High Intensity Interval Exercise SCI

NCT04940598 | Completed Results DMC

• 2 other identifiers: 000526083R21NR019309
• Study Type: interventional
• Target: 8
• Locations: 1 country
• Sites: 1

Brief Summary

This study will determine if the implementation of a home-based telehealth high intensity interval exercise-training (HIIT)program can significantly improve cardiometabolic health and physical function in a cohort of individuals with longstanding spinal cord injury (SCI). Results from this study will determine feasibility, overall enjoyment, and health impact of implementing a home-based telehealth HIIT program in individuals with SCI.

Conditions

Spinal Cord Injuries; Cardiometabolic Diseases

Keywords

High Intensity Interval Training; Telehealth Exercise; Armcrank Exercise; SCI

Outcome Measures

Primary Outcomes (14)

• Aerobic Capacity Baseline

  All subjects will undergo a progressive peak oxygen assessment to determine aerobic capacity at the Lakeshore Foundation Exercise Physiology Facility. Subjects will be instructed to perform arm crank ergometer (Lode) at 10W for 2 min. Every 2 min thereafter, power output will be increased by 10W until voluntary fatigue. Peak aerobic power will be defined as VO2 at the point of failure to maintain 60-65 rotations per minute.

  baseline

• Aerobic Capacity Week 16

  All subjects will undergo a progressive peak oxygen assessment to determine aerobic capacity at the Lakeshore Foundation Exercise Physiology Facility. Subjects will be instructed to perform arm crank ergometer (Lode) at 10W for 2 min. Every 2 min thereafter, power output will be increased by 10W until voluntary fatigue. Peak aerobic power will be defined as VO2 at the point of failure to maintain 60-65 rotations per minute.

  16weeks post training

• Matsuda Index Baseline

  Oral glucose tolerance test. Following an overnight fast each subject will consume a 75g oral glucose load within 5 min. Blood samples will be collected immediately before and 60, 90, and 120 min following glucose ingestion for measurement of serum glucose and serum insulin. Insulin sensitivity was calculated using glucose and insulin values by the Matsuda Index, in which a higher number demonstrates an improvement in insulin sensitivity,

  baseline

• Matsuda Index Week 16

  Oral glucose tolerance test. Following an overnight fast each subject will consume a 75g oral glucose load within 5 min. Blood samples will be collected immediately before and 60, 90, and 120 min following glucose ingestion for measurement of serum glucose and serum insulin. Insulin sensitivity was calculated using glucose and insulin values by the Matsuda Index, in which a higher number demonstrates an improvement in insulin sensitivity,

  16weeks post training

• Cholesterol Baseline

  Laboratory analyses. Concentrations of blood lipids will be determined in the Core Laboratory of the CCTS, NORC, and DRC.

  baseline

• Cholesterol Week 16

  Laboratory analyses. Concentrations of blood lipids will be determined in the Core Laboratory of the CCTS, NORC, and DRC.

  16weeks post training

• Body Composition Baseline

  Dual-energy X-ray absorptiometry (DXA). Percent Body Fat

  baseline

• Body Composition Week 16

  Dual-energy X-ray absorptiometry (DXA). Percent Body Fat

  16weeks post training

• Triglycerides Baseline

  Laboratory analyses. Concentrations of blood lipids will be determined in the Core Laboratory of the CCTS, NORC, and DRC.

  baseline

• Triglycerides Week 16

  Laboratory analyses. Concentrations of blood lipids will be determined in the Core Laboratory of the CCTS, NORC, and DRC.

  16-weeks post

• HDL Baseline

  Laboratory analyses. Concentrations of blood lipids will be determined in the Core Laboratory of the CCTS, NORC, and DRC.

  Baseline

• HDL Week 16

  Laboratory analyses. Concentrations of blood lipids will be determined in the Core Laboratory of the CCTS, NORC, and DRC.

  16-weeks post training

• LDL Baseline

  Laboratory analyses. Concentrations of blood lipids will be determined in the Core Laboratory of the CCTS, NORC, and DRC.

  Baseline

• LDL Week 16

  Laboratory analyses. Concentrations of blood lipids will be determined in the Core Laboratory of the CCTS, NORC, and DRC.

  16-weeks post training

Study Arms (2)

High intensity interval exercise

EXPERIMENTAL

High intensity interval arm crank exercise

Other: high intensity interval exercise

No-Exercise Control

OTHER

No-exercise control group

Other: No-exercise control group

Interventions

high intensity interval exercise OTHER

HIIT training will be delivered two times per week for 16 weeks (32 sessions). Each session will be separated by at least 24-hrs. Participants will be allowed to choose the days and times that they feel exercise will fit into their schedule. The HIIT protocol will be determined based on peak anaerobic power measures during an arm crank Wingate Cycle test. HIIT will consist of 20 minutes of exercise consisting of four minutes of arm crank exercise at 5% of peak anaerobic power followed by 30 seconds at 30% of the peak anaerobic power; this cycle will be repeated four times, ending with two minutes of recovery at 5% of peak anaerobic power.

High intensity interval exercise

No-exercise control group OTHER

No-exercise control group

No-Exercise Control

Eligibility Criteria

• Age: 19 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Men and women, 19-65 years of age.
• Confirmed diagnosis of traumatic SCI at the cervical or thoracic level (C7-T12), classified as A, B, C, or D (motor and sensory complete or incomplete) on the AIS scale.
• At least 6 months post-injury.
• Able to independently operate an arm ergometer.
• Have access to a wireless internet connection.
• Medically stable, able to provide informed consent.

You may not qualify if:

• Cardiovascular or renal diseases.
• Pregnant women
• Orthopedic conditions that prevents arm ergomtery
• Upper extremity musculoskeletal conditions that prevents arm ergometry.
• Neurological disorder that prevents arm ergometry
• Participation in a structured exercise program currently or in the past 3 months.
• Unable to perform exercise interventions

Sponsors & Collaborators

• University of Alabama at Birmingham: lead
• National Institute of Nursing Research (NINR): collaborator

Study Sites (1)

University of Alabama at Birmingham

Birmingham, Alabama, 35294, United States

Location

Related Publications (1)

• 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: 35927708 DERIVED

MeSH Terms

Conditions

Spinal Cord Injuries

Interventions

High-Intensity Interval Training

Condition Hierarchy (Ancestors)

Spinal Cord Diseases; Central Nervous System Diseases; Nervous System Diseases; Trauma, Nervous System; Wounds and Injuries

Intervention Hierarchy (Ancestors)

Physical Conditioning, Human; Exercise; Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Limitations and Caveats

Limitations in this study include a small sample size. We were only able to recruit a total of 5 participants for this study, we had 5 participate in the exercise group and 3 in the control group. We modified the protocol at the end of year 2 to enable a wait-listed control group that would allow those assigned to the control condition the option to participate in the exercise arm of the study as well. COVID made it difficult to enroll participants for the first 2 years.

Results Point of Contact

• Title: Gordon Fisher
• Organization: UAB

grdnfs@uab.edu

2059964114

Study Officials

• Gordon Fisher, PhD

  University of Alabama at Birmingham

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Model Details: In a longitudinal study design, 40 participants with chronic SCI will be randomly assigned to one of the two study groups (HIIT and control) in a 1:1 ratio. Randomization will be performed using the block randomization method, Randomization will be performed using the block randomization method. A randomization list will be generated and assignments will be placed into closed envelopes and given to each study participant. Participants will be assessed at baseline and 16-wks post HIIT or control

Study Record Dates

• First Submitted: June 16, 2021
• First Posted: June 25, 2021
• Study Start: February 1, 2021
• Primary Completion: July 31, 2023
• Study Completion: July 31, 2023
• Last Updated: July 24, 2024
• Results First Posted: July 24, 2024

Record last verified: 2024-07

Locations

US (1)