Trial Outcomes & Findings for Feasibility of HIIT in Spinal Cord Injury (NCT NCT03152110)

NCT ID: NCT03152110

Last Updated: 2020-11-04

Results Overview

Number of HIIT Work/Rest Times (number of intervals) completed by the participants per session (averaged over all sessions and participants)

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 10 participants
• Primary outcome timeframe: To be recorded weekly, throughout study completion (3x/week for 6 weeks)
• Results posted on: 2020-11-04

Participant Flow

Participant milestones

Measure	HIIT Exercise sessions will be 3x/week for 6 weeks (2 sessions supervised, 1 session unsupervised). HIIT: A handcycle or tabletop ergometer will be used for HIIT. Exercise sessions will be scheduled 3x/week for 6 weeks (2 sessions supervised, 1 session unsupervised). The HIIT goal is to achieve 10 sets of 60 second bouts of arm cycling at 90% of their PPO with 60 seconds of active recovery. Supervised exercise sessions: Measures include HR, BP, RPEs, Feeling Scale, and PPO. After warming up, individualized work/rest phases will be prescribed based on their PPO from their maximal aerobic test. Participants will be held at 90% PPO as a constant target intensity to start, shortening the work phase, and if necessary, lengthening the recovery phase. These parameters will be progressed each session. The trainer will determine when to change their work/rest parameters
Overall Study STARTED	10
Overall Study COMPLETED	7
Overall Study NOT COMPLETED	3

Reasons for withdrawal

Measure

HIIT Exercise sessions will be 3x/week for 6 weeks (2 sessions supervised, 1 session unsupervised). HIIT: A handcycle or tabletop ergometer will be used for HIIT. Exercise sessions will be scheduled 3x/week for 6 weeks (2 sessions supervised, 1 session unsupervised). The HIIT goal is to achieve 10 sets of 60 second bouts of arm cycling at 90% of their PPO with 60 seconds of active recovery. Supervised exercise sessions: Measures include HR, BP, RPEs, Feeling Scale, and PPO. After warming up, individualized work/rest phases will be prescribed based on their PPO from their maximal aerobic test. Participants will be held at 90% PPO as a constant target intensity to start, shortening the work phase, and if necessary, lengthening the recovery phase. These parameters will be progressed each session. The trainer will determine when to change their work/rest parameters

Overall Study Withdrawal by Subject

3

Baseline Characteristics

Feasibility of HIIT in Spinal Cord Injury

Baseline characteristics by cohort

Measure	HIIT n=10 Participants Exercise sessions will be 3x/week for 6 weeks (2 sessions supervised, 1 session unsupervised). HIIT: A handcycle or tabletop ergometer will be used for HIIT. Exercise sessions will be scheduled 3x/week for 6 weeks (2 sessions supervised, 1 session unsupervised). The HIIT goal is to achieve 10 sets of 60 second bouts of arm cycling at 90% of their PPO with 60 seconds of active recovery. Supervised exercise sessions: Measures include HR, BP, RPEs, Feeling Scale, and PPO. After warming up, individualized work/rest phases will be prescribed based on their PPO from their maximal aerobic test. Participants will be held at 90% PPO as a constant target intensity to start, shortening the work phase, and if necessary, lengthening the recovery phase. These parameters will be progressed each session. The trainer will determine when to change their work/rest parameters
Age, Categorical <=18 years	1 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	9 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants
Age, Continuous	39.4 years STANDARD_DEVIATION 14.2 • n=5 Participants
Sex: Female, Male Female	3 Participants n=5 Participants
Sex: Female, Male Male	7 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	10 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants
Race (NIH/OMB) White	10 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Region of Enrollment United States	10 participants n=5 Participants
Wrist Pain	0.4 score on a scale STANDARD_DEVIATION 0.97 • n=5 Participants
Elbow Pain	0.6 score on a scale STANDARD_DEVIATION 1.1 • n=5 Participants
Shoulder Pain	0.75 score on a scale STANDARD_DEVIATION 1.5 • n=5 Participants
Shoulder Pain During Activity	8.5 score on a scale STANDARD_DEVIATION 21.4 • n=5 Participants
General Health & Function	80.4 score on a scale STANDARD_DEVIATION 12.6 • n=5 Participants
Physical Activity Status	24.8 score on a scale STANDARD_DEVIATION 11.3 • n=5 Participants

PRIMARY outcome

Timeframe: To be recorded weekly, throughout study completion (3x/week for 6 weeks)

Population: Analysis performed only on the numbers of participants who completed at least one HIIT training session (n=9)

Number of HIIT Work/Rest Times (number of intervals) completed by the participants per session (averaged over all sessions and participants)

Outcome measures

Measure

HIIT n=9 Participants Exercise sessions will be 3x/week for 6 weeks (2 sessions supervised, 1 session unsupervised). HIIT: A handcycle or tabletop ergometer will be used for HIIT. Exercise sessions will be scheduled 3x/week for 6 weeks (2 sessions supervised, 1 session unsupervised). The HIIT goal is to achieve 10 sets of 60 second bouts of arm cycling at 90% of their PPO with 60 seconds of active recovery. Supervised exercise sessions: Measures include HR, BP, RPEs, Feeling Scale, and PPO. After warming up, individualized work/rest phases will be prescribed based on their PPO from their maximal aerobic test. Participants will be held at 90% PPO as a constant target intensity to start, shortening the work phase, and if necessary, lengthening the recovery phase. These parameters will be progressed each session. The trainer will determine when to change their work/rest parameters based off of HR and RPEs. Unsupervised exercise sessions: Participants will repeat the same HIIT protocol they performed

HIIT Times

10 Intervals Standard Deviation 0

PRIMARY outcome

Timeframe: Baseline and 6 weeks

Population: The analysis was performed on the subset of subjects (n=6) who completed at least 12 supervised HIIT sessions and both the baseline and followup testing.

Change in peak power output (watts) pre and post HIIT training.

Outcome measures

Measure

HIIT n=6 Participants Exercise sessions will be 3x/week for 6 weeks (2 sessions supervised, 1 session unsupervised). HIIT: A handcycle or tabletop ergometer will be used for HIIT. Exercise sessions will be scheduled 3x/week for 6 weeks (2 sessions supervised, 1 session unsupervised). The HIIT goal is to achieve 10 sets of 60 second bouts of arm cycling at 90% of their PPO with 60 seconds of active recovery. Supervised exercise sessions: Measures include HR, BP, RPEs, Feeling Scale, and PPO. After warming up, individualized work/rest phases will be prescribed based on their PPO from their maximal aerobic test. Participants will be held at 90% PPO as a constant target intensity to start, shortening the work phase, and if necessary, lengthening the recovery phase. These parameters will be progressed each session. The trainer will determine when to change their work/rest parameters based off of HR and RPEs. Unsupervised exercise sessions: Participants will repeat the same HIIT protocol they performed

Power

5 Watts Standard Deviation 8.4

PRIMARY outcome

Timeframe: Baseline and 6 weeks

Population: The analysis was performed on the subset of subjects (n=6) who completed at least 12 supervised HIIT sessions and both the baseline and followup testing.

Change in Peak Oxygen Consumption (VO2) pre and post HIIT training (measured in mL/kg/min)

Outcome measures

Measure

HIIT n=6 Participants Exercise sessions will be 3x/week for 6 weeks (2 sessions supervised, 1 session unsupervised). HIIT: A handcycle or tabletop ergometer will be used for HIIT. Exercise sessions will be scheduled 3x/week for 6 weeks (2 sessions supervised, 1 session unsupervised). The HIIT goal is to achieve 10 sets of 60 second bouts of arm cycling at 90% of their PPO with 60 seconds of active recovery. Supervised exercise sessions: Measures include HR, BP, RPEs, Feeling Scale, and PPO. After warming up, individualized work/rest phases will be prescribed based on their PPO from their maximal aerobic test. Participants will be held at 90% PPO as a constant target intensity to start, shortening the work phase, and if necessary, lengthening the recovery phase. These parameters will be progressed each session. The trainer will determine when to change their work/rest parameters based off of HR and RPEs. Unsupervised exercise sessions: Participants will repeat the same HIIT protocol they performed

Cardiopulmonary Measures

0 ml/kg/min Standard Deviation 1.8

PRIMARY outcome

Timeframe: Recorded during each training session (3x/week for 6 weeks)

Population: Analysis performed only on the numbers of participants who completed at least one HIIT training session (n=9)

Peak heart rates achieved during each work interval within a training session were averaged together and then averaged over all training sessions and expressed as a percentage of the participant's maximum heart rate obtained at baseline, during training, or at the 6 week followup whichever value was highest. The peak training heart rates were then averaged across all participants to provide an overall measure of physical effort exerted by the group during HIIT exercise.

Outcome measures

Measure

HIIT n=9 Participants Exercise sessions will be 3x/week for 6 weeks (2 sessions supervised, 1 session unsupervised). HIIT: A handcycle or tabletop ergometer will be used for HIIT. Exercise sessions will be scheduled 3x/week for 6 weeks (2 sessions supervised, 1 session unsupervised). The HIIT goal is to achieve 10 sets of 60 second bouts of arm cycling at 90% of their PPO with 60 seconds of active recovery. Supervised exercise sessions: Measures include HR, BP, RPEs, Feeling Scale, and PPO. After warming up, individualized work/rest phases will be prescribed based on their PPO from their maximal aerobic test. Participants will be held at 90% PPO as a constant target intensity to start, shortening the work phase, and if necessary, lengthening the recovery phase. These parameters will be progressed each session. The trainer will determine when to change their work/rest parameters based off of HR and RPEs. Unsupervised exercise sessions: Participants will repeat the same HIIT protocol they performed

Cardiopulmonary Measures

94.1 percentage of maximum heart rate Standard Deviation 0.03

PRIMARY outcome

Timeframe: 6 weeks

Population: Analysis performed only on the numbers of participants who completed at least one HIIT training session (n=9)

Measured using the Physical Activity Enjoyment Scale (PACES). The summative score ranges from 18 to 126 with higher scores indicating higher levels of enjoyment

Outcome measures

Measure

HIIT n=9 Participants Exercise sessions will be 3x/week for 6 weeks (2 sessions supervised, 1 session unsupervised). HIIT: A handcycle or tabletop ergometer will be used for HIIT. Exercise sessions will be scheduled 3x/week for 6 weeks (2 sessions supervised, 1 session unsupervised). The HIIT goal is to achieve 10 sets of 60 second bouts of arm cycling at 90% of their PPO with 60 seconds of active recovery. Supervised exercise sessions: Measures include HR, BP, RPEs, Feeling Scale, and PPO. After warming up, individualized work/rest phases will be prescribed based on their PPO from their maximal aerobic test. Participants will be held at 90% PPO as a constant target intensity to start, shortening the work phase, and if necessary, lengthening the recovery phase. These parameters will be progressed each session. The trainer will determine when to change their work/rest parameters based off of HR and RPEs. Unsupervised exercise sessions: Participants will repeat the same HIIT protocol they performed

Enjoyment of HIIT

114.8 units on a scale Standard Deviation 11.3

PRIMARY outcome

Timeframe: 6 weeks

Population: Analysis performed only on the numbers of participants who completed at least one HIIT training session (n=9)

Measured using the scores on one question on the Exercise Evaluation Form: "Rate your overall experience with the exercise intervention". Scores ranged from 5 (Very Satisfied) to 1 (Very Dissatisfied).

Outcome measures

Measure

HIIT n=9 Participants Exercise sessions will be 3x/week for 6 weeks (2 sessions supervised, 1 session unsupervised). HIIT: A handcycle or tabletop ergometer will be used for HIIT. Exercise sessions will be scheduled 3x/week for 6 weeks (2 sessions supervised, 1 session unsupervised). The HIIT goal is to achieve 10 sets of 60 second bouts of arm cycling at 90% of their PPO with 60 seconds of active recovery. Supervised exercise sessions: Measures include HR, BP, RPEs, Feeling Scale, and PPO. After warming up, individualized work/rest phases will be prescribed based on their PPO from their maximal aerobic test. Participants will be held at 90% PPO as a constant target intensity to start, shortening the work phase, and if necessary, lengthening the recovery phase. These parameters will be progressed each session. The trainer will determine when to change their work/rest parameters based off of HR and RPEs. Unsupervised exercise sessions: Participants will repeat the same HIIT protocol they performed

Acceptability of HIIT

5 score on a scale Standard Deviation 0

PRIMARY outcome

Timeframe: To be recorded throughout study completion (6 weeks)

Population: Three participants were not included in the analysis because they had withdrawn from the study.

The number of participants who completed all the supervised training sessions (12 sessions over 6 weeks) as a percentage of the total number of participants who completed the 6 week study. The HIIT program was considered feasible if a majority of participants (80% or more) were able to complete all 12 supervised training sessions in the 6 week study time frame.

Outcome measures

Measure

HIIT n=7 Participants Exercise sessions will be 3x/week for 6 weeks (2 sessions supervised, 1 session unsupervised). HIIT: A handcycle or tabletop ergometer will be used for HIIT. Exercise sessions will be scheduled 3x/week for 6 weeks (2 sessions supervised, 1 session unsupervised). The HIIT goal is to achieve 10 sets of 60 second bouts of arm cycling at 90% of their PPO with 60 seconds of active recovery. Supervised exercise sessions: Measures include HR, BP, RPEs, Feeling Scale, and PPO. After warming up, individualized work/rest phases will be prescribed based on their PPO from their maximal aerobic test. Participants will be held at 90% PPO as a constant target intensity to start, shortening the work phase, and if necessary, lengthening the recovery phase. These parameters will be progressed each session. The trainer will determine when to change their work/rest parameters based off of HR and RPEs. Unsupervised exercise sessions: Participants will repeat the same HIIT protocol they performed

Percentage of Participants Completing All Supervised Training Sessions

85.7 percent of participants

SECONDARY outcome

Timeframe: Recorded during each training session (3x/week for 6 weeks)

Population: Analysis performed only on the numbers of participants who completed at least one HIIT training session (n=9)

The highest reported perceived exertion recorded during each HIIT exercise session was measured using the Borg Scale (6-20). The higher the number, the more perceived exertion felt during the activity. The perceived exertion ratings for all the sessions were averaged for each participant and then were averaged across all participants to provide an overall measure of perceived exertion felt by the group during HIIT exercise.

Outcome measures

Measure

HIIT n=9 Participants Exercise sessions will be 3x/week for 6 weeks (2 sessions supervised, 1 session unsupervised). HIIT: A handcycle or tabletop ergometer will be used for HIIT. Exercise sessions will be scheduled 3x/week for 6 weeks (2 sessions supervised, 1 session unsupervised). The HIIT goal is to achieve 10 sets of 60 second bouts of arm cycling at 90% of their PPO with 60 seconds of active recovery. Supervised exercise sessions: Measures include HR, BP, RPEs, Feeling Scale, and PPO. After warming up, individualized work/rest phases will be prescribed based on their PPO from their maximal aerobic test. Participants will be held at 90% PPO as a constant target intensity to start, shortening the work phase, and if necessary, lengthening the recovery phase. These parameters will be progressed each session. The trainer will determine when to change their work/rest parameters based off of HR and RPEs. Unsupervised exercise sessions: Participants will repeat the same HIIT protocol they performed

Perceived Exertion

18.8 score on a scale Standard Deviation 1.4

SECONDARY outcome

Timeframe: To be recorded during each training session (3x/week for 6 weeks)

Population: This scale was found to be redundant and confusing to participants as the questions were similar to the Borg Scale but the score anchoring was different. It was not recorded for any participants.

Measured using the Wheel Scale (6-20)

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Recorded during each training session (3x/week for 6 weeks)

Population: Analysis performed only on the numbers of participants who completed at least one HIIT training session (n=9)

Lowest feeling score reported during the HIIT training and averaged across participants. The Feeling Scale score ranges from -5 (very bad) to +5 (very good).

Outcome measures

Measure

HIIT n=9 Participants Exercise sessions will be 3x/week for 6 weeks (2 sessions supervised, 1 session unsupervised). HIIT: A handcycle or tabletop ergometer will be used for HIIT. Exercise sessions will be scheduled 3x/week for 6 weeks (2 sessions supervised, 1 session unsupervised). The HIIT goal is to achieve 10 sets of 60 second bouts of arm cycling at 90% of their PPO with 60 seconds of active recovery. Supervised exercise sessions: Measures include HR, BP, RPEs, Feeling Scale, and PPO. After warming up, individualized work/rest phases will be prescribed based on their PPO from their maximal aerobic test. Participants will be held at 90% PPO as a constant target intensity to start, shortening the work phase, and if necessary, lengthening the recovery phase. These parameters will be progressed each session. The trainer will determine when to change their work/rest parameters based off of HR and RPEs. Unsupervised exercise sessions: Participants will repeat the same HIIT protocol they performed

Feelings During HIIT

-0.11 units on a scale Standard Deviation 2.8

Adverse Events

HIIT

Serious events: 2 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Measure	HIIT n=10 participants at risk Exercise sessions will be 3x/week for 6 weeks (2 sessions supervised, 1 session unsupervised). HIIT: A handcycle or tabletop ergometer will be used for HIIT. Exercise sessions will be scheduled 3x/week for 6 weeks (2 sessions supervised, 1 session unsupervised). The HIIT goal is to achieve 10 sets of 60 second bouts of arm cycling at 90% of their PPO with 60 seconds of active recovery. Supervised exercise sessions: Measures include HR, BP, RPEs, Feeling Scale, and PPO. After warming up, individualized work/rest phases will be prescribed based on their PPO from their maximal aerobic test. Participants will be held at 90% PPO as a constant target intensity to start, shortening the work phase, and if necessary, lengthening the recovery phase. These parameters will be progressed each session. The trainer will determine when to change their work/rest parameters based off of HR and RPEs. Unsupervised exercise sessions: Participants will repeat the same HIIT protocol they performed
Skin and subcutaneous tissue disorders Pressure ulcer onset	10.0% 1/10 • 8 weeks
Musculoskeletal and connective tissue disorders Femur fracture from fall	10.0% 1/10 • 8 weeks

Other adverse events

Adverse event data not reported

Additional Information

Alicia Koontz

University of Pittsburgh

Phone: 412-822-3700

Email: akoontz@pitt.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place