NCT04938349 Dual Task Perturbation Training for OAwMCI
| NCT ID | NCT04938349 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University of Illinois at Chicago |
| Condition | Mild Cognitive Impairment |
| Study Type | INTERVENTIONAL |
| Enrollment | 142 participants |
| Start Date | 2021-09-14 |
| Primary Completion | 2027-03-31 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 142 participants in total. It began in 2021-09-14 with a primary completion date of 2027-03-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
Studies have determined that compared to cognitively intact older adults (CIOA), older adults with mild cognitive impairment (OAwMCI) exhibit more pronounced balance and gait impairments which lead to an increased risk of falls and mobility decline. Such impairments are evident during dual-tasking (i.e., simultaneous performance of cognitive and motor task) and OAwMCI have demonstrated an increased cognitive-motor interference (deteriorated performance of either or both cognitive/motor task). Furthermore, our preliminary laboratory findings indicate that compared to CIOA, OAwMCI in response to large-magnitude treadmill perturbations exhibits poor reactive responses (first line of defense against balance loss) and are unable to modulate their responses as the magnitude of perturbation increases. Despite that conventional exercise methods offer beneficial effects; they comprise of self-initiated task-specific exercises and may not focus on training reactive responses. Additionally, due to the presence of subtle balance and gait deficits, clinical measures used may not be sensitive enough to determine the risk of fall post-training. Furthermore, these training methods incorporate multiple sessions due to which adherence to exercise training is difficult with only a fraction of the older adults benefiting from it. Therefore, it is essential to incorporate a task-specific strategy that promotes factors associated with falling like balance control, muscular responses, coordination of limbs, and cognition through which OAwMCI may acquire maximum benefits to prevent a balance loss. One feasible method, which harnesses technology that can be used to deliver balance disturbances either while standing or walking in a consistent and controlled manner, is via a custom-based motorized treadmill. The scientific rigor from preliminary studies has reported a successful reduction of falls through a single session exposing CIOA to multiple treadmill-induced perturbations during gait and has shown significant improvement in reactive responses. For that reason, this stage 1 pilot study will examine the feasibility, applicability, and tolerability of a combined cognitive, and perturbation training on biomechanical determinants associated with falls and promote physical activity: kinematic variables, muscular responses, and cognitive function.
Eligibility Criteria
Inclusion Criteria: * Age group: Older adults between the age group \> 55 years old with MOCA less than 26 out of 30 will be classified as mild cognitive impairment and those above 26 out of 30 as cognitively intact older adults . * Absence of any acute or chronic neurological (Stroke, Parkinson's disease, Alzheimer's disease), cardiopulmonary, musculoskeletal, or systemic diagnosis. * No recent major surgery (\< 6 months) or hospitalization (\< 3 months) * Not on any sedative drugs * Can understand and communicate in English * Ability to walk more than 10 meters 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%. * History of bone fracture or significant other systemic disease or surgery in the last six months * Specific to MRI participants: Self-reported presence of a pacemaker, metal implants other than orthopedic implants, and/or Claustrophobia, cataract surgery (lens not compatible to the MRI confirmed by the MRI technician) * Weighs \> 220 lbs (Harness weight threshold)
Contact & Investigator
Tanvi Bhatt
PRINCIPAL INVESTIGATOR
University of Illinois at Chicago
Frequently Asked Questions
Who can join the NCT04938349 clinical trial?
This trial is open to participants of all sexes, aged 55 Years or older, studying Mild Cognitive Impairment. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT04938349 currently recruiting?
Yes, NCT04938349 is actively recruiting participants. Contact the research team at tbhatt6@uic.edu for enrollment information.
Where is the NCT04938349 trial being conducted?
This trial is being conducted at Chicago, United States.
Who is sponsoring the NCT04938349 clinical trial?
NCT04938349 is sponsored by University of Illinois at Chicago. The principal investigator is Tanvi Bhatt at University of Illinois at Chicago. The trial plans to enroll 142 participants.