Trial Outcomes & Findings for Assessment of Efficacy of Low Intensity Resistance Training in Women at Risk for Symptomatic Knee Osteoarthritis (NCT NCT01440972)

NCT ID: NCT01440972

Last Updated: 2016-12-05

Results Overview

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 45 participants
• Primary outcome timeframe: 4 weeks
• Results posted on: 2016-12-05

Participant Flow

Participant milestones

Measure	Exercise Without PBFR low intensity resistance training: low intensity resistance training without partial blood flow restriction	Exercise With PBFR partial blood flow restriction (PBFR): low intensity resistance training with partial blood flow restriction 3 times/week for 4 weeks.
Overall Study STARTED	24	21
Overall Study COMPLETED	21	19
Overall Study NOT COMPLETED	3	2

Reasons for withdrawal

Measure	Exercise Without PBFR low intensity resistance training: low intensity resistance training without partial blood flow restriction	Exercise With PBFR partial blood flow restriction (PBFR): low intensity resistance training with partial blood flow restriction 3 times/week for 4 weeks.
Overall Study Withdrawal by Subject	3	2

Baseline Characteristics

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

Baseline characteristics by cohort

Measure	Exercise Without PBFR n=21 Participants low intensity resistance training: low intensity resistance training without partial blood flow restriction	Exercise With PBFR n=19 Participants partial blood flow restriction (PBFR): low intensity resistance training with partial blood flow restriction 3 times/week for 4 weeks.	Total n=40 Participants Total of all reporting groups
Age, Continuous	54.6 years STANDARD_DEVIATION 6.9 • n=5 Participants	56.1 years STANDARD_DEVIATION 5.9 • n=7 Participants	55.4 years STANDARD_DEVIATION 6.5 • n=5 Participants
Gender Female	21 Participants n=5 Participants	19 Participants n=7 Participants	40 Participants n=5 Participants
Gender Male	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants

PRIMARY outcome

Timeframe: 4 weeks

Outcome measures

Measure	Exercise Without PBFR n=21 Participants low intensity resistance training: low intensity resistance training without partial blood flow restriction	Exercise With PBFR n=19 Participants partial blood flow restriction (PBFR): low intensity resistance training with partial blood flow restriction 3 times/week for 4 weeks.
Change in Isotonic Double Leg-press 1 Repetition Maximum Strength Scaled to Body Mass	0.2 kg per kg body mass Standard Deviation 0.3	0.4 kg per kg body mass Standard Deviation 0.3

SECONDARY outcome

Timeframe: 4 weeks

Outcome measures

Measure	Exercise Without PBFR n=21 Participants low intensity resistance training: low intensity resistance training without partial blood flow restriction	Exercise With PBFR n=19 Participants partial blood flow restriction (PBFR): low intensity resistance training with partial blood flow restriction 3 times/week for 4 weeks.
Change in Quadriceps Muscle Volume by Magnetic Resonance Imaging	0.01 Percent change Standard Deviation .73	1.3 Percent change Standard Deviation 0.80

SECONDARY outcome

Timeframe: 4 weeks

Outcome measures

Measure	Exercise Without PBFR n=21 Participants low intensity resistance training: low intensity resistance training without partial blood flow restriction	Exercise With PBFR n=19 Participants partial blood flow restriction (PBFR): low intensity resistance training with partial blood flow restriction 3 times/week for 4 weeks.
Change in Lower Limb Muscle Power by Double Leg-press at 40% 1 Repetition Maximum	0.42 Watts Standard Deviation .26	.62 Watts Standard Deviation .27

SECONDARY outcome

Timeframe: 4 weeks

KOOS consists of 5 subscales; Pain, other Symptoms, Function in daily living (ADL), Function in sport and recreation (Sport/Rec) and knee related Quality of life QOL. The last week is taken into consideration when answering the questions. Standardized answer options are given (5 Likert boxes) and each question gets a score from 0 to 4. A normalized score (100 indicating no symptoms and 0 indicating extreme symptoms) is calculated for each subscale. KOOS is patient-administered, the format is user friendly, and takes about 10 minutes to fill out. Only the pain sub scale was used for the reported study.

Outcome measures

Measure	Exercise Without PBFR n=21 Participants low intensity resistance training: low intensity resistance training without partial blood flow restriction	Exercise With PBFR n=19 Participants partial blood flow restriction (PBFR): low intensity resistance training with partial blood flow restriction 3 times/week for 4 weeks.
Change in Knee Injury and Osteoarthritis Outcome Score Pain Subscale	1.8 units on a scale Standard Deviation 2.7	2.0 units on a scale Standard Deviation 2.8

SECONDARY outcome

Timeframe: 4 weeks

Outcome measures

Measure	Exercise Without PBFR n=21 Participants low intensity resistance training: low intensity resistance training without partial blood flow restriction	Exercise With PBFR n=19 Participants partial blood flow restriction (PBFR): low intensity resistance training with partial blood flow restriction 3 times/week for 4 weeks.
Change in Isokinetic Knee Extensor Strength	-0.05 Nm/kg Standard Error 0.03	.07 Nm/kg Standard Error .03

Adverse Events

Exercise Without PBFR

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Exercise With 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