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| ID | Type | Description | Link |
|---|---|---|---|
| R21NR019309 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute of Nursing Research (NINR) | NIH |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| High intensity interval exercise | Experimental | High intensity interval arm crank exercise |
|
| No-Exercise Control | Other | No-exercise control group |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
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
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| Name | Affiliation | Role |
|---|---|---|
| Gordon Fisher, PhD | University of Alabama at Birmingham | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Alabama at Birmingham | Birmingham | Alabama | 35294 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35927708 | Derived | 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. |
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Potential participants were identified by a computer-generated list of patients who are enrolled in the UAB SCI Model System and the Lakeshore Foundation Member Database and currently reside in the greater Birmingham, Alabama area. All potential participants were mailed a letter which describes the study, invites them to participate. Additional recruiting was done by posting fliers at the UAB Spain Rehabilitation Center (SRC) and Lakeshore Foundation.
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| ID | Title | Description |
|---|---|---|
| FG000 | High Intensity Interval Exercise | High intensity interval arm crank exercise high intensity interval exercise: 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. |
| FG001 | No-Exercise Control | No-exercise control group No-exercise control group: No-exercise control group |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | High Intensity Interval Exercise | High intensity interval arm crank exercise high intensity interval exercise: 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Posted | Mean | Standard Deviation | ml/kg/min | baseline |
|
18 weeks
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | High Intensity Interval Exercise | High intensity interval arm crank exercise high intensity interval exercise: 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. |
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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.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Gordon Fisher | UAB | 2059964114 | grdnfs@uab.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jul 13, 2023 | May 8, 2024 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Aug 11, 2021 | May 6, 2024 | ICF_001.pdf |
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| ID | Term |
|---|---|
| D013119 | Spinal Cord Injuries |
| ID | Term |
|---|---|
| D013118 | Spinal Cord Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D020196 | Trauma, Nervous System |
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| ID | Term |
|---|---|
| D000072696 | High-Intensity Interval Training |
| ID | Term |
|---|---|
| D064797 | Physical Conditioning, Human |
| D015444 | Exercise |
| D009043 | Motor Activity |
| D009068 | Movement |
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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
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|
| No-exercise control group | Other | No-exercise control group |
|
| 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 |
| BG001 | No-Exercise Control | No-exercise control group No-exercise control group: No-exercise control group |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants | No |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Height | Mean | Standard Deviation | inches |
|
| Body Weight | Mean | Standard Deviation | kg |
|
| VO2 Peak | Mean | Standard Deviation | ml/kg/min |
|
| Insulin Sensitivity | Mean | Standard Deviation | matsuda |
|
| Total Cholesterol | Mean | Standard Deviation | mg/dl |
|
| Triglycerides | Mean | Standard Deviation | mg/dl |
|
| HDL | Mean | Standard Deviation | mg/dl |
|
| LDL | Mean | Standard Deviation | mg/dl |
|
| Fasting Glucose | Mean | Standard Deviation | mg/dl |
|
| Fasting Insulin | Mean | Standard Deviation | mIU/L |
|
| OG001 | No-Exercise Control | No-exercise control group No-exercise control group: No-exercise control group |
|
|
| Primary | 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. | Posted | Mean | Standard Deviation | ml/kg/min | 16weeks post training |
|
|
|
| Primary | 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, | Posted | Mean | Standard Deviation | score on a scale | baseline |
|
|
|
| Primary | 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, | Posted | Mean | Standard Deviation | score on a scale | 16weeks post training |
|
|
|
| Primary | Cholesterol Baseline | Laboratory analyses. Concentrations of blood lipids will be determined in the Core Laboratory of the CCTS, NORC, and DRC. | Posted | Mean | Standard Deviation | mg/dl | baseline |
|
|
|
| Primary | Cholesterol Week 16 | Laboratory analyses. Concentrations of blood lipids will be determined in the Core Laboratory of the CCTS, NORC, and DRC. | Posted | Mean | Standard Deviation | mg/dl | 16weeks post training |
|
|
|
| Primary | Body Composition Baseline | Dual-energy X-ray absorptiometry (DXA). Percent Body Fat | Posted | Mean | Standard Deviation | Percent Fat | baseline |
|
|
|
| Primary | Body Composition Week 16 | Dual-energy X-ray absorptiometry (DXA). Percent Body Fat | Posted | Mean | Standard Deviation | Percent Fat | 16weeks post training |
|
|
|
| Primary | Triglycerides Baseline | Laboratory analyses. Concentrations of blood lipids will be determined in the Core Laboratory of the CCTS, NORC, and DRC. | Posted | Mean | Standard Deviation | mg/dl | baseline |
|
|
|
| Primary | Triglycerides Week 16 | Laboratory analyses. Concentrations of blood lipids will be determined in the Core Laboratory of the CCTS, NORC, and DRC. | Posted | Mean | Standard Deviation | mg/dl | 16-weeks post |
|
|
|
| Primary | HDL Baseline | Laboratory analyses. Concentrations of blood lipids will be determined in the Core Laboratory of the CCTS, NORC, and DRC. | Posted | Mean | Standard Deviation | mg/dl | Baseline |
|
|
|
| Primary | HDL Week 16 | Laboratory analyses. Concentrations of blood lipids will be determined in the Core Laboratory of the CCTS, NORC, and DRC. | Posted | Mean | Standard Deviation | mg/dl | 16-weeks post training |
|
|
|
| Primary | LDL Baseline | Laboratory analyses. Concentrations of blood lipids will be determined in the Core Laboratory of the CCTS, NORC, and DRC. | Posted | Mean | Standard Deviation | mg/dl | Baseline |
|
|
|
| Primary | LDL Week 16 | Laboratory analyses. Concentrations of blood lipids will be determined in the Core Laboratory of the CCTS, NORC, and DRC. | Posted | Mean | Standard Deviation | mg/dl | 16-weeks post training |
|
|
|
| 0 |
| 5 |
| 0 |
| 5 |
| 0 |
| 5 |
| EG001 | No-Exercise Control | No-exercise control group No-exercise control group: No-exercise control group | 0 | 3 | 0 | 3 | 0 | 3 |
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| D014947 | Wounds and Injuries |
| D009142 |
| Musculoskeletal Physiological Phenomena |
| D055687 | Musculoskeletal and Neural Physiological Phenomena |