Clinical trial NCT05751551: Feasibility and Effectiveness of a Home-based Motor-cognitive Training Program in Older Adults
Official title: Feasibility and Effectiveness of a Personalized, Home-based Motor-cognitive Training Program in Community-dwelling Older Adults - a Pragmatic Pilot Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Aged
Independent Living
Keywords: Motor-cognitive intervention
Exergames
Telerehabilitation
Lead sponsor: Swiss Federal Institute of Technology
Sponsor class: OTHER
First posted: 2023-03-02
Enrollment: 144
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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.
Primary purpose: TREATMENT

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.

Detailed description: Age-related declines in physical and cognitive functioning and the associated adverse outcomes such as restricted mobility, cognitive impairment, and falls ultimately result in a decrease of older adults' quality of life. In the light of the demographic change, these age-related declines gain special importance. Attempting to counteract these declines, previous studies have revealed that simultaneous motor and cognitive training may be equally or even more effective than separate training. In fact, simultaneous motor-cognitive training has shown to improve various physical, cognitive, and psychological functions in older adults - for instance balance, gait, executive control, processing speed, exercise enjoyment, depressive symptoms, and quality of life. However, most training programs are provided face-to-face, and accessibility is a major concern for older adults, especially in the post-pandemic era. Besides, due to the demographic change there is an increased need for long-term care/treatment challenging the health care system (in terms of finance, time, and personnel). Home-based rehabilitation programs offer a cost-effective solution to these problems.

However, previous research either investigated home-based training approaches based on separate motor-cognitive training, or, in case of simultaneous motor-cognitive training approaches, these have been tested in rather specific older populations (e.g., stroke survivors, Parkinson patients, older adults with cognitive impairment) or in healthy older adults. Yet, simultaneous motor-cognitive training in the home setting should be feasible and effective in a broader population of older adults especially in those without long-term access to traditional rehabilitation interventions accompanying them to full recovery. For this reason, this study aims to test the feasibility of a personalized, simultaneous motor-cognitive home-based training approach based on exergames for geriatric patients and to evaluate its effectiveness compared to usual care alone on physical and cognitive functions as well as on fall-related self-efficacy.

Potential participants will be screened and if eligible, asked if they are interested in partaking. All eligible and interested possible participants will be orally informed about the study and receive a written study information explaining the aim of the study, procedures, risks, and benefits of participation, as well as their rights and duties in case of participation. All participants will sign a written consent form, before any study-specific actions are performed.

The study will start with a baseline assessment. Then, participants will be randomized to either the intervention or the control group applying permuted block randomization. Subsequently, participants of the intervention group will perform 6 supervised, personalized motor-cognitive training sessions in a rehabilitation centre (ideally within 2 weeks) for about 20-30 minutes per session (familiarization period). Afterwards, participants of the intervention group will continue the training independently at home for 10 weeks, 3 times/week for about 20-30 minutes with the investigators supervising them via phone calls and regular personal visits. Physical and cognitive tests will be the basis for individual training plans which will further on be regularly adapted based on progression rules. All motor-cognitive training sessions in both intervention phases will be additional to usual care. The control group receives no additional training besides usual care. Participants of all groups will conduct 3 measurement sessions: (1) T1 (baseline assessments), (2) T2 (pre-intervention, after familiarization period, before starting the home-based training), (3) T3 (post-intervention assessment).

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

Primary outcomes:
measure: Adherence rate
timeFrame: The adherence rate is assessed for all training sessions during the home-based intervention period, approximately for 10 weeks
measure: Attrition rate
timeFrame: The attrition rate is assessed during the data collection period, an average of 12 weeks
measure: Exergame Enjoyment Questionnaire (EEQ)
timeFrame: 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:
measure: National Aeronautics and Space Administration-Task Load Index (NASA-TLX)
timeFrame: 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.
measure: Additional instructions
timeFrame: Additional instructions will be collected throughout the whole home-based intervention period, an average of 10 weeks
measure: Help requests
timeFrame: The number of help requests will be collected throughout the whole home-based intervention period, an average of 10 weeks
measure: Intention to continue the training program
timeFrame: The assessment will take place at T3 (post-measurement), thus about 12 weeks after study entry. The survey takes about 30 seconds.
measure: Changes in psychomotor speed
timeFrame: 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.
measure: Changes in selective attention
timeFrame: The assessment takes place at T2 (pre-measurement) and T3 (post-measurement), thus about after 2 and 12 weeks after study entry. The GoNogo Test lasts 5 minutes.
measure: Changes in cognitive flexibility
timeFrame: The assessment takes place at T2 (pre-measurement) and T3 (post-measurement), thus about 2 and 12 weeks after study entry. The Flexibility Test lasts 5 minutes.
measure: Changes in static balance
timeFrame: The assessment takes place at T2 (pre-measurement) and T3 (post-measurement), thus about 2 and 12 weeks after study entry. The Sway Test lasts about 1-2 minutes.
measure: Changes in dynamic balance
timeFrame: The assessment takes place at T2 (pre-measurement) and T3 (post-measurement), thus about 2 and 12 weeks after study entry. The Coordinated Stability Test lasts about 4 minutes.
measure: Changes in functional balance
timeFrame: The assessment takes place at T2 (pre-measurement) and T3 (post-measurement), thus about 2 and 12 weeks after study entry. The TUG tests take about 2 minutes.
measure: Changes in functional balance and dual task
timeFrame: The assessment takes place at T2 (pre-measurement) and T3 (post-measurement), thus about 2 and 12 weeks after study entry. The TUG-DT takes about 2 minutes.
measure: Changes in strength (Lower limb power)
timeFrame: The assessment takes place at T2 (pre-measurement) and T3 (post-measurement), thus about 2 and 12 weeks after study entry. The STS tests takes about 2 minutes.
measure: Changes in balance confidence
timeFrame: The assessment takes place at T2 (pre-measurement) and T3 (post-measurement), thus about 2 and 12 weeks after study entry. The survey lasts about 10 minutes.
Other outcomes:
Locations:
city: Zürich
country: Switzerland
facility: ETH
Study officials:
affiliation: ETH Zürich
name: Julia Seinsche, M.Sc.
role: PRINCIPAL_INVESTIGATOR
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