Trial Outcomes & Findings for Feasibility of High Intensity Interval Training in Knee Osteoarthritis (NCT NCT03281668)

NCT ID: NCT03281668

Last Updated: 2019-11-22

Results Overview

Number of participants screened and enrolled divided by the total number of participants screened

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 29 participants
• Primary outcome timeframe: Baseline
• Results posted on: 2019-11-22

Participant Flow

Participant milestones

Measure	Intervention Intervention consists of High Intensity Interval Training (HIIT) session which is af 3-5 minute warm up, followed by 10 repetitions of 1 minute bouts at individualized training intensity with 1 minute rest periods. High intensity interval training (HIIT): Each training session for High Intensity Interval Training will consist of a 3-5 minute warm-up, followed by 10 repetitions of 1-minute bouts at individualized training intensity with 1-minute rest periods.
Overall Study STARTED	29
Overall Study COMPLETED	21
Overall Study NOT COMPLETED	8

Reasons for withdrawal

Measure	Intervention Intervention consists of High Intensity Interval Training (HIIT) session which is af 3-5 minute warm up, followed by 10 repetitions of 1 minute bouts at individualized training intensity with 1 minute rest periods. High intensity interval training (HIIT): Each training session for High Intensity Interval Training will consist of a 3-5 minute warm-up, followed by 10 repetitions of 1-minute bouts at individualized training intensity with 1-minute rest periods.
Overall Study Physician Decision	1
Overall Study scheduling conflict, family circumstance	2
Overall Study Withdrawal by Subject	4
Overall Study Lost to Follow-up	1

Baseline Characteristics

Feasibility of High Intensity Interval Training in Knee Osteoarthritis

Baseline characteristics by cohort

Measure	Intervention n=29 Participants Intervention consists of High Intensity Interval Training (HIIT) session which is af 3-5 minute warm up, followed by 10 repetitions of 1 minute bouts at individualized training intensity with 1 minute rest periods. High intensity interval training (HIIT): Each training session for High Intensity Interval Training will consist of a 3-5 minute warm-up, followed by 10 repetitions of 1-minute bouts at individualized training intensity with 1-minute rest periods.
Age, Continuous	63 years n=93 Participants
Sex: Female, Male Female	19 Participants n=93 Participants
Sex: Female, Male Male	10 Participants n=93 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	2 Participants n=93 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	27 Participants n=93 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=93 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=93 Participants
Race (NIH/OMB) Asian	1 Participants n=93 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=93 Participants
Race (NIH/OMB) Black or African American	7 Participants n=93 Participants
Race (NIH/OMB) White	20 Participants n=93 Participants
Race (NIH/OMB) More than one race	0 Participants n=93 Participants
Race (NIH/OMB) Unknown or Not Reported	1 Participants n=93 Participants
Region of Enrollment United States	29 Participants n=93 Participants
BMI	31.8 kg/m^2 STANDARD_DEVIATION 6.5 • n=93 Participants

PRIMARY outcome

Timeframe: Baseline

Number of participants screened and enrolled divided by the total number of participants screened

Outcome measures

Measure

Intervention n=150 Participants Intervention consists of High Intensity Interval Training (HIIT) session which is a 3-5 minute warm up, followed by 10 repetitions of 1 minute bouts at individualized training intensity with 1 minute rest periods. High intensity interval training (HIIT): Each training session for High Intensity Interval Training will consist of a 3-5 minute warm-up, followed by 10 repetitions of 1-minute bouts at individualized training intensity with 1-minute rest periods.

Percent of Potential Participants Screened for the Study Who Are Enrolled

19.3 percentage of participants

PRIMARY outcome

Timeframe: Study completion (12 weeks)

Number of participants who completed the study (baseline through 12 week assessments) divided by the total number of enrolled participants with baseline assessments

Outcome measures

Measure

Intervention n=29 Participants Intervention consists of High Intensity Interval Training (HIIT) session which is a 3-5 minute warm up, followed by 10 repetitions of 1 minute bouts at individualized training intensity with 1 minute rest periods. High intensity interval training (HIIT): Each training session for High Intensity Interval Training will consist of a 3-5 minute warm-up, followed by 10 repetitions of 1-minute bouts at individualized training intensity with 1-minute rest periods.

Percentage of Enrolled Participants Retained at the End of the Study

72.4 percentage of participants

SECONDARY outcome

Timeframe: Weekly measures for 12 consecutive weeks

Up to 2 training sessions were possible each week over the 12 week intervention

Outcome measures

Measure

Intervention n=29 Participants Intervention consists of High Intensity Interval Training (HIIT) session which is a 3-5 minute warm up, followed by 10 repetitions of 1 minute bouts at individualized training intensity with 1 minute rest periods. High intensity interval training (HIIT): Each training session for High Intensity Interval Training will consist of a 3-5 minute warm-up, followed by 10 repetitions of 1-minute bouts at individualized training intensity with 1-minute rest periods.

Average Number of Training Sessions Completed Per Week

1.9 training sessions per week Standard Deviation 0.24

SECONDARY outcome

Timeframe: 12 weeks

Total number of training sessions completed out of up to 24 sessions (2 per week over 12 weeks)

Outcome measures

Measure

Intervention n=29 Participants Intervention consists of High Intensity Interval Training (HIIT) session which is a 3-5 minute warm up, followed by 10 repetitions of 1 minute bouts at individualized training intensity with 1 minute rest periods. High intensity interval training (HIIT): Each training session for High Intensity Interval Training will consist of a 3-5 minute warm-up, followed by 10 repetitions of 1-minute bouts at individualized training intensity with 1-minute rest periods.

Total Number of Training Sessions Completed

19.4 training sessions Standard Deviation 7.4

SECONDARY outcome

Timeframe: 12 weeks

Total number of training weeks (up to 12 weeks possible)

Outcome measures

Measure

Intervention n=29 Participants Intervention consists of High Intensity Interval Training (HIIT) session which is a 3-5 minute warm up, followed by 10 repetitions of 1 minute bouts at individualized training intensity with 1 minute rest periods. High intensity interval training (HIIT): Each training session for High Intensity Interval Training will consist of a 3-5 minute warm-up, followed by 10 repetitions of 1-minute bouts at individualized training intensity with 1-minute rest periods.

Total Number of Training Weeks Completed

11.4 weeks Standard Deviation 1.47

SECONDARY outcome

Timeframe: Baseline,12 weeks

The WOMAC, a measure of lower extremity pain (5 items), stiffness (2 items), and function (17 items), will be used to measure overall symptomatic burden of knee osteoarthritis (OA). Each item is scored from 0-4 (none, slight, moderate, severe, and extreme). Items are added to calculate a total WOMAC score ranging from 0 (no problems) to 96 (extreme problems). A higher score means a worse outcome.

Outcome measures

Measure

Intervention n=21 Participants Intervention consists of High Intensity Interval Training (HIIT) session which is a 3-5 minute warm up, followed by 10 repetitions of 1 minute bouts at individualized training intensity with 1 minute rest periods. High intensity interval training (HIIT): Each training session for High Intensity Interval Training will consist of a 3-5 minute warm-up, followed by 10 repetitions of 1-minute bouts at individualized training intensity with 1-minute rest periods.

Change in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Total Score From Baseline to 12 Weeks

-9.2 percentage change in score Interval -13.6 to -4.9

SECONDARY outcome

Timeframe: Baseline,12 weeks

The WOMAC pain subscale contains 5 items about knee pain. Each item is scored from 0-4 (none, slight, moderate, severe, and extreme). Items are added to calculate a WOMAC pain score ranging from 0 (no pain) to 20 (extreme pain). A higher score means more severe pain.

Outcome measures

Measure

Intervention n=21 Participants Intervention consists of High Intensity Interval Training (HIIT) session which is a 3-5 minute warm up, followed by 10 repetitions of 1 minute bouts at individualized training intensity with 1 minute rest periods. High intensity interval training (HIIT): Each training session for High Intensity Interval Training will consist of a 3-5 minute warm-up, followed by 10 repetitions of 1-minute bouts at individualized training intensity with 1-minute rest periods.

Change in WOMAC Pain Subscale From Baseline to 12 Weeks

-1.7 percentage change in score Interval -2.8 to -0.6

SECONDARY outcome

Timeframe: Baseline, 12 weeks

The WOMAC function subscale contains 17 items about knee function during daily activities. Each item is scored from 0-4 (none, slight, moderate, severe, and extreme). Items are added to calculate a WOMAC pain score ranging from 0 (no problems with function) to 68 (extreme problems with function). A higher score means worse function.

Outcome measures

Measure

Intervention n=21 Participants Intervention consists of High Intensity Interval Training (HIIT) session which is a 3-5 minute warm up, followed by 10 repetitions of 1 minute bouts at individualized training intensity with 1 minute rest periods. High intensity interval training (HIIT): Each training session for High Intensity Interval Training will consist of a 3-5 minute warm-up, followed by 10 repetitions of 1-minute bouts at individualized training intensity with 1-minute rest periods.

Change in WOMAC Function Subscale From Baseline to 12 Weeks

-6.3 percentage change in score Interval -9.6 to -3.1

SECONDARY outcome

Timeframe: Baseline, 12 weeks

Population: Originally planned to have participants perform 40-meter walk; however, due to lab space constraints, this was altered to a 20-meter walk instead.

Measure of the ability to walk quickly over short distances. Participants walk at fast pace that is timed over 2 x 10m.

Outcome measures

Measure

Intervention n=21 Participants Intervention consists of High Intensity Interval Training (HIIT) session which is a 3-5 minute warm up, followed by 10 repetitions of 1 minute bouts at individualized training intensity with 1 minute rest periods. High intensity interval training (HIIT): Each training session for High Intensity Interval Training will consist of a 3-5 minute warm-up, followed by 10 repetitions of 1-minute bouts at individualized training intensity with 1-minute rest periods.

Change in 20m Fast Paced Walk Test

-1.13 seconds Interval -1.61 to -0.64

SECONDARY outcome

Timeframe: Baseline, 12 weeks

Number of chair stand repetitions completed in 30 seconds

Outcome measures

Measure

Intervention n=21 Participants Intervention consists of High Intensity Interval Training (HIIT) session which is a 3-5 minute warm up, followed by 10 repetitions of 1 minute bouts at individualized training intensity with 1 minute rest periods. High intensity interval training (HIIT): Each training session for High Intensity Interval Training will consist of a 3-5 minute warm-up, followed by 10 repetitions of 1-minute bouts at individualized training intensity with 1-minute rest periods.

Change in Number of Chair Stand Repetitions Completed

2.6 number of chair stands Interval 1.8 to 3.4

SECONDARY outcome

Timeframe: Baseline, 12 weeks

Time in seconds to ascend and descend a flight of stairs

Outcome measures

Measure

Intervention n=21 Participants Intervention consists of High Intensity Interval Training (HIIT) session which is a 3-5 minute warm up, followed by 10 repetitions of 1 minute bouts at individualized training intensity with 1 minute rest periods. High intensity interval training (HIIT): Each training session for High Intensity Interval Training will consist of a 3-5 minute warm-up, followed by 10 repetitions of 1-minute bouts at individualized training intensity with 1-minute rest periods.

Change in Stair Climb Test

-1.42 change in seconds Interval -2.13 to -0.71

SECONDARY outcome

Timeframe: Baseline, 12 weeks

Time in seconds to rise from a chair, walk 3 m, turn, walk back to chair, and sit down

Outcome measures

Measure

Intervention n=21 Participants Intervention consists of High Intensity Interval Training (HIIT) session which is a 3-5 minute warm up, followed by 10 repetitions of 1 minute bouts at individualized training intensity with 1 minute rest periods. High intensity interval training (HIIT): Each training session for High Intensity Interval Training will consist of a 3-5 minute warm-up, followed by 10 repetitions of 1-minute bouts at individualized training intensity with 1-minute rest periods.

Change in Timed Up and Go

-0.58 change in seconds Interval -0.95 to -0.22

SECONDARY outcome

Timeframe: Baseline, 12 weeks

Population: All participants were able to complete Feet Together Stand at baseline and 12 weeks (no change).

Feet together stand for up to 10 seconds without assistive device

Outcome measures

Measure

Intervention n=21 Participants Intervention consists of High Intensity Interval Training (HIIT) session which is a 3-5 minute warm up, followed by 10 repetitions of 1 minute bouts at individualized training intensity with 1 minute rest periods. High intensity interval training (HIIT): Each training session for High Intensity Interval Training will consist of a 3-5 minute warm-up, followed by 10 repetitions of 1-minute bouts at individualized training intensity with 1-minute rest periods.

Change in Feet Together Stand

0.00 change in seconds Interval 0.0 to 0.0

SECONDARY outcome

Timeframe: Baseline, 12 weeks

Heel of one foot placed to the side of the big toe of the other foot, for up to 10 seconds

Outcome measures

Measure

Intervention n=21 Participants Intervention consists of High Intensity Interval Training (HIIT) session which is a 3-5 minute warm up, followed by 10 repetitions of 1 minute bouts at individualized training intensity with 1 minute rest periods. High intensity interval training (HIIT): Each training session for High Intensity Interval Training will consist of a 3-5 minute warm-up, followed by 10 repetitions of 1-minute bouts at individualized training intensity with 1-minute rest periods.

Change in Semi-tandem Stand

0.52 change in seconds Interval -0.18 to 1.23

SECONDARY outcome

Timeframe: Baseline, 12 weeks

One foot in front of the other, heel touching toe, for up to 10 seconds

Outcome measures

Measure

Intervention n=21 Participants Intervention consists of High Intensity Interval Training (HIIT) session which is a 3-5 minute warm up, followed by 10 repetitions of 1 minute bouts at individualized training intensity with 1 minute rest periods. High intensity interval training (HIIT): Each training session for High Intensity Interval Training will consist of a 3-5 minute warm-up, followed by 10 repetitions of 1-minute bouts at individualized training intensity with 1-minute rest periods.

Change in Tandem Stand

0.39 change in seconds Interval -0.33 to 1.11

SECONDARY outcome

Timeframe: Baseline, 12 weeks

One leg stand for up to 30 seconds

Outcome measures

Measure

Intervention n=21 Participants Intervention consists of High Intensity Interval Training (HIIT) session which is a 3-5 minute warm up, followed by 10 repetitions of 1 minute bouts at individualized training intensity with 1 minute rest periods. High intensity interval training (HIIT): Each training session for High Intensity Interval Training will consist of a 3-5 minute warm-up, followed by 10 repetitions of 1-minute bouts at individualized training intensity with 1-minute rest periods.

Change in One Leg Stand

3.41 change in seconds Interval 0.26 to 6.56

SECONDARY outcome

Timeframe: Baseline, 12 weeks

Measure by peak oxygen consumption (VO2peak),to identify fitness level and evaluate cardiovascular effects. Test will establish individual training intensity.

Outcome measures

Measure

Intervention n=21 Participants Intervention consists of High Intensity Interval Training (HIIT) session which is a 3-5 minute warm up, followed by 10 repetitions of 1 minute bouts at individualized training intensity with 1 minute rest periods. High intensity interval training (HIIT): Each training session for High Intensity Interval Training will consist of a 3-5 minute warm-up, followed by 10 repetitions of 1-minute bouts at individualized training intensity with 1-minute rest periods.

Change in Cardiorespiratory Fitness

0.14 change in liters/minute Interval 0.03 to 0.24

SECONDARY outcome

Timeframe: Baseline, 12 weeks

fat mass in kilograms, measured with dual energy x-ray absorptiometry (DXA)

Outcome measures

Measure

Intervention n=21 Participants Intervention consists of High Intensity Interval Training (HIIT) session which is a 3-5 minute warm up, followed by 10 repetitions of 1 minute bouts at individualized training intensity with 1 minute rest periods. High intensity interval training (HIIT): Each training session for High Intensity Interval Training will consist of a 3-5 minute warm-up, followed by 10 repetitions of 1-minute bouts at individualized training intensity with 1-minute rest periods.

Change in Whole Body Fat Mass

-0.28 kilogram (kg) Interval -1.1 to 0.54

SECONDARY outcome

Timeframe: Baseline, 12 weeks

lean body mass in kilograms, measured with DXA

Outcome measures

Measure

Intervention n=21 Participants Intervention consists of High Intensity Interval Training (HIIT) session which is a 3-5 minute warm up, followed by 10 repetitions of 1 minute bouts at individualized training intensity with 1 minute rest periods. High intensity interval training (HIIT): Each training session for High Intensity Interval Training will consist of a 3-5 minute warm-up, followed by 10 repetitions of 1-minute bouts at individualized training intensity with 1-minute rest periods.

Change in Lean Body Mass

-0.12 kilogram (kg) Interval -0.56 to 0.31

SECONDARY outcome

Timeframe: Baseline, 12 weeks

visceral fat in kilograms, measured with DXA

Outcome measures

Measure

Intervention n=21 Participants Intervention consists of High Intensity Interval Training (HIIT) session which is a 3-5 minute warm up, followed by 10 repetitions of 1 minute bouts at individualized training intensity with 1 minute rest periods. High intensity interval training (HIIT): Each training session for High Intensity Interval Training will consist of a 3-5 minute warm-up, followed by 10 repetitions of 1-minute bouts at individualized training intensity with 1-minute rest periods.

Change in Visceral Fat

-0.19 kilogram (kg) Interval -0.4 to 0.02

SECONDARY outcome

Timeframe: Baseline, 12 weeks

Humac isokinetic dynamometer to measure isokinetic power and isometric strength of knee flexors extensors

Outcome measures

Measure	Intervention n=21 Participants Intervention consists of High Intensity Interval Training (HIIT) session which is a 3-5 minute warm up, followed by 10 repetitions of 1 minute bouts at individualized training intensity with 1 minute rest periods. High intensity interval training (HIIT): Each training session for High Intensity Interval Training will consist of a 3-5 minute warm-up, followed by 10 repetitions of 1-minute bouts at individualized training intensity with 1-minute rest periods.
Change in Knee Strength Right knee flexors	3.34 change in maximum kilograms Interval -0.74 to 7.41
Change in Knee Strength Left knee flexors	-0.84 change in maximum kilograms Interval -6.36 to 4.69
Change in Knee Strength Right knee extensors	9.99 change in maximum kilograms Interval 1.8 to 18.18
Change in Knee Strength Left knee extensors	9.86 change in maximum kilograms Interval 0.4 to 19.33

Adverse Events

Intervention

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Yvonne Golightly, PhD

University of North Carolina at Chapel Hill/Thurston Arthritis Research Center

Phone: 919-966-0566

Email: golight@email.unc.edu

Results disclosure agreements

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