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High Intensity Interval Exercise SCI

Primary Purpose

Spinal Cord Injuries, Cardiometabolic Diseases

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
high intensity interval exercise
No-exercise control group
Sponsored by
University of Alabama at Birmingham
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Spinal Cord Injuries focused on measuring High Intensity Interval Training, Telehealth Exercise, Armcrank Exercise, SCI

Eligibility Criteria

19 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. Men and women, 19-65 years of age.
  2. 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.
  3. At least 6 months post-injury.
  4. Able to independently operate an arm ergometer.
  5. Have access to a wireless internet connection.
  6. Medically stable, able to provide informed consent.

Exclusion Criteria:

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

    -

Sites / Locations

  • University of Alabama at Birmingham

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Other

Arm Label

High intensity interval exercise

No-Exercise Control

Arm Description

High intensity interval arm crank exercise

No-exercise control group

Outcomes

Primary Outcome Measures

Change in Aerobic Capacity
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.
Change in Aerobic Capacity
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.
Change in Muscular Strength
Muscle Strength Assessment. Maximal load that can be lifted in one repetition (1RM) will be assessed in both limbs for chest press, elbow flexion, and shoulder flexion maneuvers.
Change in Muscular Strength
Muscle Strength Assessment. Maximal load that can be lifted in one repetition (1RM) will be assessed in both limbs for chest press, elbow flexion, and shoulder flexion maneuvers.
Change in Insulin Sensitivity
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.
Change in Insulin Sensitivity
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.
Change in Blood Lipids
Laboratory analyses. Concentrations of blood lipids will be determined in the Core Laboratory of the CCTS, NORC, and DRC.
Change in Blood Lipids
Laboratory analyses. Concentrations of blood lipids will be determined in the Core Laboratory of the CCTS, NORC, and DRC.
Change in Body Composition
Dual-energy X-ray absorptiometry (DXA). Total and regional body composition will be measured by DXA (Lunar Radiation Corp., Madison, WI) at the Lakeshore Foundation Research Facility.
Change in Body Composition
Dual-energy X-ray absorptiometry (DXA). Total and regional body composition will be measured by DXA (Lunar Radiation Corp., Madison, WI) at the Lakeshore Foundation Research Facility.
Change in Blood Pressure
Systolic and Diastolic blood pressure will be assessed using standard blood pressure cuff and a stethoscope.
Change in Blood Pressure
Systolic and Diastolic blood pressure will be assessed using standard blood pressure cuff and a stethoscope.

Secondary Outcome Measures

Semi-Structured Interview
The semi-structured interviews will contain seven open-ended questions related to the following areas: 1) overall perceptions of the program, 2) program likes, 3) dislikes, 4) perceived satisfaction and 5) value, 6) technology and equipment usability, and 7) factors that affected adherence. These areas will be probed in greater detail by the interviewer through additional follow-up questions.

Full Information

First Posted
June 16, 2021
Last Updated
September 26, 2023
Sponsor
University of Alabama at Birmingham
Collaborators
National Institute of Nursing Research (NINR)
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1. Study Identification

Unique Protocol Identification Number
NCT04940598
Brief Title
High Intensity Interval Exercise SCI
Official Title
Telehealth High Intensity Interval Exercise and Cardiometabolic Health in Spinal Cord Injury
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Completed
Study Start Date
February 1, 2021 (Actual)
Primary Completion Date
July 31, 2023 (Actual)
Study Completion Date
July 31, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Alabama at Birmingham
Collaborators
National Institute of Nursing Research (NINR)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.
Detailed Description
For individuals with spinal cord injury (SCI), exercise participation reduces the risk of developing chronic cardiometabolic diseases, which are leading causes of rehospitalization and death within this population. Accordingly, recent SCI exercise guidelines have highlighted a need for exercise trials that can improve cardiometabolic factors such as glucose tolerance, blood lipids, blood pressure, and body composition. However, to date, the number of exercise trials examining these cardiometabolic outcomes in SCI is low, and these exercise regimens are often inconvenient for individuals with SCI to perform within their community. In addition to the functional impairment associated with the disability, individuals with SCI experience a number of barriers to exercise participation, such as lack of time (e.g. conflict with work schedule), accessible or usable equipment and facilities, and transportation. Thus, it is important to identify effective modes of exercise that can improve overall health but do not require a significant overall weekly time commitment. Investigators recently demonstrated that individuals with SCI could safely perform high intensity interval training (HIIT) using arm crank cycling and that as few as two days per week of HIIT could improve cardiometabolic health. Despite the advantages of HIIT, it is important to identify methods of implementing exercise trials that can successfully reach and maintain participation in larger cohorts. Recent work by the investigative group demonstrated that individuals with SCI expressed favorable perceptions of home-exercise training that incorporated telehealth technology, which allowed a fitness specialist to remotely monitor participants' training progress in real-time and provide verbal support via videoconferencing. This method of training holds even greater value for home-exercise programs that require monitoring to dose-specific protocols such as HIIT. However, the long-term success of HIIT will greatly depend on the ease at which the program can be implemented, as well as participants' adherence and perceptions of using the technology, which has not been investigated in SCI. The goal of this study is to integrate a home-based telehealth HIIT arm crank exercise training program in individuals with SCI and assess changes in cardiometabolic health and physical function. The secondary goal is to explore the uptake and implementation of HIIT in SCI. 40 participants will be randomized to home-based HIIT exercise or a no-exercise control group for 16-weeks. Body composition, aerobic fitness, muscular strength, and changes in cardiometabolic health will be assessed at baseline and 16-weeks post training. In addition to changes in cardiometabolic health outcomes, the investigators will also conduct interviews with participants to determine overall perceptions of the program, program likes and dislikes, perceived satisfaction and value, usability of equipment and technology, and factors that influence adherence.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Spinal Cord Injuries, Cardiometabolic Diseases
Keywords
High Intensity Interval Training, Telehealth Exercise, Armcrank Exercise, SCI

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
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
Masking
None (Open Label)
Allocation
Randomized
Enrollment
5 (Actual)

8. Arms, Groups, and Interventions

Arm Title
High intensity interval exercise
Arm Type
Experimental
Arm Description
High intensity interval arm crank exercise
Arm Title
No-Exercise Control
Arm Type
Other
Arm Description
No-exercise control group
Intervention Type
Other
Intervention Name(s)
high intensity interval exercise
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
No-exercise control group
Intervention Description
No-exercise control group
Primary Outcome Measure Information:
Title
Change in Aerobic Capacity
Description
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.
Time Frame
baseline
Title
Change in Aerobic Capacity
Description
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.
Time Frame
16weeks post training
Title
Change in Muscular Strength
Description
Muscle Strength Assessment. Maximal load that can be lifted in one repetition (1RM) will be assessed in both limbs for chest press, elbow flexion, and shoulder flexion maneuvers.
Time Frame
baseline
Title
Change in Muscular Strength
Description
Muscle Strength Assessment. Maximal load that can be lifted in one repetition (1RM) will be assessed in both limbs for chest press, elbow flexion, and shoulder flexion maneuvers.
Time Frame
16weeks post
Title
Change in Insulin Sensitivity
Description
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.
Time Frame
baseline
Title
Change in Insulin Sensitivity
Description
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.
Time Frame
16weeks post training
Title
Change in Blood Lipids
Description
Laboratory analyses. Concentrations of blood lipids will be determined in the Core Laboratory of the CCTS, NORC, and DRC.
Time Frame
baseline
Title
Change in Blood Lipids
Description
Laboratory analyses. Concentrations of blood lipids will be determined in the Core Laboratory of the CCTS, NORC, and DRC.
Time Frame
16weeks post training
Title
Change in Body Composition
Description
Dual-energy X-ray absorptiometry (DXA). Total and regional body composition will be measured by DXA (Lunar Radiation Corp., Madison, WI) at the Lakeshore Foundation Research Facility.
Time Frame
baseline
Title
Change in Body Composition
Description
Dual-energy X-ray absorptiometry (DXA). Total and regional body composition will be measured by DXA (Lunar Radiation Corp., Madison, WI) at the Lakeshore Foundation Research Facility.
Time Frame
16weeks post training
Title
Change in Blood Pressure
Description
Systolic and Diastolic blood pressure will be assessed using standard blood pressure cuff and a stethoscope.
Time Frame
baseline
Title
Change in Blood Pressure
Description
Systolic and Diastolic blood pressure will be assessed using standard blood pressure cuff and a stethoscope.
Time Frame
16weeks post training
Secondary Outcome Measure Information:
Title
Semi-Structured Interview
Description
The semi-structured interviews will contain seven open-ended questions related to the following areas: 1) overall perceptions of the program, 2) program likes, 3) dislikes, 4) perceived satisfaction and 5) value, 6) technology and equipment usability, and 7) factors that affected adherence. These areas will be probed in greater detail by the interviewer through additional follow-up questions.
Time Frame
16 weeks post-training

10. Eligibility

Sex
All
Minimum Age & Unit of Time
19 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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. Exclusion Criteria: 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 -
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gordon Fisher, PhD
Organizational Affiliation
University of Alabama at Birmingham
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Alabama at Birmingham
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35294
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
35927708
Citation
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.
Results Reference
derived

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High Intensity Interval Exercise SCI

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