Clinical trial NCT06945835: High Intensity Exercise and Improving Physical Activity Among People With Neurologic Dysfunction
Official title: Can a High Intensity Exercise Program for People With Neurologic Disabilities Run by Doctoral of Physical Therapy Students Improve Mobility in Everyday Life
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Cerebral Palsy (CP)
Stroke
Spinal Cord Injury
Traumatic Brain Injury
Charcot Marie Tooth Disease (CMT)
Spina Bifida
Keywords: high intensity exercise
physical activity
physical disability
Lead sponsor: University of Hartford
Sponsor class: OTHER
First posted: 2025-04-25
Enrollment: 15
Sex: ALL
Minimum age (years): 8
Maximum age (years): 99
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Pre test post test design.
Primary purpose: TREATMENT

Brief summary: The Hawks in Motion (HIM) High Intensity Exercise program is designed to implement the American Physical Therapy Clinical Practice Guidelines and American College of Sports Medicine recommendations for exercise for people with neurologic disability. Doctor of Physical Therapy (DPT) students administer the HIM High Intensity Exercise Program. A prior study evaluated the feasibility, safety, and efficacy of the HIM High Intensity Exercise Program and found it feasible, safe, and effective for 30 people with neurologic disabilities between the ages of 8-99 years. The investigators would like to evaluate whether participation in the HIM High Intensity Exercise Program affects mobility in everyday life. Physical activity will be measured one week before program implementation and one week after to assess if the participants' mobility in everyday improved.

Detailed description: The neurological conditions of spinal cord injury (SCI), stroke (CVA), traumatic brain injury (TBI), cerebral palsy (CP), Charcot-Marie-Tooth (CMT), and Parkinson's disease (PD) create a variety of physical impairments that make movement difficult. For example, people with SCI can have complete or partial paralysis of the arms, legs, and or trunk depending on the location and severity of injury. People with CMT have paralysis in specific muscles of the hands, feet, and trunk. Similarly, people with TBI, CVA, and CP can experience increased muscle tone, decreased voluntary movement, and difficulty moving at correct speeds. This makes walking, moving surface to surface, and doing other physical activities difficult, frustrating, and tiring. People tend not to move, and end up with chronic pain, heart disease, diabetes, and poor health. Physical inactivity is one of the most concerning issues among individuals with chronic neurological conditions, often resulting in limited community participation and reduced quality of life. Many individuals with these conditions struggle to achieve sufficient physical activity levels necessary for functional independence and movement in the community, essential for maintaining social connections and overall well-being. Despite the known benefits of moderate-to-vigorous physical activity, challenges persist in improving mobility in community settings. It has been hypothesized that by increasing function and endurance, which the HIM High Intensity Program can do, mobility in everyday life may improve. The purpose of the project is to see if physical activity among individuals with chronic neurological disabilities can be increased by participation in a community-based exercise program. The investigators would like to answer the following research question: Does participation in an 8-week, twice-a-week high-intensity exercise program for people with neurologic disability run by Doctor of Physical Therapy students increase physical activity in the everyday life?

Eligibility criteria: Inclusion Criteria:

* physical disability that limits mobility and activities of daily living, and a neurodevelopmental disability OR neurological disability,
* age 8-99 years of age,
* understands verbal instructions,
* able to obtain medical clearance,
* able to obtain transportation to campus,
* have a parent/guardian/caregiver on site if not own legal authorized representative,
* English speaking.

Exclusion Criteria:

* no presence of a physical disability that impacts activities of daily living, no neurodevelopmental or neurological disability as an underlying cause,
* no person-centered goals (locomotion, fitness, transfers, and mobility),
* unstable cardiac condition,
* uncontrolled seizures,
* unstable oxygen saturation levels,
* no clearance from primary care physician for exercise,
* unable to read and understand English,
* pursuing active litigation for their physical condition.

Primary outcomes:
measure: Functional Gait Assessment-(FGA)
timeFrame: Baseline and through study completion, an average of 8 weeks
measure: Canadian Occupational Performance Measure (COPM)
timeFrame: Baseline and through study completion, an average of 8 weeks
measure: Berg Balance Scale- (BBS)
timeFrame: Baseline and through study completion, an average of 8 weeks
measure: Activities-Specific Balance Confidence Scale (ABS)
timeFrame: Baseline and through study completion, an average of 8 weeks
measure: 10 Meter Walk Test- (10MWT)
timeFrame: Baseline and through study completion, an average of 8 weeks
measure: 5 Times Sit to Stand: (5XSTS)
timeFrame: Baseline and through study completion, an average of 8 weeks
measure: Timed 30 second repetition arm curl.
timeFrame: Baseline and through study completion, an average of 8 weeks
measure: Timed 30 second Wheelchair Push Ups.
timeFrame: Baseline and through study completion, an average of 8 weeks
measure: Six minute walk test (6MWT)/6 minute push test)
timeFrame: Baseline and through study completion, an average of 8 weeks
Secondary outcomes:
measure: Physical Activity Monitoring
timeFrame: Baseline and through study completion, an average of 8 weeks
Other outcomes:
Locations:
city: West Hartford
country: United States
facility: University of Hartford
state: Connecticut
Study officials:
References: