 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.<br>* Other names: T&E;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Functional mobility | Berg Balance Scale (BBS), scoring ranges from 0 (worse) to 56 (best) | 8 weeks | 
| Stand and go | Time Up and Go test (TUG) in seconds | 8 weeks | 
| Sit to stand | Five Time Sit to Stand (FTSTS) in seconds | 8 weeks | 
| Walking speed | The self-selected and the maximal walking speed (SSWS/MWS) on a 6-meter walk | 8 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The Set shifting (Mental flexibility) | Trail Making Test Part-Be in seconds | 8 weeks | 
| The updating (Working memory) | Digit span backward task, number of the successful sequences between 0 and 14 | 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 | 8 weeks | 
| Feasibility of recruitement | Inclusion of 12 subjects between the 30 of May 2021 ant the 30 of Septembre 2021 | 4 months | 
| Participation agreement | Fulfilled if 75% of eligible subjects agree to participate and sign the consent | 4 months | 
| Costs | Fulfilled if the cost does not exceed the planed amounts by more than 5% | 8 months | 
| Drop out / withdraw | Fulfilled if 75% of the participants take part in the total duration of the study | 8 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Home-based exercise program, Basic functional mobility, Central executive functions