Trial Outcomes & Findings for Exercise Intervention to Reduce Postural Instability in Osteoarthritis (NCT NCT00708734)

NCT ID: NCT00708734

Last Updated: 2014-10-23

Results Overview

Assessment of balance using the (sensory organization test, limits of stability, berg balance) and gait using 3D motion capture.

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 10 participants
• Primary outcome timeframe: 5 months
• Results posted on: 2014-10-23

Participant Flow

Participant milestones

Measure	Arm 1 functional exercise training functional exercise training: twice weekly group sessions for 10 weeks This one year feasibility study had a planned sample of 35 subjects. Of the 94 subjects that were screened, 45 did not meet criteria, and 39 declined participation after screening. Of the ten subjects enrolled, three completed the intervention and follow up sessions. The remaining seven were unable to continue participation after enrollment due to a number or reasons including vertigo, moving out of state, total knee replacement after baseline, unable to contact, scheduling conflicts, and a fall with fracture, precluding weight-bearing exercise.
Overall Study STARTED	10
Overall Study COMPLETED	3
Overall Study NOT COMPLETED	7

Reasons for withdrawal

Measure	Arm 1 functional exercise training functional exercise training: twice weekly group sessions for 10 weeks This one year feasibility study had a planned sample of 35 subjects. Of the 94 subjects that were screened, 45 did not meet criteria, and 39 declined participation after screening. Of the ten subjects enrolled, three completed the intervention and follow up sessions. The remaining seven were unable to continue participation after enrollment due to a number or reasons including vertigo, moving out of state, total knee replacement after baseline, unable to contact, scheduling conflicts, and a fall with fracture, precluding weight-bearing exercise.
Overall Study scheduling conflict	2
Overall Study moved	1
Overall Study leg injury	1
Overall Study knee replacement	1
Overall Study vertigo	1
Overall Study leg fracture	1

Baseline Characteristics

Exercise Intervention to Reduce Postural Instability in Osteoarthritis

Baseline characteristics by cohort

Measure	Functional Exercise Training n=10 Participants functional exercise training functional exercise training: twice weekly group sessions for 5 weeks
Age, Continuous	66.5 years n=5 Participants
Sex: Female, Male Female	1 Participants n=5 Participants
Sex: Female, Male Male	9 Participants n=5 Participants

PRIMARY outcome

Timeframe: 5 months

Population: The purpose of this pilot study was to evaluate the feasibilty of a structured, group exercise program in this population. Only 3 of 10 participants completed the study, due to high attrition, the project was considered unfeasible and data was not analysis.

Assessment of balance using the (sensory organization test, limits of stability, berg balance) and gait using 3D motion capture.

Outcome measures

Outcome data not reported

Adverse Events

Functional Exercise Training

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

Tatjana Bulat

Tampa VA Hospital

Phone: 8135583932

Email: tatjana.bulat@va.gov

Results disclosure agreements

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