Clinical trial NCT06799429: Brain Health Fitness Program: Exercise for People with Mild-moderate Cognitive Impairments
Official title: Implementing Brain Health Fitness: an On-going Individual Coaching and Exercise Intervention for People Living with Mild-moderate Cognitive Impairments in South Carolina
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Cognitive Impairment
Keywords: cognitive impairment
exercise
Lead sponsor: University of South Carolina
Sponsor class: OTHER
Collaborators: name: Foundation of Physical Therapy Research
First posted: 2025-01-29
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: The goal of this clinical trial is to test a 6-month, twice a week, moderate intensity exercise and coaching program (an in-person group and a distance group) for adults with mild-moderate cognitive impairments living in South Carolina. The main questions it aims to answer are:

1. Is the program practical to conduct, and it is acceptable and enjoyable? The hypothesis is that it will be possible to recruit participants, obtain the desired dosage of moderate intensity fitness and strength training twice a week.
2. Are their changes at 3-months and 6-months in endurance, mobility, cognitive function and perception of cognitive function? The hypotheses are that endurance, strength and mobility will improve and cognitive measures will not decline (remain the same or improve).

Participants will exercise twice a week in-person with a coach or at a distance location with coaching support for six months.

Detailed description: In person Exercise Group:

The exercise program interventions will be individualized based on exercise history, and initial assessments by the primary investigator (a physical therapist). The program will focus on building up to 30 minutes of moderate intensity endurance activity and up to 30 minutes of strength training, balance training and mobility training. Participants will attend times per week for six months. Coaches will provide exercise plans, and monitor and provide feedback as participants exercise. Participants will wear a heart rate monitor to record exertion. Participants will be able to continuously attend as long as they are attending regularly.

Distance Exercise Group:

The exercise program interventions will be individualized based on exercise history, and initial assessments by the primary investigator (a physical therapist) which will occur in person. The program will focus on building up to 30 minutes of moderate intensity endurance activity and up to 30 minutes of strength training, balance training and mobility training. Participants will exercise on their own 2 x a week for 6 months.Coaches will prescribe an exercise program that can be performed at a local fitness facility or at home and it will be shared through a coaching software. Participants will log their exercises either in the coaching software or in paper formats, have weekly check-ins with fitness center coaches and have options to message the fitness center coaches with questions. Participants who do not log any activity and miss weekly check-ins will have follow up from fitness center coaches.

Eligibility criteria: Inclusion Criteria:

* medical diagnosis of mild-moderate cognitive impairment
* medically cleared for exercise
* able to follow 2-step commands Exclusion criteria are significant pain with movement (\>5/10)

Exclusion Criteria:

* significant pain with movement (\>5/10)
* severe balance impairments or lack of independence on and off exercise equipment (by physical therapist judgement).

Primary outcomes:
measure: Aim 1 Feasibility: Recruitment and Uptake through qualified referrals
timeFrame: through study completion, an average of 1 year
measure: Aim 1 Feasibility: Program Fidelity Dosage: session adherence
timeFrame: through study completion, an average of 1 year
measure: Aim 1 Feasibility: Program Fidelity Dosage: Session Duration
timeFrame: through study completion, an average of 1 year
measure: Aim 1 Feasibility: Program Fidelity: Exercise Intensity
timeFrame: through study completion, an average of 1 year
measure: Aim 1 Feasibility: Acceptability: Participant Satisfaction
timeFrame: through study completion, an average of 1 year
measure: Aim 2 Exploratory Individual Outcomes: Processing Speed and Executive Function through the Oral Symbol Digits Test (NIH Toolbox)
timeFrame: pre-program (baseline), mid-program (3 months) and post-program (6-months)
measure: Aim 2 Exploratory Individual Outcomes: Cardiovascular Endurance through the six-minute walk test
timeFrame: pre-program (baseline), mid-program (3 months) and post-program (6-months)
Secondary outcomes:
measure: Aim 2 Exploratory Individual Outcomes: Mobility and Balance through the Short Physical Performance Battery
timeFrame: pre-program (baseline), mid-program (3 months) and post-program (6-months)
measure: Aim 2 Exploratory Individual Outcomes: Grip Strength using a hand-held grip dynamometer (lbs. of force)
timeFrame: pre-program (baseline), mid-program (3 months) and post-program (6-months)
measure: Aim 2 Exploratory Individual Outcomes: Perception of cognition through the Patient-Reported Outcomes Measurement Information System (PROMIS) Computer Adaptive Testing survey
timeFrame: pre-program (baseline), mid-program (3 months) and post-program (6-months)
Other outcomes:
Locations:
city: Columbia
country: United States
facility: Arnold School of Public Health
state: South Carolina
Study officials:
References: