Trial Outcomes & Findings for Assessment of Efficacy of Low Intensity Resistance Training in Men at Risk for Symptomatic Knee Osteoarthritis (NCT NCT01487525)

NCT ID: NCT01487525

Last Updated: 2016-02-04

Results Overview

double leg press 1 rep maximum strength

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 44 participants
• Primary outcome timeframe: 0,6 weeks
• Results posted on: 2016-02-04

Participant Flow

44 subjects were enrolled. Prior to starting the study, 2 participants dropped out due to lack of time. Since they discontinued after consent, but prior to any measurements or interventions, no data is available for these 2. Data is available for the 42 subjects who started the study.

Participant milestones

Measure	PBFR- strength training exercise without partial blood flow restriction double leg press without partial blood flow restriction: double leg press extension without application of partial blood flow restriction to the upper leg	PBFR+ strength training exercise with partial blood flow restriction double leg press with partial blood flow restriction: double leg press extension with application of partial blood flow restriction to the upper leg
Overall Study STARTED	22	20
Overall Study COMPLETED	22	19
Overall Study NOT COMPLETED	0	1

Reasons for withdrawal

Measure	PBFR- strength training exercise without partial blood flow restriction double leg press without partial blood flow restriction: double leg press extension without application of partial blood flow restriction to the upper leg	PBFR+ strength training exercise with partial blood flow restriction double leg press with partial blood flow restriction: double leg press extension with application of partial blood flow restriction to the upper leg
Overall Study Withdrawal by Subject	0	1

Baseline Characteristics

Assessment of Efficacy of Low Intensity Resistance Training in Men at Risk for Symptomatic Knee Osteoarthritis

Baseline characteristics by cohort

Measure	PBFR- n=22 Participants strength training exercise without partial blood flow restriction double leg press without partial blood flow restriction: double leg press extension without application of partial blood flow restriction to the upper leg	PBFR+ n=20 Participants strength training exercise with partial blood flow restriction double leg press with partial blood flow restriction: double leg press extension with application of partial blood flow restriction to the upper leg	Total n=42 Participants Total of all reporting groups
Sex: Female, Male Female	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Sex: Female, Male Male	22 Participants n=5 Participants	20 Participants n=7 Participants	42 Participants n=5 Participants
Region of Enrollment United States	22 participants n=5 Participants	20 participants n=7 Participants	42 participants n=5 Participants
Age, Continuous	56.1 years STANDARD_DEVIATION 7.7 • n=5 Participants	58.4 years STANDARD_DEVIATION 8.7 • n=7 Participants	57.2 years STANDARD_DEVIATION 5.8 • n=5 Participants

PRIMARY outcome

Timeframe: 0,6 weeks

double leg press 1 rep maximum strength

Outcome measures

Measure	PBFR- n=22 Participants strength training exercise without partial blood flow restriction double leg press without partial blood flow restriction: double leg press extension without application of partial blood flow restriction to the upper leg	PBFR+ n=19 Participants strength training exercise with partial blood flow restriction double leg press with partial blood flow restriction: double leg press extension with application of partial blood flow restriction to the upper leg
Change in Isotonic Leg Press 1RM	4.7 percent change Standard Deviation 1.3	3.1 percent change Standard Deviation 0.9

SECONDARY outcome

Timeframe: 0, 6 weeks

Outcome measures

Measure	PBFR- n=22 Participants strength training exercise without partial blood flow restriction double leg press without partial blood flow restriction: double leg press extension without application of partial blood flow restriction to the upper leg	PBFR+ n=19 Participants strength training exercise with partial blood flow restriction double leg press with partial blood flow restriction: double leg press extension with application of partial blood flow restriction to the upper leg
Isokinetic Knee Extensor Strength	6.7 percent change Standard Error 2.3	0.4 percent change Standard Error 2.4

SECONDARY outcome

Timeframe: 0, 6 weeks

Knee injury and Osteoarthritis Outcome Score (KOOS) questionnaire Pain Sub-Scale (0-100); larger absolute values represent less pain; a positive % changes indicates a reduction in pain

Outcome measures

Measure	PBFR- n=22 Participants strength training exercise without partial blood flow restriction double leg press without partial blood flow restriction: double leg press extension without application of partial blood flow restriction to the upper leg	PBFR+ n=19 Participants strength training exercise with partial blood flow restriction double leg press with partial blood flow restriction: double leg press extension with application of partial blood flow restriction to the upper leg
Knee Pain	14.2 Percent change Standard Deviation 7.2	4.9 Percent change Standard Deviation 3.3

Adverse Events

PBFR-

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

PBFR+

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

Dr. Neil Segal

University of Iowa

Phone: 3193358204

Email: segal-research@uiowa.edu

Results disclosure agreements

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