Improving Physical Activity With Cognitive Impairment

Status: Recruiting
Location: See location...
Intervention Type: Behavioral
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

Individuals with mild cognitive impairment are often physically inactive and at risk for progressing to dementia. Physical inactivity is considered a modifiable risk factor for dementia. Therefore, interventions must be developed to foster sustainable improvement in daily physical activity. To address this problem, our pilot study aims are directed at assessing the feasibility and preliminary improvement of physical activity following the use of a mobile-health technology physical activity behavior change intervention. Similar interventions have shown to be very effective in older adults without cognitive impairment. We specifically focus on the subtype of amnestic mild cognitive impairment since this subtype often progresses to Alzheimer's Disease, a leading cause of death in the US. Improving physical activity is one approach to reduce the progression to Alzheimer's Disease and subsequently lower mortality. To increase the impact of the intervention, participants with amnestic mild cognitive impairment will be recruited along with a primary caregiver (dyads). Thirty dyads will be recruited and randomized to either an intervention group (15 dyads) or usual care group (15 dyads). The intervention group will receive a 12-week mobile-health technology physical activity behavior change intervention structured to improve physical activity. The intervention is unique in the combination of established behavior change theories and techniques and remote delivery for individuals with amnestic mild cognitive impairment. This pilot study is designed to assess the feasibility of the intervention by examining participant and primary caregiver retention, intervention session attendance, intervention acceptability and safety, and qualitative perspectives. Secondly, this pilot study will assess preliminary improvement in physical activity (i.e., daily steps). Improvement will be determined based on significant changes in participants' daily steps observed via accelerometry post-intervention in the intervention group compared to the usual care control group. The results of this study will support future work (K-award and R01 submissions) to explore efficacy and larger-scale implementation to reach rural and underserved areas of Nebraska and beyond.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 50
Maximum Age: 85
Healthy Volunteers: t
View:

• 50-85 years old (patient); 19+ years (caregiver)

• clinically diagnosed with amnestic MCI (patient only)

• a score of 18-24 on the Montreal Cognitive Assessment indicating possible MCI (patient only),

• not currently categorized as Active on the Rapid Assessment of Physical Activity, (patient only)

• on stable doses of medication at least for the previous 30 days at baseline (patient only)

• have a computer/wireless device with Internet access

• have a primary caregiver willing to participate in physical activity and assist the patient with participation in the study

• English-speaking

Locations
United States
Nebraska
Creighton University
RECRUITING
Omaha
Contact Information
Primary
Rashelle Hoffman, PT, DPT, PhD
rashellehoffman@creighton.edu
402-280-5691
Time Frame
Start Date: 2023-02-01
Estimated Completion Date: 2025-06
Participants
Target number of participants: 60
Treatments
Experimental: Telerehabilitation physical activity behavioral (TPAB) intervention
Individuals in the TPAB intervention will participate in a weekly session for 12 weeks with their primary caregiver and the research interventionist (RH). Established behavior-change techniques will be used in the TPAB intervention, based largely on the combination of the Social Cognitive Theory, Control Theory, and Operant Conditioning,43 including behavioral techniques, and patient-centered communication (e.g., motivational interviewing).44 The behavior-change techniques are designed to target and improve daily steps. Individuals in the CTL group will receive usual care and no intervention over the 12 weeks.
No_intervention: Control Group
Individuals in the CTL group will receive usual care and no intervention over the 12 weeks.
Related Therapeutic Areas
Sponsors
Leads: Creighton University
Collaborators: National Institutes of Health (NIH)

This content was sourced from clinicaltrials.gov