The Effects of an Exergame Training on Body and Brain of Older Adults

NCT03676452 | Completed DMC

• 1 other identifier: BASEC-Nr. 2018-00510
• Study Type: interventional
• Target: 37
• Locations: 1 country
• Sites: 1

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.

Conditions

Fall Prevention in Healthy Aging

Outcome Measures

Primary Outcomes (9)

• Change in gait speed

  Gait analysis is conducted under single- and dual-task condition and temporal-spatial gait parameters (gait speed, step length, toe clearance) are measured. Gait analysis is conducted with the Physilog. Gait speed is measured in m/s.

  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.

• Change in balance

  To assess balance, the balance test of the Short Physical Performance Battery (SPPB) is used resulting an a total score of 4 points for the balance tasks (e.g. tandem stance, semit tandem stance, single leg stance). A higher score means a better balance performance.

  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.

• Change in lower body strength

  Lower body strength is measured by the 30 Seconds Chair Rises Test of the Senior Fitness Test (SFT) resulting in a number of chair rises participants can perform in 30 seconds.

  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.

• Change in aerobic endurance

  Aerobic endurance is assessed by the 2 Minutes Stepping Test of the Senior Fitness Test (SFT) resulting in a number of steps done by the participants in 2 minutes.

  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.

• Change in step length

  Gait analysis is conducted under single- and dual-task condition and temporal-spatial gait parameters (gait speed, step length, toe clearance) are measured. Gait analysis is conducted with the Physilog. Step length is measured in m.

  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.

• Change in minimal toe clearance

  Gait analysis is conducted under single- and dual-task condition and temporal-spatial gait parameters (gait speed, step length, toe clearance) are measured. Gait analysis is conducted with the Physilog. Minimal toe clearance is measured in cm. Smaller values are related to higher risk of tripping and falling.

  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.

• Change in mental flexibility

  To assess mental flexibility (a part of executive functions), the Trail Making Test (TMT) is used pre- and post-intervention. This paper-pencil-test is resulting in a time value in seconds. Less time needed to conducted the test is related to better performance.

  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.

• Change in interference control

  To assess interference control (a part of executive functions), the Victoria Stroop Test (VST) is used pre- and post-intervention. The result is a time value measured in seconds, furthermore, errors are counted. Less time and less errors is related to better performance.

  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.

• Change in memory functions

  To assess memory functions, the Wechsler-Memory-Sclae-Revised (WMS-R) is used pre- and post-intervention. The test is resulting in a point score. The maximal point score is 12 points, the minimal point score is 0. Higher scores are related to better performance.

  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 (2)

• Change in grey matter brain structure

  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.

• Change in white matter brain structure

  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.

Study Arms (2)

Intervention group

EXPERIMENTAL

Participants of the intervention group train for 16 weeks (three times per week) with a multicomponent virtual reality-based exergame at their home. The Active@Home exergame contains strength training with Tai Chi-based exercises, balance training with dancing and a cognitive training with specific cognitive-motor games. Each training session lasts about 30 to 40 minutes.

Behavioral: Active@Home exergame training

Control group

NO INTERVENTION

Participants of the control group go on with their usual daily life. After post-measurements, they get the Active@Home exergame to use the training system at home. They don't have to follow a specific training plan.

Interventions

Active@Home exergame training BEHAVIORAL

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. For balance training, dancing is included in the Active@Home exergame. Moreover, the Active@Home exergame explicitly targets specific attentional and executive functions. 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).

Intervention group

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Eling DeBruin: lead

Study Sites (1)

Institute of Human Movement Sciences and Sport, ETH Zurich

Zurich, 8093, Switzerland

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor

Model Details: 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).

Study Record Dates

• First Submitted: August 27, 2018
• First Posted: September 18, 2018
• Study Start: July 1, 2018
• Primary Completion: April 18, 2019
• Study Completion: April 18, 2019
• Last Updated: April 19, 2019

Record last verified: 2019-04

Locations

CH (1)