NCT04916964

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
12

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jun 2021

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 31, 2021

Completed
8 days until next milestone

First Posted

Study publicly available on registry

June 8, 2021

Completed
22 days until next milestone

Study Start

First participant enrolled

June 30, 2021

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 30, 2021

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2021

Completed
Last Updated

June 8, 2021

Status Verified

June 1, 2021

Enrollment Period

4 months

First QC Date

May 31, 2021

Last Update Submit

June 7, 2021

Conditions

Alzheimer Disease, Early Onset

Keywords

Home-based exercise programBasic functional mobilityCentral executive functions

Outcome Measures

Primary Outcomes (4)

  • 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 Outcomes (7)

  • The Set shifting (Mental flexibility)

    8 weeks

  • The updating (Working memory)

    8 weeks

  • The response inhibition

    8 weeks

  • Feasibility of recruitement

    4 months

  • Participation agreement

    4 months

  • +2 more secondary outcomes

Study Arms (1)

Test & Exercise home-based program (T&E)

EXPERIMENTAL

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

Other: Test and exercise home-based program

Interventions

Test and exercise home-based programOTHER

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.

Also known as: T&E
Test & Exercise home-based program (T&E)

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CMS Sierre RĂ©gion

Sierre, Valais, 3960, Switzerland

RECRUITING

Related Publications (1)

  • Carrard S, Eyer S, Hilfiker R, Mittaz Hager AG. Adapted Home-Based Exercises in Dementia: An Exploratory Pre-post Pilot and Feasibility Study. Am J Alzheimers Dis Other Demen. 2024 Jan-Dec;39:15333175241263741. doi: 10.1177/15333175241263741.

    PMID: 38877608DERIVED

MeSH Terms

Conditions

Alzheimer Disease

Condition Hierarchy (Ancestors)

DementiaBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesTauopathiesNeurodegenerative DiseasesNeurocognitive DisordersMental Disorders

Study Officials

  • Anne-Gabrielle Mittaz Hager, PhD Cand

    HES-SO Valais-Wallis

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Anne-Gabrielle Mittaz Hager, PhD Cand

CONTACT

796099063gaby.mittaz@hevs.ch

Roger Hilfiker, PhD Cand

CONTACT

796883490roger.hilfiker@hevs.ch

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

May 31, 2021

First Posted

June 8, 2021

Study Start

June 30, 2021

Primary Completion

October 30, 2021

Study Completion

December 30, 2021

Last Updated

June 8, 2021

Record last verified: 2021-06

Data Sharing

IPD Sharing
Will not share

Locations

CH(1)