Clinical trial NCT04534686: CogXergaming to Promote Physical Activity and Cognitive Function in Frail Older Adults
Official title: CogXergaming to Promote Physical Activity and Cognitive Function to Enhance Community Mobility and Quality of Life in Frail Older Adults
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Frail Older Adults
Keywords: CogXergaming
Dual-task training
Cognitive-motor-balance training
Lead sponsor: University of Illinois at Chicago
Sponsor class: OTHER
First posted: 2020-09-01
Enrollment: 50
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Due to the age associated sarcopenia and reduced cardiovascular fitness, frail older adults experience significant decrease in physical function which comprises of mobility, endurance, muscle strength and balance control. The impaired physical function results in poor quality of life and reduced community participation, leading to increased frailty and long-term disability. Further, compared to cognitively intact frail older adults, cognitively impaired frail older adults experience greater deterioration of such physical function, specifically during dual-task performances (i.e., simultaneous performance of cognitive and motor task). This deterioration occurs due to increased cognitive-motor interference as a result of dual-tasking and is known to increase exhaustion among frail older adults. Previous studies have used multicomponent training and have shown to improve physical function and maintain cardiovascular functioning. However, the capacity of such interventions to improve cognitive function along with physical function is not known or unclear. Further, the concurrent comorbidities that occur along with psychosocial issues such as depression present as barriers and lead to reduced compliance to therapy leaving only a few of them to benefit from it. Alternate forms of therapy such as exergaming with explicit cognitive training has shown promising effects in improving motor and motor function in disabled populations. These studies use a cost-effective, off the shelf device such as Nintendo Wii or Microsoft Kinect to deliver the training which is easily available and clinically translatable. Further, such training has demonstrated increase in brain connectivity enhancing cognitive functions associated with balance control. However, there is limited literature examining the effect of exergaming in older frail population and the efficacy of such training is unknown. Therefore, this study proposes a randomized controlled trial to examine the feasibility of CogXergaming program with an aim to improve locomotor-balance control, cognition, muscular system and cardiovascular fitness.

Detailed description: The population of adults aged 60 years and older has been growing with around half of the people older than 85 years estimated to be frail. Age-related changes in multiple systems affecting balance, mobility, muscle strength, motor processing, cognition, nutrition, endurance and physical activity (PA) results in frailty. Studies on frail older adults have reported improvement in mobility and functional level following exercise interventions. Regular physical activity in this population has helped improve cardiovascular conditioning and quality of life, thus allowing these frail older adults a chance at independent living in the community. In addition to physical comorbidities, the presence of psychosocial issues such as depression may act as a barrier to community participation. Several PA interventions have demonstrated limited long-term effect and sustainable behavioral change in this population. An evidence-based fall prevention program called Matter of Balance (MOB) was developed to reduce fall risk and improve physical function and maximize activity participation in older adults. Meanwhile, Exergaming, a task-specific interactive gaming, has been gaining attention as a novel therapeutic alternative that promotes motor recovery in healthy and disabled populations. Exergaming involves repetitive-task specific exercises with movement execution feedback and motivation provided in real time. Studies have shown Exergaming improved symmetrical weight shifting, multi-directional stepping, single-stance, rapid movement training and self-initiated postural weight shifts in the participants. This anticipatory postural control training helps significantly improve balance control and mobility. In addition to the physical function domains that underlie physical frailty, executive cognitive domain functions also predict late-life physiological impairments. Thus, we postulate that PA facilitated through Exergaming and accompanied by simultaneous cognitive training is a novel approach to counter and inhibit frailty associated with physical function and cognitive decline.

Aim 1: To test the feasibility (compliance and effectiveness) of cognitive-motor exergaming (CogXergaming) in the frail older adults and to compare the improvements in behavioral biomarkers in this group across balance, muscle fitness, cardiovascular fitness and global cognition to the group receiving the Matter of Balance training.

Hypothesis: Participants will respond well to CogXergaming training paradigm and demonstrate significant improvements in balance, muscular fitness, cardiovascular fitness and global cognition as compared to the Matter of Balance training group.

Aim 2: To examine the effect of CogXergaming on physical activity levels and quality of life measures post-intervention.

Hypothesis: The participants who received CogXergaming will demonstrate significant improvement in physical activity and quality of life post-training as compared to their own pre-training scores.

Aim 3: To examine the effect of CogXergaming structural and functional connectivity within the cognitive-motor areas pre and post training to establish effect size.

Hypothesis: Post-training, participants will demonstrate improved memory consolidation, attention, motor planning and execution compared to pre-training indicating improved functional connectivity within the cognitive-motor areas.

Eligibility criteria: Inclusion Criteria:

1. Older adults aged 60 years or above
2. Walking speed \<0.8m/s
3. Self-reported Physical activity \<3 hours/week
4. Hand grip strength \<30 kgs for men \& \<20 kgs for women
5. Not on any sedative drugs
6. Can understand \& communicate in English
7. Ability to walk more than 30 feet with or without an assistive device

Exclusion Criteria:

1. Participants will not proceed with the study if any of the following occurs at baseline measurement: 1) HR \> 85% of age-predicted maximal heart rate (HRmax) (HRmax = 220 - age), 2) systolic blood pressure (SBP) \> 165 mmHg and/or diastolic blood pressure (DBP) \> 110 mmHg during resting), and/or 3) oxygen saturation (measured by pulse oximeter) during resting \< 90%.
2. Unable to stand for 5 minutes without an assistive device (length of a Wii Fit game)
3. Uncontrolled acute medical/surgical, neurological or cardiovascular disease
4. History of bone fracture or significant other systemic disease or surgery in the last six months
5. Moderate to severe cognitive impairment (MOCA \<24/30)
6. Specific to MRI participants: Self-reported presence of pacemaker, metal implants other than orthopedic implants, and/or Claustrophobia, cataract surgery (lens not compatible to the MRI confirmed by the MRI technician)

Primary outcomes:
measure: Change in Movement velocity
timeFrame: Baseline (Week 0) and Immediate Post-training (Week 8 for group A and week 10 for group B)
measure: Change in end point excursion
timeFrame: Baseline (Week 0) and Immediate Post-training (Week 8 for group A and week 10 for group B)
measure: Change in maximum excursion
timeFrame: Baseline (Week 0) and Immediate Post-training (Week 8 for group A and week 10 for group B)
measure: Change in directional control
timeFrame: Baseline (Week 0) and Immediate Post-training (Week 8 for group A and week 10 for group B)
measure: Change in postural stability during reactive balance control (single and dual-task)
timeFrame: Baseline (Week 0) and Immediate Post-training (Week 8 for group A and week 10 for group B)
measure: Change in 4 meter walk test
timeFrame: Baseline (Week 0) and Immediate Post-training (Week 8 for group A and week 10 for group B)
measure: Change in spatial and temporal gait parameters
timeFrame: Baseline (Week 0) and Immediate Post-training (Week 8 for group A and week 10 for group B)
measure: Change of accuracy in letter number sequencing
timeFrame: Baseline (Week 0) and Immediate Post-training (Week 8 for group A and week 10 for group B)
measure: Change in accuracy of Auditory stroop
timeFrame: Baseline (Week 0) and Immediate Post-training (Week 8 for group A and week 10 for group B)
measure: Change in dual-task cost
timeFrame: Baseline (Week 0) and Immediate Post-training (Week 8 for group A and week 10 for group B)
measure: Change in Interference in the reaction time
timeFrame: Baseline (Week 0) and Immediate Post-training (Week 8 for group A and week 10 for group B)
measure: Change in language fluency
timeFrame: Baseline (Week 0) and Immediate Post-training (Week 8 for group A and week 10 for group B)
measure: Change in reaction time
timeFrame: Baseline (Week 0) and Immediate Post-training (Week 8 for group A and week 10 for group B)
measure: Change in paired associated learning
timeFrame: Baseline (Week 0) and Immediate Post-training (Week 8 for group A and week 10 for group B)
measure: Change in spatial working memory
timeFrame: Baseline (Week 0) and Immediate Post-training (Week 8 for group A and week 10 for group B)
measure: Change in working memory
timeFrame: Baseline (Week 0) and Immediate Post-training (Week 8 for group A and week 10 for group B)
measure: Change in episodic memory
timeFrame: Baseline (Week 0) and Immediate Post-training (Week 8 for group A and week 10 for group B)
measure: Change in accuracy of flanker inhibitory control and attention test
timeFrame: Baseline (Week 0) and Immediate Post-training (Week 8 for group A and week 10 for group B)
measure: Change in cognitive flexibility and attention
timeFrame: Baseline (Week 0) and Immediate Post-training (Week 8 for group A and week 10 for group B)
measure: Change in processing speed
timeFrame: Baseline (Week 0) and Immediate Post-training (Week 8 for group A and week 10 for group B)
measure: Changes in fractional anisotropy
timeFrame: Baseline (Week 0) and Immediate Post-training (Week 8 for group A and week 10 for group B)
Secondary outcomes:
measure: Berg Balance scale
timeFrame: Baseline (Week 0) and Immediate Post-training (Week 8 for group A and week 10 for group B)
measure: Change in physical activity level (Questionnaires)
timeFrame: Baseline (Week 0) and Immediate Post-training (Week 8 for group A and week 10 for group B)
measure: Change in physical activity level
timeFrame: Baseline (Week 0) and Immediate Post-training (Week 8 for group A and week 10 for group B)
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, PT,MS,PhD
role: PRINCIPAL_INVESTIGATOR
References: