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

Alzheimer Disease, Early Onset Clinical Trial

— 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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04916964
• Other study ID #: HOPE
• Status: Recruiting
• Phase: N/A
• Start date: June 30, 2021
• Est. completion date: December 30, 2021

Study information

• Verified date: June 2021
• Source: HES-SO Valais-Wallis
• Contact: Anne-Gabrielle Mittaz Hager, PhD Cand
• Phone: 796099063
• Email: gaby.mittaz[@]hevs.ch
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 12
• Est. completion date: December 30, 2021
• Est. primary completion date: October 30, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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.

Related Conditions & MeSH terms

• Alzheimer Disease
• Alzheimer Disease, Early Onset

Intervention

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.

Locations

Country	Name	City	State
Switzerland	CMS Sierre Région	Sierre	Valais

Sponsors (2)

Lead Sponsor	Collaborator
HES-SO Valais-Wallis	Hilfiker Roger

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Functional mobility	Berg Balance Scale (BBS), scoring ranges from 0 (worse) to 56 (best)	8 weeks
Primary	Stand and go	Time Up and Go test (TUG) in seconds	8 weeks
Primary	Sit to stand	Five Time Sit to Stand (FTSTS) in seconds	8 weeks
Primary	Walking speed	The self-selected and the maximal walking speed (SSWS/MWS) on a 6-meter walk	8 weeks
Secondary	The Set shifting (Mental flexibility)	Trail Making Test Part-Be in seconds	8 weeks
Secondary	The updating (Working memory)	Digit span backward task, number of the successful sequences between 0 and 14	8 weeks
Secondary	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	8 weeks
Secondary	Feasibility of recruitement	Inclusion of 12 subjects between the 30 of May 2021 ant the 30 of Septembre 2021	4 months
Secondary	Participation agreement	Fulfilled if 75% of eligible subjects agree to participate and sign the consent	4 months
Secondary	Costs	Fulfilled if the cost does not exceed the planed amounts by more than 5%	8 months
Secondary	Drop out / withdraw	Fulfilled if 75% of the participants take part in the total duration of the study	8 months