Clinical trial NCT05370118: Improving Physical Activity With Cognitive Impairment
Official title: Improving Physical Activity With Cognitive Impairment
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Mild Cognitive Impairment
Caregiver Burnout
Keywords: physical activity
behavior change
Lead sponsor: Creighton University
Sponsor class: OTHER
Collaborators: name: National Institutes of Health (NIH)
First posted: 2022-05-11
Enrollment: 60
Sex: ALL
Minimum age (years): 50
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: This pilot clinical research study is structured as a feasibility and preliminary efficacy trial to determine if the TPAB intervention is feasible and to compare daily step improvement between the TPAB intervention group and the CTL group. The trial is designed to inform a future larger-scale efficacy trial to assess longer time points for the sustainability of intervention impact.
Primary purpose: TREATMENT

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.

Detailed description: The primary objective of this pilot study is to determine the feasibility and preliminary efficacy of a telerehabilitation physical activity behavioral (TPAB) intervention for improving habitual physical activity in individuals with amnestic mild cognitive impairment (MCI).

Amnestic MCI is considered a precursor to Alzheimer's Disease (AD), the sixth leading cause of death in the US.1 Additionally, loss of independence and cognitive function is one of the most feared aspects of aging for older adults.2,3 One way to promote independence is through physical activity. Physical inactivity is highly reported in those with MCI4 and is a modifiable risk factor for those with dementia.5,6 Therefore, strategies to combat the loss of physical independence and cognition are of high economic and quality of life priority.

Home-based physical activity behavior change methods have successfully improved physical activity in healthy older adults7-10 but have had limited use in individuals with MCI.11 This study will determine the feasibility and preliminary efficacy of the TPAB intervention in individuals with amnestic MCI and caregivers to provide the groundwork to ascertain clinical implementation. In this randomized controlled clinical research study, we will assess the feasibility and preliminary efficacy of the TPAB intervention in individuals with amnestic MCI. The TPAB intervention consists of 12 telerehabilitation sessions (30 min) over 12 weeks. Primary caregivers will be included during all intervention sessions based on dyadic approaches demonstrating higher physical activity invention success in individuals with MCI compared to individual recruitment.12 The TPAB intervention group will include 15 dyads of patients with amnestic MCI and their primary caregivers. The TPAB intervention is an evidence-based intervention designed to improve daily steps in older adults with medical complexities.13-15 It combines strategies such as problem-solving11, action planning16, and motivational interviewing17 that are evidenced to improve physical activity in individuals with MCI.11,16,17 The TPAB intervention will require a wearable sensor (Fitbit) and a home-based tablet/laptop to allow real-time activity feedback and video interface between participants and the interventionist. The TPAB intervention is novel in combining theories and techniques and remote delivery for individuals with amnestic MCI. The control (CTL) group will include 15 dyads of individuals with amnestic MCI and their primary caregivers that will receive usual care over the 12 weeks. Outcomes for both groups will be assessed before the intervention (baseline) and at the end of the intervention (POST). The specific aims are:

Aim 1: Determine the feasibility of the TPAB intervention for individuals with amnestic MCI and their primary caregivers by measuring 1) participant retention, 2) attendance, 3) acceptability (Intrinsic Motivation Inventory18), 3) safety (adverse event tracking), 4) semi-structured interviews.

Aim 2: Examine the preliminary effects of TPAB on physical activity engagement among MCI participants when compared with the CTL group.

Hypothesis 2.1: Individuals with amnestic MCI will make significant (p\<0.05) gains in accelerometer-assessed (activPAL) physical activity (daily steps) from baseline to POST compared to the CTL group.

Clinical Impact: This study addresses two significant clinical gaps for amnestic MCI rehabilitation: 1) lack of evidence-based rehabilitation strategies to improve habitual physical activity; and 2) barriers to remotely promote habitual physical activity. Lastly, this project will bring together an interdisciplinary team (physical therapist (RH), exercise scientist (DE), and neuropsychologist (VP)) of investigators at Creighton University and the University of Nebraska Medical Center (UNMC).

Eligibility criteria: Inclusion Criteria:

1. 50-85 years old (patient); 19+ years (caregiver)
2. clinically diagnosed with amnestic MCI (patient only)
3. a score of 18-24 on the Montreal Cognitive Assessment indicating possible MCI (patient only),
4. not currently categorized as "Active" on the Rapid Assessment of Physical Activity, (patient only)
5. on stable doses of medication at least for the previous 30 days at baseline (patient only)
6. have a computer/wireless device with Internet access
7. have a primary caregiver willing to participate in physical activity and assist the patient with participation in the study
8. English-speaking

Exclusion Criteria:

1. limitations due to disability, illness, or pain that may affect the patient's walking safety during the study
2. unstable heart conditions (e.g., unstable angina, acute pericarditis)
3. uncontrolled hypertension in the last six months
4. known neurological diseases

Primary outcomes:
measure: TPAB intervention Participant Retention
timeFrame: The outcome will be reported at the end of the 12 week intervention.
measure: TPAB Intervention Attendance
timeFrame: The outcome will be reported at the end of the 12 week intervention.
measure: TPAB Intervention Acceptability
timeFrame: The outcome will be reported at the end of the 12 week intervention.
measure: TPAB Intervention Safety
timeFrame: The outcome will be reported at the end of the 12 week intervention.
measure: Feasibility of the TPAB Intervention (Semi-Structured Interviews)
timeFrame: Semi-Structured Interviews will be conducted at the end of the 12 week intervention.
Secondary outcomes:
measure: Daily step count change
timeFrame: Baseline and after the 12 week intervention
Other outcomes:
Locations:
city: Omaha
country: United States
facility: Creighton University
state: Nebraska
Study officials:
References: