Feasibility and Effectiveness of a Personalized, Home-based Motor-cognitive Training Program in Community-dwelling Older Adults - a Pragmatic Pilot Randomized Controlled Trial
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- Aged
- Sponsor
- Swiss Federal Institute of Technology
- Enrollment
- 144
- Locations
- 1
- Primary Endpoint
- Attrition rate
- Status
- Completed
- Last Updated
- 2 years ago
Overview
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).
Investigators
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
Outcomes
Primary Outcomes
Attrition rate
Time Frame: The attrition rate is assessed during the data collection period, an average of 12 weeks
Number of participants lost during the trial will be recorded (drop-outs in both groups)
Adherence rate
Time Frame: The adherence rate is assessed for all training sessions during the home-based intervention period, approximately for 10 weeks
The duration of completed training sessions as percentages of the recommended duration of training sessions.
Exergame Enjoyment Questionnaire (EEQ)
Time Frame: 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
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.
Secondary Outcomes
- Additional instructions(Additional instructions will be collected throughout the whole home-based intervention period, an average of 10 weeks)
- Changes in functional balance and dual task(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.)
- 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 strength (Lower limb power)(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.)
- 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.)
- Changes in cognitive flexibility(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.)
- Changes in balance confidence(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.)
- Help requests(The number of help requests will be collected throughout the whole home-based intervention period, an average of 10 weeks)
- Changes in selective attention(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.)
- Changes in static balance(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.)
- Changes in functional balance(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.)
- 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.)
- Changes in dynamic balance(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.)