Clinical trial NCT04160299: Effectiveness of Alternative Therapy for Improving Cognition, Balance, and Physical Activity
Official title: Effectiveness of Alternative Therapy for Improving Cognition, Balance, and Physical Activity in Older Adults With Mild Cognitive Deficits for Home or Community-based Translation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Mild Cognitive Impairment
Older Adults
Neurological Injury
Lead sponsor: University of Illinois at Chicago
Sponsor class: OTHER
Collaborators: name: National Institute on Aging (NIA)
First posted: 2019-11-13
Enrollment: 21
Sex: ALL
Minimum age (years): 65
Maximum age (years): 90
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Older adults with Mild Cognitive Impairments, MCI.
Primary purpose: OTHER

Brief summary: The composite effect of reduced balance, cognition, gait abnormalities/gait disturbances, and physical activity in older adults with mild cognitive impairments (MCI) leads to fear of falling and reduced participation in daily activities, which results in reduced cardiovascular fitness and deconditioning. Although many conventional balance and strength training programs have been implemented for older adults with MCI; these adults do not receive adequate practice dosage to make significant improvements, most likely due to lack of adherence to therapy and/or inadequate incorporation of all domains of the ICF model (body functions and structures, activities and participation) and lack of targeting cognitive-motor interference (deterioration of motor and/or cognitive function when both tasks are performed together). The use of alternative therapies such as dance and virtual reality (VR) has been found to be relatively enjoyable for older adults due to increased motivation, which led to the added improvement of physical and cognitive functioning. The overall aims of this pilot is to test the feasibility of VR-based dance therapy paradigm for older adults with MCI as well as its effect on enhancing balance, gait, and cognition, and physical fitness. Investigators also hope that the net effect of improvement in these domains of health outcomes will result in pre and post reduction of fall risk and improved quality of life of older adults with MCI.

The study investigates the effectiveness of a VR (Kinect)-based dance therapy in older adults with MCI by demonstrating its feasibility and compliance rate and also determine the efficacy of the VR-based dance therapy in improving health outcomes such as motor and cognitive functions, thereby reducing cognitive-motor interference. The study will also aim to determine the effectiveness of the VR-based dance paradigm in improving cardiovascular fitness and physical activity (PA) in older adults with MCI

Detailed description: Aging results in neuromuscular deterioration, such as impaired balance control, gait instability, and worsening cognition, with increasing evidence pointing to the over-reliance on cognitive function to perform even simple motor tasks. Such deterioration has been shown to affect daily functional activities, quality of life, and cardiovascular fitness, along with an increase in the risk of falling. Recent literature has indicated that individuals with mild cognitive impairment (MCI) exhibit reduced gait speed during dual-tasking (DT) (performing a motor and cognitive task concurrently), thereby increasing the risk of falls. Physical activity has been recommended as a means to slow down neuromuscular deterioration and enhance gait, stability, and cognition in older adults with MCI. Further, increased levels of physical activity have also demonstrated positive effects on cardiovascular fitness (heart rate variability, HRV). However, older adults with MCI do not meet the recommended daily requirement (of at least 5000 steps/day) due to reduced motivation and lack of compliance to physical activity regimen. The lack of compliance may emanate from reduced levels of multisensory feedback, lack of involvement, and the decreased participatory nature of most conventional physical therapy interventions. As a result, there is the need to implement an alternative intervention for older adults with MCI. This alternative therapy should be motivational and enjoyable with increased participation or involvement, while providing increased sensorimotor feedback, and aiming to improve cognition, physical activity and balance for fall prevention in older adults. Dance therapy, as an alternative therapy, has shown to increase both physical and cognitive function as well as increase motivation among older adults. A preliminary study conducted with virtual reality (VR)-based dance, showed the integration of virtual reality and dance to be feasible in improving physical function and balance in people with stroke. It is postulated that people with MCI could benefit from an integrated VR-based dance therapy. However, there is no data on the feasibility and effect of VR-based dance therapy on compliance, cognitive, gait and physical activity measures among adults with MCI. Investigators, therefore, seek to examine the feasibility of alternative VR-based dance therapy through the use of commercially available and cost-effective Kinect systems in the laboratory setting. The reduced feasibility and lack of compliance associated with various forms of conventional therapy in MCI adults, due to reduced motivation, have been well documented. Dance, as an alternative therapy has been found to be more enjoyable while providing increased motivation for older adults, due to its effects on motivational brain centers of the nervous system. Dance stimulates interacting active brain centers that help in motor control, ambulation, and cognitive functions. Few studies have indicated that dance- based training activates Action Observation Network system (AON) and other brain centers, which is known to improve balance control through increased plasticity of neural systems (mirror neurons) for optimal observation and actual performance of dance. Impairment in cognitive function is depicted as slow gait during dual-task conditions. Slow gait dual tasking is relevant predictor of falls in older adults with MCI.

3.0 Objectives/Aims

Aim 1: To demonstrate feasibility and compliance rate of a VR-based dance training paradigm for community-based older adults with mild-cognitive impairment (CB-MCI). Hypothesis 1: At post-training, results will demonstrate feasibility of a VR-based dance therapy, which will be evaluated through both structured patient interviews and structured questionnaires \[ITC-Sense of Presence Inventory questionnaire\]. Participants will also demonstrate appropriate compliance (attend \>24/30 session) and motivation (\>Intrinsic Motivation Inventory scores) post-intervention.

Aim 2: To determine the effectiveness of VR-based dance training paradigm in improving motor and cognitive functions, by reducing cognitive-motor interference.

Hypothesis 2: When post-training tests are compared to those of pre-training, there will be a significant improvement in balance (on limits of stability test) and gait (in spatiotemporal parameters), motor and cognition (assessed by a neuropsychological test battery), which will result in overall reduced cognitive-motor interference (dual-task cost during balance and gait tasks).

Aim 3: To determine the effect of a VR-based dance training paradigm on improving cardiovascular (heart rate variability HRV) and physical fitness (physical activity, PA) of community-based older adults with MCI.

Hypothesis 3: Post-training measures will depict a significant improvement in cardiovascular and physical activity fitness.

Ancillary hypothesis (Aims 1-3): To determine if improved cognitive-motor function and physical fitness gained from a VR-based dance intervention will translate into improved fall efficacy and quality of life post withdrawal of intervention. Hypothesis: At 14 weeks (4 weeks post-intervention or withdrawal), participants will have retention of the post-training gains in cognitive-motor function and cardiovascular fitness, which will translate into improved falls efficacy (improvement on Activities-specific Balance Confidence scale), quality of life (Older People's Quality of Life Questionnaire (OPQOL-35) and participation (improved Community Integration Scale) compared to their pre-training.

Participants with MCI (≥ 65 years) will receive VR-based dance training for 10-weeks (30 sessions total) using the commercially available Kinect dance video game "Just Dance 3". Ten weeks of VR-based dance therapy falls within the normal duration for most dance and other alternative therapy studies provided for older adults. If successful, such intervention could then be implemented in the home or community setting and can then be delivered by caregivers either in an independent or assisted living facility after the caregivers receive training from the rehabilitation therapists.

Eligibility criteria: Inclusion Criteria:

* Age group: ≥65 years
* Montreal cognitive Assessment (MOCA) score \<26/30
* Bone density with a t-score ≥ -2
* Absence of any acute or chronic neurological, cardiopulmonary, musculoskeletal, or systemic diagnosis.
* No recent major surgery (\< 6 months)
* No recent hospitalization (\< 3 months)
* Not on any sedative drugs
* Can understand and communicate in English

Exclusion Criteria:

* HR \> 85% of age-predicted maximal heart rate (HRmax = 220 - age)
* Systolic blood pressure (SBP) \> 165 mmHg and/or diastolic blood pressure (DBP) \> 110 mmHg during resting
* Oxygen saturation (measured by pulse oximeter) during resting \< 95%
* Inability to stand for at least 5 minutes without an assistive device (length of dance game)
* History of bone fracture or significant other systemic disease or surgery in the last six months

Primary outcomes:
measure: Feasibility of a 10-week Virtual reality-based dance training: questionnaire
timeFrame: Week 10
measure: Compliance rate of participants to a 10-week virtual reality-based dance training
timeFrame: End of all dance training sessions at Week 10
measure: Change in cognitive functions during single and dual tasks
timeFrame: Baseline at Week 0, Mid-intervention at week 5, post-intervention week 11 and Follow-up at week 14
measure: Change in incidence of falls
timeFrame: Baseline at week 0 and Follow-up at week 14
measure: Change in end point excursion
timeFrame: Baseline at week 0, mid-intervention at week 5, post-intervention at week 11 and follow-up test at week 14
measure: Change in Movement velocity
timeFrame: Baseline at week 0, mid-intervention at week 5, post-intervention at week 11 and follow-up test at week 14
measure: Change in maximum excursion
timeFrame: Baseline at week 0, mid-intervention at week 5, post-intervention at week 11 and follow-up test at week 14
measure: Change in directional control
timeFrame: Baseline at week 0, mid-intervention at week 5, post-intervention at week 11 and follow-up test at week 14
measure: Change in postural stability during reactive balance control (single and dual-task)
timeFrame: Baseline at week 0, mid-intervention at week 5, post-intervention at week 11 and follow-up test at week 14
measure: Change in step length
timeFrame: Baseline at week 0, mid-intervention at week 5, post-intervention at week 11 and follow-up test at week 14
measure: Change in gait speed
timeFrame: Baseline at week 0, mid-intervention at week 5, post-intervention at week 11 and follow-up test at week 14
measure: Change in cadence
timeFrame: Baseline at week 0, mid-intervention at week 5, post-intervention at week 11 and follow-up test at week 14
Secondary outcomes:
measure: Change in Blood pressure (mmHg)
timeFrame: Baseline at week 0, mid-intervention at week 5, post-intervention at week 11 and follow-up test at week 14
measure: Change in heart rate (beats per minute, bpm)
timeFrame: Baseline at week 0, mid-intervention at week 5, post-intervention at week 11 and follow-up test at week 14
measure: Change in physical activity level (step count)
timeFrame: Baseline at week 0, mid-intervention at week 5, post-intervention at week 11 and follow-up test at week 14
measure: Change in distance covered in Six-minute walk test (6MWT)
timeFrame: Baseline at week 0, mid-intervention at week 5, post-intervention at week 11 and follow-up test at week 14
measure: Change in time taken to complete Timed-Up and Go (TUG)
timeFrame: Baseline at week 0, mid-intervention at week 5, post-intervention at week 11 and follow-up test at week 14
measure: Berg Balance scale
timeFrame: Baseline at week 0, mid-intervention at week 5, post-intervention at week 11 and follow-up test at week 14
measure: Change in fall incidence in the home and community setting
timeFrame: Follow-up test at week 14
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 Bhatt, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Illinois at Chicago
name: Ernest K Ofori, MS
role: PRINCIPAL_INVESTIGATOR
References: