Clinical trial NCT03765398: VR-CogMoBal Training for Reducing Falls Among Older Adults With Mild Cognitive Impairment
Official title: Virtual-reality Based Cognitive-motor-balance (VR-CogMoBal) Training: Examining Behavioral and Neuromarkers for Fall-risk Reduction in Older Adults With Mild Cognitive Impairment
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Mild Cognitive Impairment
Keywords: Dual-task training
Virtual-reality exergaming
Cognitive-motor-balance training
Mild cognitive impairment
Older adults
Lead sponsor: University of Illinois at Chicago
Sponsor class: OTHER
Collaborators: name: National Institute on Aging (NIA)
First posted: 2018-12-05
Enrollment: 27
Sex: ALL
Minimum age (years): 55
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Older adults often display gait instability, impaired balance control and cognitive decline that lead to falls and fall risks. Approximately 60% of the elderly people with cognitive deficits experience a detrimental fall each year. Such motor and cognitive impairments further decreases physical activity levels in this population leading to restricted community integration, social behavior, depression and long-term disability. With the help of computer technology, studies have employed virtual-reality based interventions to address the above-mentioned concerns including sensori-motor, balance control and cognitive impairments. Previous studies have demonstrated promising results on improving the behavioral outcomes, and have identified such interventions have the potential to improve the underlying neurophysiological outcomes as well. While VR based training studies have demonstrated remarkable improvement in the balance control and gait parameters, physical activity levels and fall risk reduction, the gains on cognitive function is less pronounced. There is little evidence that VR-based training can explicitly address the higher executive cognitive domains associated with balance control and falls. Further, the effect of VR-based training on balance control and cognitive function is unknown among the older adults with mild cognitive impairment. Therefore, to address the cognitive domains explicitly, the current study aims to test the applicability of Wii-Fit Nintendo along with an additional cognitive load delivered via VR-based cognitive-motor training paradigm (VR-CogMoBal) in older adults with mild cognitive impairment. Lastly, the study also aims to identify the effect of such training on the underlying behavioral and neural outcomes. The behavioral outcomes will be assessed via performance on dual-tasking and clinical measures in the laboratory. The underlying neural outcomes will be assessed via fMRI outcomes. In order to determine the generalizing training effect at community level, a pilot sub-study to determine the physical activity levels post 4 weeks of training will also be conducted.

Detailed description: Older adults suffer from mild cognitive impairments with a prevalence rate of 3% to 22% and an incidence rate of 1% to 6% per year in the United States. Along with age associated locomotor-balance impairments, such cognitive decline among the elderly is known to increase the risk of falls, reduced physical activity and community integration, thus contributing to long-term disability. Daily living activities comprises of several concurrent motor and cognitive performances (dual-tasking) such as shopping in a supermarket, that requires higher executive cognitive functions and intact locomotor-balance control abilities. Falls during dual-tasking occur mostly due to the interference caused, i.e. during dual-task performances, either one or both task (motor or cognitive) performance is deteriorated that is known as cognitive-motor interference. Given that dual-task performances decline due to age-associated factors, daily living activities are highly challenging and difficult to perform for older adults with mild cognitive impairment. Although there are several conventional methods that incorporate locomotor-balance training, the nature of such interventions does not result in pronounced cognitive gains. Additionally, these interventions lack multi-sensory feedback, and due to the monotonous and repeated task practice of exercises characteristic, individuals do not seem to adhere to therapy leading to less compliance and decreased motivation to exercise training. In order to overcome such barriers, alternate form of therapy with the help of Virtual-reality devices, especially off the shelf commercially available exercise platforms emerged for training purposes. Although there is evidence that VR based training improves locomotor-balance control and is known to implicitly address cognitive functions, there is no knowledge that such VR based training can explicitly address higher executive cognitive functions. Therefore, based on preliminary studies tested the efficacy of cognitive training along with exergaming delivered via the commercially available off the shelf device- Wii-fit Nintendo and demonstrated promising results in improving balance control and cognitive function among the individuals with Chronic Stroke. The study resulted in decreased cognitive-motor interference during dual-task performance thereby exhibiting an improved performance on both cognitive and balance control function. Currently, there is lack of knowledge in determining specific interventions for improving dual-task performances among the older adults with MCI. Given that mild cognitive impaired older adults suffer from both motor and cognitive impairments, there is a need for testing the feasibility of a similar intervention among them and determine the change in the underlying neural biomarkers.

Aim 1: The study is designed to test the feasibility (tolerability, compliance and effectiveness) of VR-CogMoBal training to improve physical function and reduce fall-risk in community-dwelling older adults with mild cognitive deficits by lowering cognitive-motor interference and dual task costs.

Hypothesis: Participants will tolerate the training paradigm and will demonstrate significant improvements in balance, gait, cardiovascular and cognitive performance under dual-task conditions.

Aim 2: To examine if the (VR-CogMoBal) will lead to higher cognitive function post-intervention.

Hypothesis: Post-training compared to pre-training participants will show significantly greater global cognitive function, executive and working memory and decreased cognitive-motor load.

Aim 3: To examine effect of VR-CogMoBal Training on changes in structural and functional connectivity within the cognitive-motor areas in the brain.

Hypothesis: Post-training compared to pre-training, participants will show increased structural and functional connectivity at rest in the default mode network (memory consolidation, self-referential memory), fronto-parietal and supplementary motor areas (motor planning and execution, attention).

Pilot Sub-study aim:

The study aims to monitor the change in the number of steps taken a day before undergoing VR training and 4 weeks post-training.

Eligibility criteria: Inclusion Criteria:

* MOCA less than 26 out of 30
* Bone density with a T-score ≥ -2.5
* Can understand and communicate in English
* Ability to stand for at least 5 minutes without an assistive device (length of a Wii Fit game)

Exclusion Criteria:

* any acute or chronic neurological (Stroke, Parkinson's disease, Alzheimer's disease), cardiopulmonary, musculoskeletal, or systemic diagnosis
* recent major surgery (\< 6 months) or hospitalization (\< 3 months)
* Use of any sedative drugs
* HR \> 85% of age-predicted maximal heart rate (HRmax) (HRmax = 220 - age)
* systolic blood pressure (SBP) \> 165 mmHg and/or diastolic blood pressure (DBP) \> 110 mmHg during resting), and/or oxygen saturation (measured by pulse oximeter) during resting \< 90%
* Specific to MRI: Self-reported presence of pacemaker, metal implants, and/or Claustrophobia

Primary outcomes:
measure: Change in Movement velocity
timeFrame: Baseline (Week 0) and Immediate Post-training (Week 5)
measure: Change in end point excursion
timeFrame: Baseline (Week 0) and Immediate Post-training (Week 5)
measure: Change in maximum excursion
timeFrame: Baseline (Week 0) and Immediate Post-training (Week 5)
measure: Change in directional control
timeFrame: Baseline (Week 0) and Immediate Post-training (Week 5)
measure: Change in postural stability during reactive balance control (single and dual-task)
timeFrame: Baseline (Week 0) and Immediate Post-training (Week 5)
measure: Change in 4 meter walk test
timeFrame: Baseline (Week 0) and Immediate Post-training (Week 5)
measure: Change in gait parameters
timeFrame: Baseline (Week 0) and Immediate Post-training (Week 5)
measure: Change of accuracy in letter number sequencing
timeFrame: Baseline (Week 0) and Immediate Post-training (Week 5)
measure: Change in accuracy of Auditory stroop
timeFrame: Baseline (Week 0) and Immediate Post-training (Week 5)
measure: Change in dual-task cost
timeFrame: Baseline (Week 0) and Immediate Post-training (Week 5)
measure: Change in Interference in the reaction time
timeFrame: Baseline (Week 0) and Immediate Post-training (Week 5)
measure: Change in language fluency
timeFrame: Baseline (Week 0) and Immediate Post-training (Week 5)
measure: Change in reaction time
timeFrame: Baseline (Week 0) and Immediate Post-training (Week 5)
measure: Change in paired associated learning
timeFrame: Baseline (Week 0) and Immediate Post-training (Week 5)
measure: Change in spatial working memory
timeFrame: Baseline (Week 0) and Immediate Post-training (Week 5)
measure: Change in working memory
timeFrame: Baseline (Week 0) and Immediate Post-training (Week 5)
measure: Change in episodic memory
timeFrame: Baseline (Week 0) and Immediate Post-training (Week 5)
measure: Change in accuracy of flanker inhibitory control and attention test
timeFrame: Baseline (Week 0) and Immediate Post-training (Week 5)
measure: Change in cognitive flexibility and attention
timeFrame: Baseline (Week 0) and Immediate Post-training (Week 5)
measure: Change in processing speed
timeFrame: Baseline (Week 0) and Immediate Post-training (Week 5)
measure: Changes in fractional anisotropy
timeFrame: Baseline (Week 0) and Immediate Post-training (Week 5)
Secondary outcomes:
measure: Berg Balance scale
timeFrame: Baseline (Week 0) and Immediate Post-training (Week 5)
measure: Change in physical activity level (Questionnaires)
timeFrame: Baseline (Week 0) and Immediate Post-training (Week 5)
measure: Change in physical activity level
timeFrame: Baseline (Week 0) and 4 weeks Post-training (Week 9)
Other outcomes:
Locations:
city: Chicago
country: United States
facility: University of Illinois at Chicago
state: Illinois
Study officials:
affiliation: University of Illinois at Chicago
name: Tanvi S Bhatt, PhD
role: PRINCIPAL_INVESTIGATOR
References: