Spinal Cord InjuriesNCT04940598

High Intensity Interval Exercise SCI

A study testing high intensity interval exercise in people with Spinal Cord Injuries and Cardiometabolic Diseases, run by University of Alabama at Birmingham at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 19 to 65 years
Conditions the study is for: Spinal Cord Injuries, Cardiometabolic Diseases
What is being tested?: high intensity interval exercise
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 8 participants
Where: 1 siteUnited States
Study dates: 1 Feb 2021to 31 Jul 2023
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 19 to 65 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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.

Who cannot join

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
-

Trial locations and contacts

1 site in 1 country.

United States1 site

University of Alabama at Birmingham
Birmingham, Alabama, 35294

Other trials in United States

About this study

Official title: Telehealth High Intensity Interval Exercise and Cardiometabolic Health in Spinal Cord Injury

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.

Read the 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.

Conditions: Spinal Cord Injuries, Cardiometabolic Diseases
Being tested: high intensity interval exercise, No-exercise control group
Keywords: High Intensity Interval Training, Telehealth Exercise, Armcrank Exercise, SCI
Medical subject headings: Spinal Cord Injuries

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

high intensity interval exerciseOther
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.
No-exercise control groupOther
No-exercise control group

Study groups in NCT04940598
Study group	Role	What they receive
High intensity interval exercise	Experimental	High intensity interval arm crank exercise Receives: Other: high intensity interval exercise
No-Exercise Control	Other	No-exercise control group Receives: Other: No-exercise control group

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: 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.
Measured: 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,
Measured: 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,
Measured: 16weeks post training
Cholesterol Baseline
Laboratory analyses. Concentrations of blood lipids will be determined in the Core Laboratory of the CCTS, NORC, and DRC.
Measured: baseline
Cholesterol Week 16
Laboratory analyses. Concentrations of blood lipids will be determined in the Core Laboratory of the CCTS, NORC, and DRC.
Measured: 16weeks post training
Body Composition Baseline
Dual-energy X-ray absorptiometry (DXA). Percent Body Fat
Measured: baseline
Body Composition Week 16
Dual-energy X-ray absorptiometry (DXA). Percent Body Fat
Measured: 16weeks post training
Triglycerides Baseline
Laboratory analyses. Concentrations of blood lipids will be determined in the Core Laboratory of the CCTS, NORC, and DRC.
Measured: baseline
Triglycerides Week 16
Laboratory analyses. Concentrations of blood lipids will be determined in the Core Laboratory of the CCTS, NORC, and DRC.
Measured: 16-weeks post
HDL Baseline
Laboratory analyses. Concentrations of blood lipids will be determined in the Core Laboratory of the CCTS, NORC, and DRC.
Measured: Baseline
HDL Week 16
Laboratory analyses. Concentrations of blood lipids will be determined in the Core Laboratory of the CCTS, NORC, and DRC.
Measured: 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.
Measured: Baseline
LDL Week 16
Laboratory analyses. Concentrations of blood lipids will be determined in the Core Laboratory of the CCTS, NORC, and DRC.
Measured: 16-weeks post training

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1 Feb 202131 Jul 2023

First posted25 Jun 2021
Study start1 Feb 2021
Primary completion31 Jul 2023
Study completion31 Jul 2023

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Spinal Cord InjuriesStudies of the same condition, open and under way.
More trials run by University of Alabama at BirminghamThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
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)
Enrolment: 8 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04940598
Sponsor's protocol ID: 000526083
Other IDs: R21NR019309
Status last verified: Jul 2024
First submitted: 16 Jun 2021
Last updated: 24 Jul 2024
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No

Publications

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.
PubMed 35927708

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Spinal Cord Injuries trials

Study at a glance

From the registry record, last updated by the sponsor on 24 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Telehealth High Intensity Interval Exercise and Cardiometabolic Health in Spinal Cord Injury
ClinicalTrials.gov ID: NCT04940598
Acronym / sponsor ID: 000526083
Conditions: Spinal Cord Injuries, Cardiometabolic Diseases
Keywords: High Intensity Interval Training, Telehealth Exercise, Armcrank Exercise, SCI
Study type: Interventional
Recruitment status: Completed
Enrolment: 8 participants (actual)
Lead sponsor: University of Alabama at BirminghamUniversity, hospital or other
Collaborators: National Institute of Nursing Research (NINR)
Study start: 1 Feb 2021 (actual)
Primary completion: 31 Jul 2023 (actual)
Study completion: 31 Jul 2023 (actual)
First posted: 25 Jun 2021 (actual)
Results: Posted 24 Jul 2024

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2
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

Arm	Type	Receives
High intensity interval exercise	Experimental	Other: high intensity interval exerciseHigh intensity interval arm crank exercise
No-Exercise Control	Other	Other: No-exercise control groupNo-exercise control group

Who may qualify

Ages: 19 to 65 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (6 listed)

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.

Key exclusion criteria (8 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
high intensity interval exerciseHIIT 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.	Other	High intensity interval exercise
No-exercise control groupNo-exercise control group	Other	No-Exercise Control

Primary outcome

Aerobic Capacity Baseline
Time frame: 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.
Aerobic Capacity Week 16
Time frame: 16weeks post training
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.
Matsuda Index Baseline
Time frame: 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,
Matsuda Index Week 16
Time frame: 16weeks post training
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,
Cholesterol Baseline
Time frame: baseline
Laboratory analyses. Concentrations of blood lipids will be determined in the Core Laboratory of the CCTS, NORC, and DRC.
Cholesterol Week 16
Time frame: 16weeks post training
Laboratory analyses. Concentrations of blood lipids will be determined in the Core Laboratory of the CCTS, NORC, and DRC.
Body Composition Baseline
Time frame: baseline
Dual-energy X-ray absorptiometry (DXA). Percent Body Fat
Body Composition Week 16
Time frame: 16weeks post training
Dual-energy X-ray absorptiometry (DXA). Percent Body Fat
Triglycerides Baseline
Time frame: baseline
Laboratory analyses. Concentrations of blood lipids will be determined in the Core Laboratory of the CCTS, NORC, and DRC.
Triglycerides Week 16
Time frame: 16-weeks post
Laboratory analyses. Concentrations of blood lipids will be determined in the Core Laboratory of the CCTS, NORC, and DRC.
HDL Baseline
Time frame: Baseline
Laboratory analyses. Concentrations of blood lipids will be determined in the Core Laboratory of the CCTS, NORC, and DRC.
HDL Week 16
Time frame: 16-weeks post training
Laboratory analyses. Concentrations of blood lipids will be determined in the Core Laboratory of the CCTS, NORC, and DRC.
LDL Baseline
Time frame: Baseline
Laboratory analyses. Concentrations of blood lipids will be determined in the Core Laboratory of the CCTS, NORC, and DRC.
LDL Week 16
Time frame: 16-weeks post training
Laboratory analyses. Concentrations of blood lipids will be determined in the Core Laboratory of the CCTS, NORC, and DRC.

Results and safety

Results posted to the registry on 24 Jul 2024, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
High Intensity Interval Exercise	5	5
No-Exercise Control	3	3

Primary outcome: Aerobic Capacity Baseline

Time frame: baseline. Mean (Standard Deviation). Unit: ml/kg/min

Measure	High Intensity Interval Exercise n = 5	No-Exercise Control n = 3
Value	11.6 (2.9)	10 (.99)

Primary outcome: Aerobic Capacity Week 16

Time frame: 16weeks post training. Mean (Standard Deviation). Unit: ml/kg/min

Measure	High Intensity Interval Exercise n = 5	No-Exercise Control n = 3
Value	13.6 (2.2)	9.9 (2.5)

Primary outcome: Matsuda Index Baseline

Time frame: baseline. Mean (Standard Deviation). Unit: score on a scale

Measure	High Intensity Interval Exercise n = 5	No-Exercise Control n = 3
Value	3.5 (1.8)	6.1 (4.2)

Primary outcome: Matsuda Index Week 16

Time frame: 16weeks post training. Mean (Standard Deviation). Unit: score on a scale

Measure	High Intensity Interval Exercise n = 5	No-Exercise Control n = 3
Value	5.3 (3.5)	6.5 (5.9)

Adverse events

Time frame: 18 weeks. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
High Intensity Interval Exercise	0 of 5 (0%)	0 of 5 (0%)	0 of 5
No-Exercise Control	0 of 3 (0%)	0 of 3 (0%)	0 of 3

Limitations and caveats (from the sponsor): 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.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 24 Jul 2024.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 35927708Adams 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.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Gordon Fisher, PhD principal investigator

University of Alabama at Birmingham

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing high intensity interval exercise in people with Spinal Cord Injuries and Cardiometabolic Diseases, run by University of Alabama at Birmingham at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 24 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 24 Jul 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Aerobic Capacity Baseline (time frame: baseline). The study lists 14 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04940598, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jul 2024.