Brain Health Fitness Program: Exercise for People with Mild-moderate Cognitive Impairments

NCT ID: NCT06799429

Last Updated: 2025-01-29

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-11-01
• Study Completion Date: 2025-12-31

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.

Conditions

Cognitive Impairment

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

Supervised In-Person Group

For the in-person exercise group, exercise activity will be in the twice weekly in-person supervised, directed sessions at the Train Your Brain Fitness Center at the Arnold School of Public Health in Columbia, South Carolina. The exercise intervention will have a goal of up to120 minutes (60 minutes 2 x a week) of moderate intensity exercise, building up to that amount based on ability. This will include 45-60 minutes per week of cardiovascular activity (walking/jogging outside or on a treadmill, stationary bicycling (arm or traditional leg), rowing on an ergometer), 30-60 minutes of strength training (major muscle groups of the trunk, upper and lower extremities) and 15-30 minutes of balance, agility, and mobility exercises. Participants will ramp up to this level depending on their previous activity levels, and initial measures.

Group Type: EXPERIMENTAL

Supervised in-person group

Intervention Type: BEHAVIORAL

Individually prescribed and directed/supervised by a fitness trainer in-person, multi-mode exercise 2 x a week for 30-60 minutes The fitness trainer is with the participant while they exercise.

Monitored Distance Group

For the monitored distance group, all activities will be performed at home or in a public gym environment near their home with prescribed plan provided by a fitness coach. The exercise intervention will have a goal of up to 120 minutes (60 minutes 2 x a week) of moderate intensity exercise, building up to that amount based on ability. This will include 45-60 minutes per week of cardiovascular activity (walking/jogging outside or on a treadmill, stationary bicycling (arm or traditional leg), rowing on an ergometer), 30-60 minutes of strength training (major muscle groups of the trunk, upper and lower extremities) and 15-30 minutes of balance, agility, and mobility exercises. Participants will ramp up to this level depending on their previous activity levels, and initial measures.

Group Type: EXPERIMENTAL

Monitored distance group

Intervention Type: BEHAVIORAL

Individually prescribed ulti-mode exercise 2 x a week for 30-60 minutes. Written plan/feedback and support by phone/text or email is provided by a fitness trainer who is not present with the participant when they exercise.

Interventions

Supervised in-person group

Individually prescribed and directed/supervised by a fitness trainer in-person, multi-mode exercise 2 x a week for 30-60 minutes The fitness trainer is with the participant while they exercise.

Intervention Type: BEHAVIORAL

Monitored distance group

Individually prescribed ulti-mode exercise 2 x a week for 30-60 minutes. Written plan/feedback and support by phone/text or email is provided by a fitness trainer who is not present with the participant when they exercise.

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• medical diagnosis of mild-moderate cognitive impairment
• medically cleared for exercise

Exclusion Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Foundation of Physical Therapy Research

UNKNOWN

Sponsor Role: collaborator

University of South Carolina

OTHER

Sponsor Role: lead

Responsible Party

Elizabeth Regan

Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Arnold School of Public Health

Columbia, South Carolina, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Elizabeth Regan, PhD

Role: CONTACT

eregan@mailbox.sc.edu

7046092409

Amberly Osteen

Role: CONTACT

Amberly.osteen@uscmed.sc.edu

(803) 216-3896

Facility Contacts

Elizabeth Regan

Role: primary

eregan@mailbox.sc.edu

7046092409

Other Identifiers

Pro00139826

Identifier Type: -

Identifier Source: org_study_id