NCT05951985

Brief Summary

Individuals with and without neurologic diagnoses greatly benefit from participation in regular exercise but the majority are physically inactive. This is an issue for both them and their care partners as their health is often linked. This study aims to examine the long-term physical and psychosocial effects of structured, group-based, high intensity functional training (HIFT) exercise for people with neurologic diagnoses and their care partners.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Aug 2023

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 11, 2023

Completed
8 days until next milestone

First Posted

Study publicly available on registry

July 19, 2023

Completed
27 days until next milestone

Study Start

First participant enrolled

August 15, 2023

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 14, 2025

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

August 14, 2025

Completed
Last Updated

August 22, 2025

Status Verified

August 1, 2025

Enrollment Period

1.9 years

First QC Date

July 11, 2023

Last Update Submit

August 17, 2025

Conditions

Keywords

hiftexercise

Outcome Measures

Primary Outcomes (1)

  • Participant Attendance at 24 months

    The percentage of intervention sessions attended by participants.

    After 24 months of intervention

Secondary Outcomes (24)

  • Change in lower extremity functional strength at 24 months

    After, 3, 6, 9, 12, 15, 18, 21 and 24 months of intervention

  • hange in Parkinson's Disease Questionnaire - 39 (PDQ-39) at 24 months

    After, 3, 6, 9, 12, 15, 18, 21 and 24 months of intervention

  • Change in fast-paced gait speed at 24 months

    After, 3, 6, 9, 12, 15, 18, 21 and 24 months of intervention

  • Change in fast-paced wheelchair propulsion speed at 24 months

    After, 3, 6, 9, 12, 15, 18, 21 and 24 months of intervention

  • Change in 6 Minute Walk Test at 24 months

    After, 3, 6, 9, 12, 15, 18, 21 and 24 months of intervention

  • +19 more secondary outcomes

Study Arms (1)

HIFT Exercise

EXPERIMENTAL

In this single group design, all participants will be provided with up to two years of twice weekly supervised group exercise.

Behavioral: HIFT

Interventions

HIFTBEHAVIORAL

Exercise sessions will be 60 to 75 minutes in duration and be a combination of resistance, aerobic, and balance exercise, with emphasis on functional movements performed at a high intensity. Exercises will be tailored/modified to meet the needs of each participant.

HIFT Exercise

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Participants must be at least 18 years of age
  • Participants must be able to communicate and read in English
  • Participants must have physician and/or advanced practice provider clearance to exercise
  • Participants must have a neurologic diagnosis (e.g., spinal cord injury, Parkinson's, brain injury, stroke, poliomyelitis, multiple sclerosis, spina bifida, etc.) OR participants must be care partner of a person with neurologic diagnosis.
  • Participants must possess at least 4/5 elbow flexion strength bilaterally
  • Participants must be able to locomote independently (i.e., ambulate or propel a manual or power wheelchair independently).
  • Participants must provide their own transportation to/from the research study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Arkansas Colleges of Health Education

Fort Smith, Arkansas, 72916, United States

Location

Related Publications (4)

  • Schenkman M, Moore CG, Kohrt WM, Hall DA, Delitto A, Comella CL, Josbeno DA, Christiansen CL, Berman BD, Kluger BM, Melanson EL, Jain S, Robichaud JA, Poon C, Corcos DM. Effect of High-Intensity Treadmill Exercise on Motor Symptoms in Patients With De Novo Parkinson Disease: A Phase 2 Randomized Clinical Trial. JAMA Neurol. 2018 Feb 1;75(2):219-226. doi: 10.1001/jamaneurol.2017.3517.

    PMID: 29228079BACKGROUND
  • Ellis TD, Cavanaugh JT, DeAngelis T, Hendron K, Thomas CA, Saint-Hilaire M, Pencina K, Latham NK. Comparative Effectiveness of mHealth-Supported Exercise Compared With Exercise Alone for People With Parkinson Disease: Randomized Controlled Pilot Study. Phys Ther. 2019 Feb 1;99(2):203-216. doi: 10.1093/ptj/pzy131.

    PMID: 30715489BACKGROUND
  • Feito Y, Heinrich KM, Butcher SJ, Poston WSC. High-Intensity Functional Training (HIFT): Definition and Research Implications for Improved Fitness. Sports (Basel). 2018 Aug 7;6(3):76. doi: 10.3390/sports6030076.

    PMID: 30087252BACKGROUND
  • Adams J, Lai B, Rimmer J, Powell D, Yarar-Fisher C, Oster RA, Fisher G. Telehealth high-intensity interval exercise and cardiometabolic health in spinal cord injury. Trials. 2022 Aug 4;23(1):633. doi: 10.1186/s13063-022-06585-2.

    PMID: 35927708BACKGROUND

MeSH Terms

Conditions

Nervous System DiseasesParkinson DiseaseSpinal Cord InjuriesSpinal DysraphismStrokePoliomyelitisMultiple SclerosisBrain InjuriesMotor Activity

Condition Hierarchy (Ancestors)

Parkinsonian DisordersBasal Ganglia DiseasesBrain DiseasesCentral Nervous System DiseasesMovement DisordersSynucleinopathiesNeurodegenerative DiseasesSpinal Cord DiseasesTrauma, Nervous SystemWounds and InjuriesNeural Tube DefectsNervous System MalformationsCongenital AbnormalitiesCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesCerebrovascular DisordersVascular DiseasesCardiovascular DiseasesMyelitisCentral Nervous System InfectionsInfectionsEnterovirus InfectionsPicornaviridae InfectionsRNA Virus InfectionsVirus DiseasesNeuroinflammatory DiseasesNeuromuscular DiseasesDemyelinating Autoimmune Diseases, CNSAutoimmune Diseases of the Nervous SystemDemyelinating DiseasesAutoimmune DiseasesImmune System DiseasesCraniocerebral TraumaBehavior

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Model Details: Longitudinal with assessments occurring quarterly over the course of two years
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

July 11, 2023

First Posted

July 19, 2023

Study Start

August 15, 2023

Primary Completion

July 14, 2025

Study Completion

August 14, 2025

Last Updated

August 22, 2025

Record last verified: 2025-08

Locations