Adapted Home-based Exercise Program "T&E" (Test-and-Exercise) in Persons With Alzheimer's Disease (HOPE Trial)
- Conditions
- Alzheimer Disease, Early Onset
- Interventions
- Other: Test and exercise home-based program
- Registration Number
- NCT04916964
- Lead Sponsor
- HES-SO Valais-Wallis
- 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.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 12
- 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.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Test & Exercise home-based program (T&E) Test and exercise home-based program Eight home-based physiotherapy sessions will occur in two months, once a week
- Primary Outcome Measures
Name Time Method Sit to stand 8 weeks Five Time Sit to Stand (FTSTS) in seconds
Functional mobility 8 weeks Berg Balance Scale (BBS), scoring ranges from 0 (worse) to 56 (best)
Stand and go 8 weeks Time Up and Go test (TUG) in seconds
Walking speed 8 weeks The self-selected and the maximal walking speed (SSWS/MWS) on a 6-meter walk
- Secondary Outcome Measures
Name Time Method The Set shifting (Mental flexibility) 8 weeks Trail Making Test Part-Be in seconds
Participation agreement 4 months Fulfilled if 75% of eligible subjects agree to participate and sign the consent
Feasibility of recruitement 4 months Inclusion of 12 subjects between the 30 of May 2021 ant the 30 of Septembre 2021
Costs 8 months Fulfilled if the cost does not exceed the planed amounts by more than 5%
Drop out / withdraw 8 months Fulfilled if 75% of the participants take part in the total duration of the study
The updating (Working memory) 8 weeks Digit span backward task, number of the successful sequences between 0 and 14
The response inhibition 8 weeks Stroop Color and Word Test (SCWT) Victoria, comparison of the expected score to the participant's score to calculate the Z-score
Trial Locations
- Locations (1)
CMS Sierre Région
🇨🇭Sierre, Valais, Switzerland