Feasibility and Effectiveness of a Home-based Motor-cognitive Training Program in Older Adults

NCT05751551 | Completed DMC

• 1 other identifier: BASEC-Nr. 2022-01746
• Study Type: interventional
• Target: 144
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this clinical study is to test feasibility and effectiveness of a personalized, home-based motor-cognitive training program in community-dwelling older adults with prescription for rehabilitation. Participants will conduct a motor-cognitive intervention program which is based on exergames (=interactive video games controlled by body movements), added to usual care for 2 weeks in rehabilitation centers (face-to-face supervision) and for 10 weeks at home (remotely supervised). Researchers will compare an intervention group and a control group to compare possible effects of the home-based study intervention to the effect of usual care alone on cognition, physical functions, and balance confidence.

Conditions

Aged; Independent Living

Keywords

Motor-cognitive intervention; Exergames; Telerehabilitation

Outcome Measures

Primary Outcomes (3)

• Adherence rate

  The duration of completed training sessions as percentages of the recommended duration of training sessions.

  The adherence rate is assessed for all training sessions during the home-based intervention period, approximately for 10 weeks

• Attrition rate

  Number of participants lost during the trial will be recorded (drop-outs in both groups)

  The attrition rate is assessed during the data collection period, an average of 12 weeks

• Exergame Enjoyment Questionnaire (EEQ)

  The EEQ will be used to measure exergame enjoyment in participants of the intervention group. The questionnaire consists of 20 statements rated on a five-point Likert scale which results in a minimum possible score of 20 and a maximum possible score of 100. A higher score reflects greater exergame enjoyment.

  The EEQ is completed by the intervention group at T3 (post-measurement), thus about 12 weeks after study entry. The survey lasts 5-10 minutes

Secondary Outcomes (13)

• National Aeronautics and Space Administration-Task Load Index (NASA-TLX)

  The NASA-TLX is completed by the intervention group at T3 (post-measurement), thus about 12 weeks after study entry. The survey lasts 5-10 minutes.

• Additional instructions

  Additional instructions will be collected throughout the whole home-based intervention period, an average of 10 weeks

• Help requests

  The number of help requests will be collected throughout the whole home-based intervention period, an average of 10 weeks

• Intention to continue the training program

  The assessment will take place at T3 (post-measurement), thus about 12 weeks after study entry. The survey takes about 30 seconds.

• Changes in psychomotor speed

  The assessment takes place at T2 (pre-measurement) and T3 (post-measurement), thus about 2 and 12 weeks after study entry. The RTT lasts 5 minutes.

Study Arms (2)

Intervention group

EXPERIMENTAL

The intervention group will conduct a motor-cognitive training program added to usual care. The intervention starts with a familiarization period in rehabilitation centers (face-to-face supervision) for 2 weeks before participants of the intervention group continue it at home (under remote supervision) for 10 weeks with 3 training sessions per week for about 20-30 minutes. Besides, participants of the intervention group will participate in 3 assessment sessions: (1) T1 (baseline assessments), (2) T2 (pre-intervention, after familiarization period, before starting the home-based training), (3) T3 (post-intervention assessment).

Other: Personalized, home-based motor-cognitive training

Control group

NO INTERVENTION

The control group will continue with their usual care. Apart from that, they will only attend 3 assessment sessions: (1) T1 (baseline assessments), (2) T2 (pre-intervention, after familiarization period, before starting the home-based training), (3) T3 (post-intervention assessment).

Interventions

Personalized, home-based motor-cognitive training OTHER

The simultaneous motor-cognitive training in this study will be conducted in form of exergames (interactive video games) using Senso hardware (DIV-SENSO-H, Dividat GmbH, Schindellegi, Switzerland) - a stepping platform with 5 pressure sensitive plates which is connected to a screen. For the home-based training, a more mobile version of the Dividat Senso will be used: a foldable pressure-sensitive mat. In both devices, stimuli of exergames appear on the screen and the participants have to react by stepping in one of 4 directions (front, back, left, right). The motor-cognitive training approach allows targeting different cognitive functions such as attention, executive functions, memory, and visuo-spatial functions as well as balance, and strength. FITT-VP principles will serve as a guideline but based on the functional status of each participant (physical and cognitive), the training sessions will be personalized in terms of training content, intensity and duration.

Intervention group

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patient with prescription for rehabilitation (as in- or outpatient)
• Mini-Mental State Examination (MMSE) score ≥ 24
• Physically able to independently stand for at least 2 minutes
• Able to give informed consent as documented by signature
• Access to the internet at home
• Availability of a TV or large screen at home

You may not qualify if:

• Nursing home resident
• Mobility limitations or comorbidities impairing the ability to conduct a step-based motor-cognitive training
• Cognitive limitations or comorbidities impairing the ability to conduct a step-based motor-cognitive training
• Previous or current major psychiatric illness (e.g., schizophrenia, bipolar disorder, recur-rent major depression episodes)
• History of drug or alcohol abuse
• Terminal illness
• Severe sensory impairments
• Participation in another clinical trial/intervention study
• More than 2 weeks absence in the next 3-4 months

Sponsors & Collaborators

• Swiss Federal Institute of Technology: lead

Study Sites (1)

ETH

Zurich, 8093, Switzerland

Location

Related Publications (21)

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  PMID: 37943591 DERIVED

Study Officials

• Julia Seinsche, M.Sc.

  ETH Zürich

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: This study will be conducted as an international, pragmatic pilot randomized controlled trial with two treatment arms, an intervention group (IG) and a control group (CG). It comprises a two-week intervention period in a rehabilitation clinic (for familiarization purpose) followed by a 10-week training period at home. It involves three trial partners: ETH Zürich, Don Carlo Gnocchi Foundation (Fondazione Don Carlo Gnocchi (FDG), Milan, Italy), and Materia Agecare ((MAT), Nicosia, Cyprus). The study conduction will take place at all three trial sites.

Study Record Dates

• First Submitted: December 1, 2022
• First Posted: March 2, 2023
• Study Start: February 22, 2023
• Primary Completion: January 31, 2024
• Study Completion: February 9, 2024
• Last Updated: February 15, 2024

Record last verified: 2024-02

Locations

CH (1)