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

Sponsor
HES-SO Valais-Wallis (Other)
Overall Status
Recruiting
CT.gov ID
NCT04916964
Collaborator
Hilfiker Roger (Other)
12
1
1
6
2

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Other: Test and exercise home-based program
N/A

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.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
12 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
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
Anticipated Study Start Date :
Jun 30, 2021
Anticipated Primary Completion Date :
Oct 30, 2021
Anticipated Study Completion Date :
Dec 30, 2021

Arms and Interventions

Arm Intervention/Treatment
Experimental: Test & Exercise home-based program (T&E)

Eight home-based physiotherapy sessions will occur in two months, once a week

Other: Test 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.
Other Names:
  • T&E
  • Outcome Measures

    Primary Outcome Measures

    1. Functional mobility [8 weeks]

      Berg Balance Scale (BBS), scoring ranges from 0 (worse) to 56 (best)

    2. Stand and go [8 weeks]

      Time Up and Go test (TUG) in seconds

    3. Sit to stand [8 weeks]

      Five Time Sit to Stand (FTSTS) in seconds

    4. Walking speed [8 weeks]

      The self-selected and the maximal walking speed (SSWS/MWS) on a 6-meter walk

    Secondary Outcome Measures

    1. The Set shifting (Mental flexibility) [8 weeks]

      Trail Making Test Part-Be in seconds

    2. The updating (Working memory) [8 weeks]

      Digit span backward task, number of the successful sequences between 0 and 14

    3. 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

    4. Feasibility of recruitement [4 months]

      Inclusion of 12 subjects between the 30 of May 2021 ant the 30 of Septembre 2021

    5. Participation agreement [4 months]

      Fulfilled if 75% of eligible subjects agree to participate and sign the consent

    6. Costs [8 months]

      Fulfilled if the cost does not exceed the planed amounts by more than 5%

    7. Drop out / withdraw [8 months]

      Fulfilled if 75% of the participants take part in the total duration of the study

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    N/A and Older
    Sexes Eligible for Study:
    All
    Accepts 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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 CMS Sierre RĂ©gion Sierre Valais Switzerland 3960

    Sponsors and Collaborators

    • HES-SO Valais-Wallis
    • Hilfiker Roger

    Investigators

    • Principal Investigator: Anne-Gabrielle Mittaz Hager, PhD Cand, HES-SO Valais-Wallis

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Mittaz Hager Anne-Gabrielle, Professor, HES-SO Valais-Wallis
    ClinicalTrials.gov Identifier:
    NCT04916964
    Other Study ID Numbers:
    • HOPE
    First Posted:
    Jun 8, 2021
    Last Update Posted:
    Jun 8, 2021
    Last Verified:
    Jun 1, 2021
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Mittaz Hager Anne-Gabrielle, Professor, HES-SO Valais-Wallis
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Jun 8, 2021