CogXergaming to Promote Physical Activity and Cognitive Function in Frail Older Adults

Study Overview
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Brief Summary
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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
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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.

Official Title
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CogXergaming to Promote Physical Activity and Cognitive Function to Enhance Community Mobility and Quality of Life in Frail Older Adults

Conditions
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Frail Older Adults

Intervention / Treatment
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* Behavioral: CogXergaming
* Behavioral: Matter of Balance Training


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Older adults aged 60 years or above Walking speed <0.8m/s Self-reported Physical activity <3 hours/week Hand grip strength <30 kgs for men & <20 kgs for women Not on any sedative drugs Can understand & communicate in English Ability to walk more than 30 feet with or without an assistive device Exclusion Criteria: 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%. Unable to stand for 5 minutes without an assistive device (length of a Wii Fit game) Uncontrolled acute medical/surgical, neurological or cardiovascular disease History of bone fracture or significant other systemic disease or surgery in the last six months Moderate to severe cognitive impairment (MOCA <24/30) 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)

Ages Eligible for Study
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Minimum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: CogXergaming<br>CogXergaming based cognitive-motor balance training will be delivered to group A using the commercially available Wii-Fit Nintendo and a mouse in conjunction with cognitive training. All participants will undergo 18 sessions of training in a tapering manner for six weeks with 60-90 minutes of training per session, i.e., 3 sessions each week till the 6th week. Each session will be divided into 3 sub-sessions, where each sub-session will consist of playing 4 to 6 games in conjunction with cognitive task. All the games will be performed using a Wii-Fit balance board in front of a TV screen. | Behavioral: CogXergaming<br>* The participant will play four of the six balance board games Table tilt, Tightrope, Soccer, Balance bubble, Light Run and Basic Step (each game is max 1.5 minutes). Each game will be superimposed with any 3 of the 6 cognitive tasks (word list generation consisting of verbal fluency (VF) and category fluency (CF), digit recall (DR), analogies (AN), mental arithmetic (MA), repeated letter (RL). The cognitive tasks will be randomized making sure that all the cognitive tasks are played with all the games. The cognitive and balance board game scores will be noted on the scoring sheet for each session. A total 10 minutes rest interval between every sub-session will be mandatorily provided.<br>* Other names: Cognitive training;|
| Experimental: Matter of Balance Training<br>Participants in group B will undergo matter of balance training for 8 weeks (one session a week for 2 hours/day). | Behavioral: Matter of Balance Training<br>* The program emphasizes practical coping strategies that include group discussions, mutual problem solving, exercises to improve strength, coordination and balance, and, a home safety evaluation.<br>* Other names: Conventional training;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Movement velocity | It is the average speed of center of gravity movement during intentional movement measured in degrees per second under single and dual-task conditions. Higher values indicate better performance. | Baseline (Week 0) and Immediate Post-training (Week 8 for group A and week 10 for group B) | 
| Change in end point excursion | It is the magnitude of a self-initiated movement (i.e., how far he/she wills to reach a target) without taking a step or losing balance measured in percentage under single and dual-task conditions. Higher values indicate better performance. | Baseline (Week 0) and Immediate Post-training (Week 8 for group A and week 10 for group B) | 
| Change in maximum excursion | It is the actual magnitude of a self-initiated movement (i.e., how far did he/she actually reach a target) without taking a step or losing balance measured in percentage under single and dual-task conditions. Higher values indicate better performance. | Baseline (Week 0) and Immediate Post-training (Week 8 for group A and week 10 for group B) | 
| Change in directional control | It is the quality of a self-initiated movement (i.e., amount of movement actually exhibited towards the target to the amount of extraneous movement away from the target) measured in percentage under single and dual-task conditions. Higher values indicate better performance. | Baseline (Week 0) and Immediate Post-training (Week 8 for group A and week 10 for group B) | 
| Change in postural stability during reactive balance control (single and dual-task) | Reactive balance control will be examined via the stance perturbation test under single and dual-task conditions (simultaneous performance of Letter number sequencing task or auditory stroop task). Postural stability can be defined as simultaneous control of center of mass (COM) position and velocity during slip-like or trip like perturbation relative to the rear edge of base of support (rear heel). The position is normalized with the individual's foot length, and velocity by square root of gravitational acceleration and individual's body height. Larger values indicate greater stability. | Baseline (Week 0) and Immediate Post-training (Week 8 for group A and week 10 for group B) | 
| Change in 4 meter walk test | The total time taken to complete the 4 meters will be noted. Speed will then be determined by using the formula distance (4 meters) covered by time taken to complete the test. Higher speed indicates better performance. | Baseline (Week 0) and Immediate Post-training (Week 8 for group A and week 10 for group B) | 
| Change in spatial and temporal gait parameters | Spatial and temporal gait parameters like step length, cadence and stride length will be determined during single and dual-task walking performance via the GaitRite mat. Higher values for step length and stride length, and lower cadence indicates better performance. | Baseline (Week 0) and Immediate Post-training (Week 8 for group A and week 10 for group B) | 
| Change of accuracy in letter number sequencing | This is an oral trail making test which includes listing alternate letter and number from the cue given in sequence. This test will be performed under single and dual-task conditions. Accuracy (number of correct responses out of the total responses) of letter number sequencing will be calculated. Higher accuracy indicates better performance. | Baseline (Week 0) and Immediate Post-training (Week 8 for group A and week 10 for group B) | 
| Change in accuracy of Auditory stroop | This test involves responding to the pitch (high or low) of the words High or Low. This test will be performed under single and dual-task conditions. Accuracy (number of correct responses out of the total responses) of Auditory stroop will be calculated. Higher accuracy indicates better performance. Higher values indicate better performance. | Baseline (Week 0) and Immediate Post-training (Week 8 for group A and week 10 for group B) | 
| Change in dual-task cost | Dual-task motor and cognitive cost will be calculated using the formula- [(Dual-task performance- Single Task performance)/Single task performance]. This will be calculated for dual-task performance during intentional postural sway, reactive balance control and gait conditions. Lower cost indicates better performance. | Baseline (Week 0) and Immediate Post-training (Week 8 for group A and week 10 for group B) | 
| Change in Interference in the reaction time | Interference in the reaction time via visual stroop task where the individual is expected to respond to the color in which the word is printed and not read the word. Performance will be identified via time taken to complete the test. Lower time indicates better performance. | Baseline (Week 0) and Immediate Post-training (Week 8 for group A and week 10 for group B) | 
| Change in language fluency | Language fluency via verbal and category task will be administered. Performance will be identified via the total number of appropriate words responded on each of the task. Higher values indicate better performance. | Baseline (Week 0) and Immediate Post-training (Week 8 for group A and week 10 for group B) | 
| Change in reaction time | The individual is asked to hit a key on the number keypad when a cue appears on the screen. Performance will be identified with time taken to hit the key after the individual sees the cue in seconds. Lower time indicates better performance. | Baseline (Week 0) and Immediate Post-training (Week 8 for group A and week 10 for group B) | 
| Change in paired associated learning | Paired associated learning via grid task will be administered. Accuracy (number of correct responses out of the total responses) will be represented in percentage. Higher value indicates better performance. | Baseline (Week 0) and Immediate Post-training (Week 8 for group A and week 10 for group B) | 
| Change in spatial working memory | Spatial working memory via unveil the star task will be administered. Performance will be identified via the total time (in seconds) to complete the task. Lower time indicates better performance. | Baseline (Week 0) and Immediate Post-training (Week 8 for group A and week 10 for group B) | 
| Change in working memory | List Sorting Memory test to evaluate working memory. This test requires the participant to recall and sequentially list the visually and orally presented stimuli. The accuracy of the participant's response is computer generated. Higher value indicates better performance. | Baseline (Week 0) and Immediate Post-training (Week 8 for group A and week 10 for group B) | 
| Change in episodic memory | Picture sequence memory test will assess episodic memory of the individual. The number of adjacent pairs of pictures placed correctly will score a point. The scores are computer generated. Higher value indicates better performance. | Baseline (Week 0) and Immediate Post-training (Week 8 for group A and week 10 for group B) | 
| Change in accuracy of flanker inhibitory control and attention test | Flanker inhibitory control and attention test is used to evaluate the participant's ability to inhibit the attention to the stimulus flanking it and focus on a particular stimulus. Accuracy of the responses are recorded and the scores are computer generated. Higher value indicates better performance. | Baseline (Week 0) and Immediate Post-training (Week 8 for group A and week 10 for group B) | 
| Change in cognitive flexibility and attention | Dimensional Change card sort assesses cognitive flexibility and attention. Participants are asked to match a series of bivalent pictures either by colors or shapes accordingly. Responses are computer recorded and accuracy scores are computer generated. Higher value indicates better performance. | Baseline (Week 0) and Immediate Post-training (Week 8 for group A and week 10 for group B) | 
| Change in processing speed | Pattern comparison processing speed test is used to evaluate the processing speed. The participants are expected to respond whether the two pictures side-by side are same or not the same. Accuracy will be recorded by the computer and scores are computer generated. Higher value indicates better performance. | Baseline (Week 0) and Immediate Post-training (Week 8 for group A and week 10 for group B) | 
| Changes in fractional anisotropy | Image acquisition will be performed in a 3T and 1.5T Magnetic resonance scanner (MR 750, GE healthcare, Milwaukee). Fractional anisotropy (FA) is a scalar value ranging from 0-1 and change from pre- to post-training will compared to determine the structural and functional connectivity. Increase in FA values post-training will indicate positive results of training. | Baseline (Week 0) and Immediate Post-training (Week 8 for group A and week 10 for group B) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Berg Balance scale | Assess static and dynamic balance. This scale consists of the participant transferring from one chair to another, reaching forward, stepping up and down from a stepping stool, standing with eyes closed and open, one leg standing. It is a 14-item scale with each item score ranging from 0-4. Performance on the scale will be calculated on a total of 56. Less than 45 will indicate greater risk of falling. | Baseline (Week 0) and Immediate Post-training (Week 8 for group A and week 10 for group B) | 
| Change in physical activity level (Questionnaires) | Questionnaires such as Physical Activity Scale for elderly and activity specific balance confidence scale will be self-reported by the participant. Activity specific balance confidence scale consists of 16 items, and each item score ranges from 0-100. The total score with 0 confidence indicates no confidence and 100 with complete confidence. | Baseline (Week 0) and Immediate Post-training (Week 8 for group A and week 10 for group B) | 
| Change in physical activity level | Average number of steps taken a day by the individual prior to and after training. | Baseline (Week 0) and Immediate Post-training (Week 8 for group A and week 10 for group B) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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CogXergaming, Dual-task training, Cognitive-motor-balance training