N/A
N=16
Improving Physical Activity With Cognitive Impairment
Mild Cognitive Impairment · Caregiver Burnout
Bottom Line
View on ClinicalTrials.gov: NCT05370118 ↗Enrolled (actual)
16
Serious AEs
6.3%
Results posted
May 2026
Primary outcome: Primary: TPAB Intervention Participant Retention — 5; 5; 3; 3 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Telerehabilitation physical activity behavioral (TPAB) intervention (Behavioral)
- Age
- Adult, Older Adult · 50+ yrs
- Sex
- All
- Sponsor
- Creighton University
- Primary completion
- Jun 2025
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY TPAB Intervention Participant Retention |
5; 5; 3; 3 | — |
| PRIMARY TPAB Intervention Attendance |
96.67; 96.67 | — |
| PRIMARY TPAB Intervention Acceptability |
6.14; 6.37 | — |
| PRIMARY TPAB Intervention Safety |
3; 0; 0; 0 | — |
| PRIMARY Feasibility of the TPAB Intervention (Semi-Structured Interviews) |
3; 4; 1; 1; 2; 4 | — |
| SECONDARY Change in Average Daily Steps |
784.60; 363.40; -1900.33; -428.00 | 0.04 sig |
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 Criteria
Inclusion Criteria
- 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
Exclusion Criteria
- 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
Data sourced from ClinicalTrials.gov (NCT05370118). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.