Trial Outcomes & Findings for Hip Osteoarthritis: Effects of Exercise Programs on Pain and Disability (NCT NCT00682617)

Results Overview

Calculated as change from baseline to 3 months

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

41 participants

Primary outcome timeframe

3 months

Results posted on

2020-03-24

Participant Flow

Participant milestones

Participant milestones
Measure	Waitlist Control Waitlist, delayed intervention: Due to limited space in exercise intervention classes, subjects may be placed on a waitlist for 3 months. When an opening becomes available, the subject will begin the exercise program identical to that of Group 2	3 Month Exercise Program Structured exercise program: Exercise intervention will consist of a three-month, supervised, facility-based, hip-specific strengthening, flexibility, and endurance exercise program. The intervention will consist of two phases and take place at OHSU rehabilitation services. Phase 1 will be a two-week orientation and general conditioning program. Phase 2 will be a ten-week progressive workload program. Subjects in both Phase 1 and Phase 2 will meet two to three times per week for 45 minutes per session. Phase 1 will be group sessions with more individualized orientation and attention by the exercise instructors. Phase 2 will begin progressive conditioning and utilize exercise groups of four to six subjects.
Overall Study STARTED	13	28
Overall Study COMPLETED	10	21
Overall Study NOT COMPLETED	3	7

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Hip Osteoarthritis: Effects of Exercise Programs on Pain and Disability

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Waitlist Control n=10 Participants Waitlist, delayed intervention: Due to limited space in exercise intervention classes, subjects may be placed on a waitlist for 3 months. When an opening becomes available, the subject will begin the exercise program identical to that of Group 2	3 Month Exercise Program n=21 Participants Structured exercise program: Exercise intervention will consist of a three-month, supervised, facility-based, hip-specific strengthening, flexibility, and endurance exercise program. The intervention will consist of two phases and take place at OHSU rehabilitation services. Phase 1 will be a two-week orientation and general conditioning program. Phase 2 will be a ten-week progressive workload program. Subjects in both Phase 1 and Phase 2 will meet two to three times per week for 45 minutes per session. Phase 1 will be group sessions with more individualized orientation and attention by the exercise instructors. Phase 2 will begin progressive conditioning and utilize exercise groups of four to six subjects.	Total n=31 Participants Total of all reporting groups
Age, Continuous	60.8 years STANDARD_DEVIATION 9.1 • n=5 Participants	59.7 years STANDARD_DEVIATION 8.7 • n=7 Participants	60.1 years STANDARD_DEVIATION 8.7 • n=5 Participants
Sex: Female, Male Female	7 Participants n=5 Participants	9 Participants n=7 Participants	16 Participants n=5 Participants
Sex: Female, Male Male	3 Participants n=5 Participants	12 Participants n=7 Participants	15 Participants n=5 Participants
6 Minute Walk Test	538 meters n=5 Participants	567 meters n=7 Participants	562 meters n=5 Participants
WOMAC Physical Function Subscale	21 units on a scale n=5 Participants	22 units on a scale n=7 Participants	21 units on a scale n=5 Participants
Pain Visual Analog Scale	37 units on a scale n=5 Participants	37 units on a scale n=7 Participants	37 units on a scale n=5 Participants

PRIMARY outcome

Timeframe: 3 months

Calculated as change from baseline to 3 months

Outcome measures

Outcome measures
Measure	Waitlist Control n=10 Participants Waitlist, delayed intervention: Due to limited space in exercise intervention classes, subjects may be placed on a waitlist for 3 months. When an opening becomes available, the subject will begin the exercise program identical to that of Group 2	3 Month Exercise Program n=21 Participants Structured exercise program: Exercise intervention will consist of a three-month, supervised, facility-based, hip-specific strengthening, flexibility, and endurance exercise program. The intervention will consist of two phases and take place at OHSU rehabilitation services. Phase 1 will be a two-week orientation and general conditioning program. Phase 2 will be a ten-week progressive workload program. Subjects in both Phase 1 and Phase 2 will meet two to three times per week for 45 minutes per session. Phase 1 will be group sessions with more individualized orientation and attention by the exercise instructors. Phase 2 will begin progressive conditioning and utilize exercise groups of four to six subjects.
Change in 6-minute Walk Test	22 meters Interval -10.0 to 64.0	49 meters Interval 24.0 to 83.0

SECONDARY outcome

Timeframe: 3 months

Evaluated using a 100mm pain VAS (range 0-100), with higher scores indicating worse pain. Calculated as change from baseline to 3 months.

Outcome measures

Outcome measures
Measure	Waitlist Control n=10 Participants Waitlist, delayed intervention: Due to limited space in exercise intervention classes, subjects may be placed on a waitlist for 3 months. When an opening becomes available, the subject will begin the exercise program identical to that of Group 2	3 Month Exercise Program n=21 Participants Structured exercise program: Exercise intervention will consist of a three-month, supervised, facility-based, hip-specific strengthening, flexibility, and endurance exercise program. The intervention will consist of two phases and take place at OHSU rehabilitation services. Phase 1 will be a two-week orientation and general conditioning program. Phase 2 will be a ten-week progressive workload program. Subjects in both Phase 1 and Phase 2 will meet two to three times per week for 45 minutes per session. Phase 1 will be group sessions with more individualized orientation and attention by the exercise instructors. Phase 2 will begin progressive conditioning and utilize exercise groups of four to six subjects.
Change in Pain Visual Analog Scale	-3 units on a scale Interval -14.0 to 1.0	-5 units on a scale Interval -19.0 to -1.0

SECONDARY outcome

Timeframe: 3 months

The WOMAC Physical Function Subscale has a range of 0-68, with higher scores indicating worse functional limitations. Calculated as change from baseline to 3 months.

Outcome measures

Outcome measures
Measure	Waitlist Control n=10 Participants Waitlist, delayed intervention: Due to limited space in exercise intervention classes, subjects may be placed on a waitlist for 3 months. When an opening becomes available, the subject will begin the exercise program identical to that of Group 2	3 Month Exercise Program n=21 Participants Structured exercise program: Exercise intervention will consist of a three-month, supervised, facility-based, hip-specific strengthening, flexibility, and endurance exercise program. The intervention will consist of two phases and take place at OHSU rehabilitation services. Phase 1 will be a two-week orientation and general conditioning program. Phase 2 will be a ten-week progressive workload program. Subjects in both Phase 1 and Phase 2 will meet two to three times per week for 45 minutes per session. Phase 1 will be group sessions with more individualized orientation and attention by the exercise instructors. Phase 2 will begin progressive conditioning and utilize exercise groups of four to six subjects.
Change in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale	-2 units on a scale Interval -4.0 to 2.0	-5 units on a scale Interval -9.0 to -2.0

Adverse Events

Waitlist Control

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

3 Month Exercise Program

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. Nels Carlson

Oregon Health & Science University

Phone: (503) 494-6420

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place