Adapted Home-based Exercise Program "T&E" (Test-and-Exercise) in Persons With Alzheimer's Disease (HOPE Trial) (HOPE)
Primary Purpose
Alzheimer Disease, Early Onset
Status
Unknown status
Phase
Not Applicable
Locations
Switzerland
Study Type
Interventional
Intervention
Test and exercise home-based program
Sponsored by
About this trial
This is an interventional treatment trial for Alzheimer Disease, Early Onset focused on measuring Home-based exercise program, Basic functional mobility, Central executive functions
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.
Sites / Locations
- CMS Sierre RégionRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Test & Exercise home-based program (T&E)
Arm Description
Eight home-based physiotherapy sessions will occur in two months, once a week
Outcomes
Primary Outcome Measures
Functional mobility
Berg Balance Scale (BBS), scoring ranges from 0 (worse) to 56 (best)
Stand and go
Time Up and Go test (TUG) in seconds
Sit to stand
Five Time Sit to Stand (FTSTS) in seconds
Walking speed
The self-selected and the maximal walking speed (SSWS/MWS) on a 6-meter walk
Secondary Outcome Measures
The Set shifting (Mental flexibility)
Trail Making Test Part-Be in seconds
The updating (Working memory)
Digit span backward task, number of the successful sequences between 0 and 14
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
Feasibility of recruitement
Inclusion of 12 subjects between the 30 of May 2021 ant the 30 of Septembre 2021
Participation agreement
Fulfilled if 75% of eligible subjects agree to participate and sign the consent
Costs
Fulfilled if the cost does not exceed the planed amounts by more than 5%
Drop out / withdraw
Fulfilled if 75% of the participants take part in the total duration of the study
Full Information
NCT ID
NCT04916964
First Posted
May 31, 2021
Last Updated
June 7, 2021
Sponsor
HES-SO Valais-Wallis
Collaborators
Hilfiker Roger
1. Study Identification
Unique Protocol Identification Number
NCT04916964
Brief Title
Adapted Home-based Exercise Program "T&E" (Test-and-Exercise) in Persons With Alzheimer's Disease (HOPE Trial)
Acronym
HOPE
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
2. Study Status
Record Verification Date
June 2021
Overall Recruitment Status
Unknown status
Study Start Date
June 30, 2021 (Anticipated)
Primary Completion Date
October 30, 2021 (Anticipated)
Study Completion Date
December 30, 2021 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
HES-SO Valais-Wallis
Collaborators
Hilfiker Roger
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alzheimer Disease, Early Onset
Keywords
Home-based exercise program, Basic functional mobility, Central executive functions
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
12 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Test & Exercise home-based program (T&E)
Arm Type
Experimental
Arm Description
Eight home-based physiotherapy sessions will occur in two months, once a week
Intervention Type
Other
Intervention Name(s)
Test and exercise home-based program
Other Intervention Name(s)
T&E
Intervention Description
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.
Primary Outcome Measure Information:
Title
Functional mobility
Description
Berg Balance Scale (BBS), scoring ranges from 0 (worse) to 56 (best)
Time Frame
8 weeks
Title
Stand and go
Description
Time Up and Go test (TUG) in seconds
Time Frame
8 weeks
Title
Sit to stand
Description
Five Time Sit to Stand (FTSTS) in seconds
Time Frame
8 weeks
Title
Walking speed
Description
The self-selected and the maximal walking speed (SSWS/MWS) on a 6-meter walk
Time Frame
8 weeks
Secondary Outcome Measure Information:
Title
The Set shifting (Mental flexibility)
Description
Trail Making Test Part-Be in seconds
Time Frame
8 weeks
Title
The updating (Working memory)
Description
Digit span backward task, number of the successful sequences between 0 and 14
Time Frame
8 weeks
Title
The response inhibition
Description
Stroop Color and Word Test (SCWT) Victoria, comparison of the expected score to the participant's score to calculate the Z-score
Time Frame
8 weeks
Title
Feasibility of recruitement
Description
Inclusion of 12 subjects between the 30 of May 2021 ant the 30 of Septembre 2021
Time Frame
4 months
Title
Participation agreement
Description
Fulfilled if 75% of eligible subjects agree to participate and sign the consent
Time Frame
4 months
Title
Costs
Description
Fulfilled if the cost does not exceed the planed amounts by more than 5%
Time Frame
8 months
Title
Drop out / withdraw
Description
Fulfilled if 75% of the participants take part in the total duration of the study
Time Frame
8 months
10. Eligibility
Sex
All
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Anne-Gabrielle Mittaz Hager, PhD Cand
Phone
796099063
Ext
0041
Email
gaby.mittaz@hevs.ch
First Name & Middle Initial & Last Name or Official Title & Degree
Roger Hilfiker, PhD Cand
Phone
796883490
Ext
0041
Email
roger.hilfiker@hevs.ch
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Anne-Gabrielle Mittaz Hager, PhD Cand
Organizational Affiliation
HES-SO Valais-Wallis
Official's Role
Principal Investigator
Facility Information:
Facility Name
CMS Sierre Région
City
Sierre
State/Province
Valais
ZIP/Postal Code
3960
Country
Switzerland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Laurence Adler, MSc
Phone
791371027
Ext
0041
Email
laurence.adler@cms-smz.ch
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Adapted Home-based Exercise Program "T&E" (Test-and-Exercise) in Persons With Alzheimer's Disease (HOPE Trial)
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