Trial Outcomes & Findings for Mobility Optimization Through Velocity Exercise (NCT NCT00844558)

Results Overview

This is a questionnaire that evaluates self-reported difficulty in a person's ability to do discrete actions or activities primarily involving standing, stooping and fundamental walking activities without the help of others. Factors that may influence difficulty in task performance include pain, fatigue, fear, weakness, soreness, ailments, health conditions and disabilities. Scored from 14 to 70 with scores approaching 70 signifying high levels in ability to perform activities primarily involving standing, stooping, and fundamental walking (without assistance), and scores approaching 14 signifying low levels in ability to perform activities primarily involving standing, stooping, and fundamental walking (without assistance).

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

58 participants

Primary outcome timeframe

0,3,6, and 12 months

Results posted on

2016-06-06

Participant Flow

Participant milestones

Participant milestones
Measure	Gait Gait Training Arm Gait Training: Gait training with a physical therapist 2/week for the first 3 months followed by 1/week for the following 3 months	Control Control Group Control: There is no intervention associated with this arm of the study
Overall Study STARTED	36	22
Overall Study Received Allocated Intervention	33	21
Overall Study 3 Month Visit	29	19
Overall Study 6 Month Visit	28	18
Overall Study 12 Month Visit	24	18
Overall Study COMPLETED	24	18
Overall Study NOT COMPLETED	12	4

Reasons for withdrawal

Reasons for withdrawal
Measure	Gait Gait Training Arm Gait Training: Gait training with a physical therapist 2/week for the first 3 months followed by 1/week for the following 3 months	Control Control Group Control: There is no intervention associated with this arm of the study
Overall Study Withdrawal by Subject	9	2
Overall Study Death	1	0
Overall Study Protocol Violation	1	1
Overall Study Lost to Follow-up	0	1
Overall Study Physician Decision	1	0

Baseline Characteristics

Mobility Optimization Through Velocity Exercise

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Gait n=36 Participants The gait participants were randomized and attended 24 biweekly 45-minute sessions directed by a physical therapist, which were composed of guided strategies to optimize knee movements during treadmill walking, using computerized motion analysis with visual biofeedback.	Control n=22 Participants The control participants received their usual care for symptomatic knee osteoarthritis (OA) through their usual healthcare providers and were not asked to make changes to their lifestyle.Usual care for these subjects may have included a yearly visit with their physician, use of pain medications for knee symptoms, knee surgery, and/or physical therapy.	Total n=58 Participants Total of all reporting groups
Age, Continuous	69.1 years STANDARD_DEVIATION 7.3 • n=5 Participants	69.6 years STANDARD_DEVIATION 6.4 • n=7 Participants	69.3 years STANDARD_DEVIATION 7.35 • n=5 Participants
Sex: Female, Male Female	22 Participants n=5 Participants	10 Participants n=7 Participants	32 Participants n=5 Participants
Sex: Female, Male Male	14 Participants n=5 Participants	12 Participants n=7 Participants	26 Participants n=5 Participants
Region of Enrollment United States	36 participants n=5 Participants	22 participants n=7 Participants	58 participants n=5 Participants

PRIMARY outcome

Timeframe: 0,3,6, and 12 months

This is a questionnaire that evaluates self-reported difficulty in a person's ability to do discrete actions or activities primarily involving standing, stooping and fundamental walking activities without the help of others. Factors that may influence difficulty in task performance include pain, fatigue, fear, weakness, soreness, ailments, health conditions and disabilities. Scored from 14 to 70 with scores approaching 70 signifying high levels in ability to perform activities primarily involving standing, stooping, and fundamental walking (without assistance), and scores approaching 14 signifying low levels in ability to perform activities primarily involving standing, stooping, and fundamental walking (without assistance).

Outcome measures

Outcome measures
Measure	Gait n=29 Participants No adverse events	Control Group n=19 Participants No adverse events
Change in Basic Lower Limb Function (Late Life Function Index) Late Life Function and Disability Instrument Change from baseline to month 3	3.3 units on a scale Interval 1.1 to 5.5	-1.0 units on a scale Interval -3.7 to 1.7
Change in Basic Lower Limb Function (Late Life Function Index) Late Life Function and Disability Instrument Change from baseline to month 6	3.1 units on a scale Interval 0.5 to 5.7	0.8 units on a scale Interval -2.3 to 4.0
Change in Basic Lower Limb Function (Late Life Function Index) Late Life Function and Disability Instrument Change from baseline to month 12	3.9 units on a scale Interval -1.3 to 9.1	2.9 units on a scale Interval -3.7 to 9.5

SECONDARY outcome

Timeframe: 0,3,6 and 12 months

This is a 42-item self-administered questionnaire that covers five patient-relevant dimensions, including pain and knee-related symptoms. This instrument has been found to be a reliable and responsive measure in older adults with knee OA as well as sensitive to changes in pain and knee-related symptoms over 6- and 12-mo periods. Scored from 0 to 100 with 100 indicating no pain.

Outcome measures

Outcome measures
Measure	Gait n=29 Participants No adverse events	Control Group n=19 Participants No adverse events
Change in Knee Osteoarthritis Injury and Outcome Scale (KOOS) Pain Change from baseline to month 3	8.2 units on a scale Interval 2.8 to 13.5	1.1 units on a scale Interval -5.5 to 7.7
Change in Knee Osteoarthritis Injury and Outcome Scale (KOOS) Pain Change from baseline to month 6	5.4 units on a scale Interval 0.1 to 10.7	1.7 units on a scale Interval -4.8 to 8.2
Change in Knee Osteoarthritis Injury and Outcome Scale (KOOS) Pain Change from baseline to month 12	10.1 units on a scale Interval 4.4 to 15.8	2.8 units on a scale Interval -4.4 to 10.1

SECONDARY outcome

Timeframe: 0,3,6 and 12 months

This instrument has been found to be a reliable and responsive measure in older adults with knee OA as well as sensitive to changes in pain and knee-related symptoms over 6- and 12-mo periods. Scored from 0 to 100 with 100 indicating no symptoms.

Outcome measures

Outcome measures
Measure	Gait n=29 Participants No adverse events	Control Group n=19 Participants No adverse events
Change in KOOS Symptoms Change from baseline to month 3	11.5 units on a scale Interval 6.3 to 16.7	3.0 units on a scale Interval -3.4 to 9.4
Change in KOOS Symptoms Change from baseline to month 6	8.1 units on a scale Interval 2.3 to 13.8	1.8 units on a scale Interval -5.3 to 8.9
Change in KOOS Symptoms Change from baseline to month 12	8.5 units on a scale Interval 0.9 to 16.0	2.4 units on a scale Interval -7.1 to 12.0

SECONDARY outcome

Timeframe: 0,3,6 and 12 months

The LDCW included both 2-min walk distance and 400-m walk time. This measure has been shown to be predictive of changes in community mobility. Per the LDCW protocol, for participants unable to walk 400 m, gait speed was estimated from the 2-min walk distance, so that all participant data were on the same scale.

Outcome measures

Outcome measures
Measure	Gait n=29 Participants No adverse events	Control Group n=19 Participants No adverse events
Change in Long Distance Corridor Walk (LDCW) Time, Secs Change from baseline to month 3	11.5 seconds Interval 6.3 to 16.7	3.0 seconds Interval -3.4 to 9.4
Change in Long Distance Corridor Walk (LDCW) Time, Secs Change from baseline to month 6	8.1 seconds Interval 2.3 to 13.8	1.8 seconds Interval -5.3 to 8.9
Change in Long Distance Corridor Walk (LDCW) Time, Secs Change from baseline to month 12	8.5 seconds Interval 0.9 to 16.0	2.4 seconds Interval -7.1 to 12.0

SECONDARY outcome

Timeframe: 0,3,6, and 12 months

Functional limitations specific to ascending stairs were assessed with a times stair climb, using a standard eight-stair flight (stair height = 19 cm)

Outcome measures

Outcome measures
Measure	Gait n=29 Participants No adverse events	Control Group n=19 Participants No adverse events
Change in Stair Climb Time, Secs Change from baseline to month 3	0.2 seconds Interval -0.5 to 0.9	0.0 seconds Interval -0.9 to 0.8
Change in Stair Climb Time, Secs Change from baseline to month 6	-0.2 seconds Interval -1.3 to 1.0	-1.4 seconds Interval -2.9 to 0.0
Change in Stair Climb Time, Secs Change from baseline to month 12	-0.3 seconds Interval -1.3 to 0.7	-1.1 seconds Interval -2.4 to 0.1

SECONDARY outcome

Timeframe: 0,3,6,and 12 months

Measured as the total time (in seconds) required to stand five times from a seated position in a standardized chair without using arms.

Outcome measures

Outcome measures
Measure	Gait n=29 Participants No adverse events	Control Group n=19 Participants No adverse events
Change in Chair Stand Time Change from baseline to month 3	-0.9 seconds Interval -2.2 to 0.4	-1.0 seconds Interval -2.8 to 0.8
Change in Chair Stand Time Change from baseline to month 6	-1.9 seconds Interval -3.5 to -0.3	-3.0 seconds Interval -5.0 to -0.9
Change in Chair Stand Time Change from baseline to month 12	-2.5 seconds Interval -3.7 to -1.3	-2.9 seconds Interval -4.5 to -1.3

Adverse Events

Gait

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Control

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

Neil Segal

University of Iowa

Phone: 3193560737

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place