Improving Physical Activity With Cognitive Impairment
1 other identifier
interventional
60
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Feb 2023
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 15, 2022
CompletedFirst Posted
Study publicly available on registry
May 11, 2022
CompletedStudy Start
First participant enrolled
February 1, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2025
CompletedJuly 16, 2024
July 1, 2024
2.3 years
March 15, 2022
July 15, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (5)
TPAB intervention Participant Retention
The number of participants that complete the 12 week intervention will be calculated to determine participant retention.
The outcome will be reported at the end of the 12 week intervention.
TPAB Intervention Attendance
The number of weekly sessions attended across the 12-week intervention will be totaled to determine the TPAB Intervention Attendance.
The outcome will be reported at the end of the 12 week intervention.
TPAB Intervention Acceptability
The acceptability of the TPAB Intervention will be assessed by administering the Intrinsic Motivation Inventory Interest/Enjoyment Subscale at the conclusion of the intervention. The Intrinsic Motivation Inventory Subscale includes 7 statements that require the participant to respond on a 1-7 scale to the level they agree with the statement. The total score ranges from 7-49 with higher scores indicating greater Interest/Enjoyment.
The outcome will be reported at the end of the 12 week intervention.
TPAB Intervention Safety
The safety of the TPAB Intervention will be assessed by tracking and comparing the number of adverse events in the intervention and control group.
The outcome will be reported at the end of the 12 week intervention.
Feasibility of the TPAB Intervention (Semi-Structured Interviews)
Semi-structured interview will be conducted on the patient and caregivers that participated in the TPAB Intervention. Qualitative analysis will determine common themes in the responses.
Semi-Structured Interviews will be conducted at the end of the 12 week intervention.
Secondary Outcomes (1)
Daily step count change
Baseline and after the 12 week intervention
Study Arms (2)
Telerehabilitation physical activity behavioral (TPAB) intervention
EXPERIMENTALIndividuals 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.
Control Group
NO INTERVENTIONIndividuals in the CTL group will receive usual care and no intervention over the 12 weeks.
Interventions
The intervention includes the behavior change techniques of self-monitoring of behavior, action planning, graded tasks, restructuring the physical and social environment, problem-solving, and prompts/cues.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- limitations due to disability, illness, or pain that may affect the patient's walking safety during the study
- unstable heart conditions (e.g., unstable angina, acute pericarditis)
- uncontrolled hypertension in the last six months
- known neurological diseases
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Creighton Universitylead
- National Institutes of Health (NIH)collaborator
Study Sites (1)
Creighton University
Omaha, Nebraska, 68178, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Masking Details
- The outcomes assessors will be masked from the participant's treatment arm.
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 15, 2022
First Posted
May 11, 2022
Study Start
February 1, 2023
Primary Completion
June 1, 2025
Study Completion
June 1, 2025
Last Updated
July 16, 2024
Record last verified: 2024-07