Trial Outcomes & Findings for High Intensity Interval Training in Chronic Stroke (NCT NCT01958606)

NCT ID: NCT01958606

Last Updated: 2017-05-15

Results Overview

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 18 participants
• Primary outcome timeframe: Baseline and 4 weeks
• Results posted on: 2017-05-15

Participant Flow

Participant milestones

Measure	High-intensity Interval Training (HIT) Treadmill exercise using bursts of concentrated effort alternated with recovery periods High-intensity interval training (HIT): Treadmill exercise using bursts of concentrated effort alternated with recovery periods	Traditional Aerobic Training Moderate intensity continuous aerobic exercise on a treadmill Traditional Aerobic Training: Moderate intensity continuous aerobic exercise on a treadmill
Overall Study STARTED	13	5
Overall Study COMPLETED	11	5
Overall Study NOT COMPLETED	2	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

High Intensity Interval Training in Chronic Stroke

Baseline characteristics by cohort

Measure	High-intensity Interval Training (HIT) n=11 Participants Treadmill exercise using bursts of concentrated effort alternated with recovery periods High-intensity interval training (HIT): Treadmill exercise using bursts of concentrated effort alternated with recovery periods	Traditional Aerobic Training n=5 Participants Moderate intensity continuous aerobic exercise on a treadmill Traditional Aerobic Training: Moderate intensity continuous aerobic exercise on a treadmill	Total n=16 Participants Total of all reporting groups
Age, Continuous	59 years STANDARD_DEVIATION 9 • n=93 Participants	57 years STANDARD_DEVIATION 12 • n=4 Participants	58 years STANDARD_DEVIATION 10 • n=27 Participants
Sex: Female, Male Female	4 Participants n=93 Participants	3 Participants n=4 Participants	7 Participants n=27 Participants
Sex: Female, Male Male	7 Participants n=93 Participants	2 Participants n=4 Participants	9 Participants n=27 Participants
Comfortable gait speed, m/s	0.63 m/s STANDARD_DEVIATION 0.48 • n=93 Participants	0.76 m/s STANDARD_DEVIATION 0.36 • n=4 Participants	0.67 m/s STANDARD_DEVIATION 0.44 • n=27 Participants
Peak oxygen consumption rate, ml/kg/min	16.0 ml/kg/min STANDARD_DEVIATION 4.0 • n=93 Participants	21.6 ml/kg/min STANDARD_DEVIATION 4.0 • n=4 Participants	17.7 ml/kg/min STANDARD_DEVIATION 4.7 • n=27 Participants

PRIMARY outcome

Timeframe: Baseline and 4 weeks

Population: on treatment analysis

Outcome measures

Measure	High-intensity Interval Training (HIT) n=11 Participants Treadmill exercise using bursts of concentrated effort alternated with recovery periods High-intensity interval training (HIT): Treadmill exercise using bursts of concentrated effort alternated with recovery periods	Traditional Aerobic Training n=5 Participants Moderate intensity continuous aerobic exercise on a treadmill Traditional Aerobic Training: Moderate intensity continuous aerobic exercise on a treadmill
Change in Peak Aerobic Capacity (VO2-peak)	2.2 ml/kg/min Interval -0.05 to 4.5	-1.3 ml/kg/min Interval -4.7 to 2.1

SECONDARY outcome

Timeframe: Baseline and 4 weeks

Population: ventilatory threshold was not identifiable for one participant

Outcome measures

Measure	High-intensity Interval Training (HIT) n=10 Participants Treadmill exercise using bursts of concentrated effort alternated with recovery periods High-intensity interval training (HIT): Treadmill exercise using bursts of concentrated effort alternated with recovery periods	Traditional Aerobic Training n=5 Participants Moderate intensity continuous aerobic exercise on a treadmill Traditional Aerobic Training: Moderate intensity continuous aerobic exercise on a treadmill
Change in Submaximal Aerobic Capacity (VO2 at Ventilatory Threshold)	4.4 ml/kg/min Interval 3.1 to 5.7	0.6 ml/kg/min Interval -1.3 to 2.5

SECONDARY outcome

Timeframe: Baseline and 4 weeks

Outcome measures

Measure	High-intensity Interval Training (HIT) n=11 Participants Treadmill exercise using bursts of concentrated effort alternated with recovery periods High-intensity interval training (HIT): Treadmill exercise using bursts of concentrated effort alternated with recovery periods	Traditional Aerobic Training n=5 Participants Moderate intensity continuous aerobic exercise on a treadmill Traditional Aerobic Training: Moderate intensity continuous aerobic exercise on a treadmill
Change in Gait Velocity (10 Meter Walk Test)	0.10 m/s Interval 0.06 to 0.14	0.02 m/s Interval -0.03 to 0.08

SECONDARY outcome

Timeframe: Baseline and 4 weeks

distance walked in 6 minutes

Outcome measures

Measure	High-intensity Interval Training (HIT) n=11 Participants Treadmill exercise using bursts of concentrated effort alternated with recovery periods High-intensity interval training (HIT): Treadmill exercise using bursts of concentrated effort alternated with recovery periods	Traditional Aerobic Training n=5 Participants Moderate intensity continuous aerobic exercise on a treadmill Traditional Aerobic Training: Moderate intensity continuous aerobic exercise on a treadmill
Change in 6-Minute Walk Test	15 meters Interval 1.0 to 29.0	15 meters Interval -6.0 to 36.0

SECONDARY outcome

Timeframe: Baseline and 4 weeks

Population: Subjects with available data

mean oxygen uptake at comfortable walking speed reported in units mLO2 per kilogram body weight per meter

Outcome measures

Measure	High-intensity Interval Training (HIT) n=9 Participants Treadmill exercise using bursts of concentrated effort alternated with recovery periods High-intensity interval training (HIT): Treadmill exercise using bursts of concentrated effort alternated with recovery periods	Traditional Aerobic Training n=5 Participants Moderate intensity continuous aerobic exercise on a treadmill Traditional Aerobic Training: Moderate intensity continuous aerobic exercise on a treadmill
Change in Gait Economy (Mean Oxygen Uptake at Comfortable Walking Speed)	-0.10 mLO2/kg/m Interval -0.17 to -0.03	-0.01 mLO2/kg/m Interval -0.1 to 0.09

SECONDARY outcome

Timeframe: Baseline and 4 weeks

fastest safe treadmill walking speed

Outcome measures

Measure	High-intensity Interval Training (HIT) n=11 Participants Treadmill exercise using bursts of concentrated effort alternated with recovery periods High-intensity interval training (HIT): Treadmill exercise using bursts of concentrated effort alternated with recovery periods	Traditional Aerobic Training n=5 Participants Moderate intensity continuous aerobic exercise on a treadmill Traditional Aerobic Training: Moderate intensity continuous aerobic exercise on a treadmill
Change in Fastest Treadmill Speed (Steep Ramp Test)	0.36 meters per second Interval 0.25 to 0.47	0.07 meters per second Interval -0.1 to 0.24

SECONDARY outcome

Timeframe: Baseline and 4 weeks

Population: Subjects with available data

Metabolic cost of gait as a percentage of aerobic capacity

Outcome measures

Measure	High-intensity Interval Training (HIT) n=8 Participants Treadmill exercise using bursts of concentrated effort alternated with recovery periods High-intensity interval training (HIT): Treadmill exercise using bursts of concentrated effort alternated with recovery periods	Traditional Aerobic Training n=5 Participants Moderate intensity continuous aerobic exercise on a treadmill Traditional Aerobic Training: Moderate intensity continuous aerobic exercise on a treadmill
Change in Fractional Utilization	-36.8 percentage of aerobic capacity Interval -49.3 to -24.3	-8.8 percentage of aerobic capacity Interval -24.7 to -7.0

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline and 4 weeks

Population: Outcome measure not used

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline and 4 weeks

Population: Measure not used

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline and 4 weeks

Population: Measure not used

3D motion capture and force plates

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline and after session 1

Population: measure not used

3D motion capture and force plates

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: During session 1

Population: measure not used

3D motion capture and force plates

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline and 4 weeks

Population: measure not used

Primary variable is motor threshold (MT). Secondary variables include: motor evoked potential amplitude/latency, corticomotor map size and volume and intracortical inhibition

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: Before and after training session 2

Population: measure not used

Primary variable is motor threshold (MT). Secondary variables include: motor evoked potential amplitude/latency and intracortical inhibition

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: Before and after training session 12

Population: measure not used

Primary variable is motor threshold (MT). Secondary variables include: motor evoked potential amplitude/latency and intracortical inhibition

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline and 4 weeks

Population: measure not used

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline and 4 weeks

Cognition Domain Score of Stroke Impact Scale. Scores range from 0 to 100 (higher is better) and represent a sum of scores from multiple questions related to cognition.

Outcome measures

Measure	High-intensity Interval Training (HIT) n=11 Participants Treadmill exercise using bursts of concentrated effort alternated with recovery periods High-intensity interval training (HIT): Treadmill exercise using bursts of concentrated effort alternated with recovery periods	Traditional Aerobic Training n=5 Participants Moderate intensity continuous aerobic exercise on a treadmill Traditional Aerobic Training: Moderate intensity continuous aerobic exercise on a treadmill
Change in Stroke Impact Scale	9.4 units on a scale from 0-100 Standard Deviation 15	0.7 units on a scale from 0-100 Standard Deviation 5.9

Adverse Events

High-intensity Interval Training (HIT)

Serious events: 0 serious events

Other events: 9 other events

Deaths: 0 deaths

Traditional Aerobic Training

Serious events: 0 serious events

Other events: 4 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	High-intensity Interval Training (HIT) n=13 participants at risk Treadmill exercise using bursts of concentrated effort alternated with recovery periods High-intensity interval training (HIT): Treadmill exercise using bursts of concentrated effort alternated with recovery periods	Traditional Aerobic Training n=5 participants at risk Moderate intensity continuous aerobic exercise on a treadmill Traditional Aerobic Training: Moderate intensity continuous aerobic exercise on a treadmill
Musculoskeletal and connective tissue disorders Joint/muscle soreness	53.8% 7/13 • Number of events 10	40.0% 2/5 • Number of events 6
Musculoskeletal and connective tissue disorders Fatigue	30.8% 4/13 • Number of events 4	0.00% 0/5
Vascular disorders Light-headedness	15.4% 2/13 • Number of events 3	0.00% 0/5
Cardiac disorders Atrial fibrillation	7.7% 1/13 • Number of events 2	0.00% 0/5
Musculoskeletal and connective tissue disorders Fall	7.7% 1/13 • Number of events 1	40.0% 2/5 • Number of events 2
Musculoskeletal and connective tissue disorders Other injury	7.7% 1/13 • Number of events 1	0.00% 0/5

Additional Information

Pierce Boyne

University of Cincinnati

Phone: 513-558-7499

Email: Pierce.Boyne@uc.edu

Results disclosure agreements

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