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Clinical Trials/NCT04916964
NCT04916964
Unknown
N/A

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

HES-SO Valais-Wallis1 site in 1 country12 target enrollmentJune 30, 2021

Overview

Phase
N/A
Intervention
Not specified
Conditions
Alzheimer Disease, Early Onset
Sponsor
HES-SO Valais-Wallis
Enrollment
12
Locations
1
Primary Endpoint
Sit to stand
Last Updated
4 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
June 30, 2021
End Date
December 30, 2021
Last Updated
4 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Mittaz Hager Anne-Gabrielle

Professor

HES-SO Valais-Wallis

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.

Outcomes

Primary Outcomes

Sit to stand

Time Frame: 8 weeks

Five Time Sit to Stand (FTSTS) in seconds

Functional mobility

Time Frame: 8 weeks

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

Stand and go

Time Frame: 8 weeks

Time Up and Go test (TUG) in seconds

Walking speed

Time Frame: 8 weeks

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

Secondary Outcomes

  • The Set shifting (Mental flexibility)(8 weeks)
  • Participation agreement(4 months)
  • Feasibility of recruitement(4 months)
  • Costs(8 months)
  • The response inhibition(8 weeks)
  • The updating (Working memory)(8 weeks)
  • Drop out / withdraw(8 months)

Study Sites (1)

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