Clinical trial NCT03676452: The Effects of an Exergame Training on Body and Brain of Older Adults
Official title: The Effects of a Home-based Multicomponent Exergame Training on Motor Functions, Cognition, and Brain Structure of Older Adults: A Multinational Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Fall Prevention in Healthy Aging
Lead sponsor: Swiss Federal Institute of Technology
Sponsor class: OTHER
First posted: 2018-09-18
Enrollment: 37
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: This is a two-arm randomized controlled trial with an intervention group and a usual care waitlist control group. After pre-measurement, participants of the intervention group train for four months with the Active@Home exergame. Participants of the control group are instructed to continue their usual daily business and activities. Then, post-measurement takes place. After post-measurement, participants of the control group get the Active@Home exergame for their personal use at home (for several months, no additional measurement).
Primary purpose: PREVENTION

Brief summary: This study investigates the effects of an exergame training including strength, balance, and cognitive training components on motor functions, cognition and brain structure of older adults. The primary objective is to determine the effects of the home-based multicomponent exergame training on motor and cognitive functions of older adults compared to a usual care waitlist control group. To understand the underlying mechanisms, the secondary objective is to assess the effect of the exergame training on neuronal level (brain structure). The study design is a randomized controlled trial including 40 healthy (self-reported), independently living older adults aged 65 years and older. The intervention period lasts for 16-18 weeks (no longer than two weeks of break/holiday allowed) with three training sessions per week each lasting about 40 minutes.

Detailed description: Age-associated degenerative changes cause gait impairments and a higher risk of falls in elderly. Falls are a leading cause for injuries, reduced mobility, independence and general well-being. Most of the investigator's daily life activities, including walking, are tasks which require not only motor but also cognitive functions. Therefore, also in fall prevention, there is a need for combined motor-cognitive interventions. Exergames - games which require physical activity and movement to play the game - are a promising option for motivating and engaging motor-cognitive training, especially in combination with newly available technologies. In an international project of the Ambient Assisted Living Association (AAL), a new exergame (Active@Home) was developed which ultimately aims for fall prevention in elderly and incorporates theoretical background from movement sciences, neuropsychology, cognitive sciences, and arts of game design.

During aging, age-related changes are evident not only in sensory, motor and cognitive functions but also on (underlying) neuronal level: The aging brain is associated with neurostructural changes and functional changes in neuronal activity pattern. Especially the (pre)frontal lobe and medial temporal lobe (Hippocampus) are vulnerable to age-related degeneration. However, also in higher age, experience-based neuroplasticity can be observed; the adult brain possesses the ability to alter cortical functions and structures in response to stimulation or training. Evidence shows that experience-dependent neural plasticity can be enhanced by both, physical and cognitive exercise. The question arises how a combination of both - combined motor-cognitive training - influences neuroplasticity in the aging brain. Exergame training has been shown to improve motor as well as cognitive functions. To understand the underlying mechanisms of these training effects, the impact on the level of neuronal activity and brain structure has to be studied.

The primary objective of this study is to determine the effects of a home-based multicomponent exergame training on motor and cognitive functions of older adults compared to a usual care waitlist control group.

To understand the underlying mechanisms, the secondary objective is to assess the effect of the exergame training on neuronal level (brain structure).

The Active@Home exergame is a multicomponent, motor-cognitive training for fall prevention in elderly adults. It mainly consists of three components; strength training, balance training and cognitive training. For strength training, Tai Chi-based movements are included as Tai Chi is mainly performed in a semi-squat posture that places a large load on the muscles of the lower extremities. For balance training, dancing is included in the Active@Home exergame as the execution of rapid and well-directed steps has been shown to be effective in preventing falls. Both, Tai Chi and dancing, are 'holistic' physical activities requiring motor functions, cognition and mental involvement. Moreover, the Active@Home exergame explicitly targets specific attentional and executive functions (selective attention, divided attention, inhibition/interference control, mental flexibility, working memory) which are important for walking and safe gait. To maximize benefits for participants, the Active@Home exergame implements some basic general training principles; providing feedback, optimal load of task demands, progression of difficulty and high variability. The Active@Home system set up is easy and consists of an HDMI dongle (to run the application) which must be plugged into the TV and four wearable sensors (to measure the movements).

All interested participants will be screened for eligibility for the study (cognitive screening with MMSE, health screening with questionnaire). Then the eligible participants are randomly allocated to either the intervention group or the waitlist control group. At the first appointment (T1), pre-measurements are conducted (motor and cognitive functions, MRI scans) with all participants. The participants of the intervention group will be equipped with the Active@Home exergame kit and instructed how to set up and use the system at home. The intervention period lasts for 16-18 weeks (no longer than two weeks of break/holiday allowed) with three training sessions per week each lasting about 40 minutes. All participants have to fill in an activity protocol during the whole intervention period. After completing all training sessions (in the intervention group), post-measurements are conducted at T2 with all participants. Measurements will take place at the CERENEO (Swiss clinic and research institute at Vitznau, Lucerne). Participants of the waitlist control group are instructed to continue their usual daily business and activities during the study period. After the post-measurements, they will get the Active@Home exergame for their personal use at home (for several months).

Eligibility criteria: Inclusion Criteria:

* Age ≥ 65 years
* Living independently
* Healthy by self-report
* Able to stand unsupported on feet for at least 10-15 minutes
* Written informed consent signed by the participant
* Not participating in a guided existing physical or cognitive training program
* Possess a TV screen with HDMI connection and some space in front of the screen

Exclusion Criteria:

* Cognitive impairments (Mini Mental State Examination, MMSE ≤ 23)
* Severe health problems (e.g. recent cardiac infarction, uncontrolled diabetes or uncontrolled hypertension)
* Orthopaedic disease leading to mobility impairments (that prevent to stand unsupported on feet for at least 10-15 minutes)
* Neurological disease (e.g. history of stroke or epilepsy, Parkinson disease)
* Alzheimer disease or other forms of dementia
* Acute severe illness
* Rapidly progressive or terminal illness
* Intake of any psychoactive substances (neuroleptics, antidepressants etc.) with an influence on neuroplasticity
* Active participation in a guided strength-balance-aerobic endurance or cognitive training program
* Contraindication for MRI: Any metallic parts within the body, metallic or electronic implants (e.g. heart pacemaker, brain pacemaker, cochlear implants), shunts, stents, protheses, ferromagnetic remnants within the body, strong claustrophobia

Primary outcomes:
measure: Change in gait speed
timeFrame: Assessment takes place at pre- and post-measurement within two weeks before and after the intervention. Pre- and post-measurement changes are calculated. The gait analysis lasts 5 minutes.
measure: Change in balance
timeFrame: Assessment takes place at pre- and post-measurement within two weeks before and after the intervention. Pre- and post-measurement changes are calculated. The balance test lasts 3 minutes.
measure: Change in lower body strength
timeFrame: Assessment takes place at pre- and post-measurement within two weeks before and after the intervention. Pre- and post-measurement changes are calculated. The lower body strength test lasts 1 minute.
measure: Change in aerobic endurance
timeFrame: Assessment takes place at pre- and post-measurement within two weeks before and after the intervention. Pre- and post-measurement changes are calculated. The aerobic endurance test lasts 3 minutes.
measure: Change in step length
timeFrame: Assessment takes place at pre- and post-measurement within two weeks before and after the intervention. Pre- and post-measurement changes are calculated. The gait analysis lasts 5 minutes.
measure: Change in minimal toe clearance
timeFrame: Assessment takes place at pre- and post-measurement within two weeks before and after the intervention. Pre- and post-measurement changes are calculated. The gait analysis lasts 5 minutes.
measure: Change in mental flexibility
timeFrame: Assessment takes place at pre- and post-measurement within two weeks before and after the intervention. Pre- and post-measurement changes are calculated. The TMT lasts 5 minutes.
measure: Change in interference control
timeFrame: Assessment takes place at pre- and post-measurement within two weeks before and after the intervention. Pre- and post-measurement changes are calculated. The VST lasts 5 minutes.
measure: Change in memory functions
timeFrame: Assessment takes place at pre- and post-measurement within two weeks before and after the intervention. Pre- and post-measurement changes are calculated. The WMS-R lasts 5 minutes.
Secondary outcomes:
measure: Change in grey matter brain structure
timeFrame: Assessment takes place at pre- and post-measurement within two weeks before and after the intervention. Pre- and post-measurement changes are calculated. The T1-weighted sequence lasts 5 minutes.
measure: Change in white matter brain structure
timeFrame: Assessment takes place at pre- and post-measurement within two weeks before and after the intervention. Pre- and post-measurement changes are calculated. The T2-weighted sequences last 10 minutes.
Other outcomes:
Locations:
city: Zürich
country: Switzerland
facility: Institute of Human Movement Sciences and Sport, ETH Zurich
Study officials:
References: