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

June 7, 2021 updated by: Mittaz Hager Anne-Gabrielle, HES-SO Valais-Wallis

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

12

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Anne-Gabrielle Mittaz Hager, PhD Cand
  • Phone Number: 0041 796099063
  • Email: gaby.mittaz@hevs.ch

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Functional mobility
Time Frame: 8 weeks
Berg Balance Scale (BBS), scoring ranges from 0 (worse) to 56 (best)
8 weeks
Stand and go
Time Frame: 8 weeks
Time Up and Go test (TUG) in seconds
8 weeks
Sit to stand
Time Frame: 8 weeks
Five Time Sit to Stand (FTSTS) in seconds
8 weeks
Walking speed
Time Frame: 8 weeks
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)
Time Frame: 8 weeks
Trail Making Test Part-Be in seconds
8 weeks
The updating (Working memory)
Time Frame: 8 weeks
Digit span backward task, number of the successful sequences between 0 and 14
8 weeks
The response inhibition
Time Frame: 8 weeks
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
Time Frame: 4 months
Inclusion of 12 subjects between the 30 of May 2021 ant the 30 of Septembre 2021
4 months
Participation agreement
Time Frame: 4 months
Fulfilled if 75% of eligible subjects agree to participate and sign the consent
4 months
Costs
Time Frame: 8 months
Fulfilled if the cost does not exceed the planed amounts by more than 5%
8 months
Drop out / withdraw
Time Frame: 8 months
Fulfilled if 75% of the participants take part in the total duration of the study
8 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

HES-SO Valais-Wallis

Collaborators

Hilfiker Roger

Investigators

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

June 30, 2021

Primary Completion (Anticipated)

October 30, 2021

Study Completion (Anticipated)

December 30, 2021

Study Registration Dates

First Submitted

May 31, 2021

First Submitted That Met QC Criteria

June 7, 2021

First Posted (Actual)

June 8, 2021

Study Record Updates

Last Update Posted (Actual)

June 8, 2021

Last Update Submitted That Met QC Criteria

June 7, 2021

Last Verified

June 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HOPE

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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