Trial Outcomes & Findings for Walking Skill Training Program Effects in Patients With Total Hip Arthroplasty (NCT NCT00808483)

NCT ID: NCT00808483

Last Updated: 2015-01-09

Results Overview

Participants walked in a 40 meter hospital corridor for 6 minutes.

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 68 participants
• Primary outcome timeframe: 5 months and 12 months
• Results posted on: 2015-01-09

Participant Flow

Participants were recruited at the hospital the day before surgery from October 2008 to March 2010.

Participant milestones

Measure	Walking Skill Training Group 12 sessions of participation in the walking skill training program. Walking skill training program: 12 individualized training sessions containing functional exercises like walking, stair climbing, balance training and with guidance from a physiotherapist.	Control Group No participation in the walking skill training group
From 3 to 5 Months After Surgery STARTED	35	33
From 3 to 5 Months After Surgery COMPLETED	33	32
From 3 to 5 Months After Surgery NOT COMPLETED	2	1
From 5 Months to 12 Months STARTED	33	32
From 5 Months to 12 Months COMPLETED	32	32
From 5 Months to 12 Months NOT COMPLETED	1	0

Reasons for withdrawal

Measure	Walking Skill Training Group 12 sessions of participation in the walking skill training program. Walking skill training program: 12 individualized training sessions containing functional exercises like walking, stair climbing, balance training and with guidance from a physiotherapist.	Control Group No participation in the walking skill training group
From 3 to 5 Months After Surgery Withdrawal by Subject	1	1
From 3 to 5 Months After Surgery Lack of Efficacy	1	0
From 5 Months to 12 Months Lack of Efficacy	1	0

Baseline Characteristics

Walking Skill Training Program Effects in Patients With Total Hip Arthroplasty

Baseline characteristics by cohort

Measure	Walking Skill Training Group n=35 Participants 12 sessions of participation in the walking skill training program. Walking skill training program: 12 individualized training sessions containing functional exercises like walking, stair climbing, balance training and sit-to-stand with guidance and supervision from a physiotherapist.	Control Group n=33 Participants No participation in the walking skill training group	Total n=68 Participants Total of all reporting groups
Age, Continuous	65 years n=5 Participants	66 years n=7 Participants	66 years n=5 Participants
Sex: Female, Male Female	21 Participants n=5 Participants	14 Participants n=7 Participants	35 Participants n=5 Participants
Sex: Female, Male Male	14 Participants n=5 Participants	19 Participants n=7 Participants	33 Participants n=5 Participants
BMI	27 kg/m^2 n=5 Participants	27 kg/m^2 n=7 Participants	27 kg/m^2 n=5 Participants

PRIMARY outcome

Timeframe: 5 months and 12 months

Participants walked in a 40 meter hospital corridor for 6 minutes.

Outcome measures

Measure	Walking Skill Training Group n=35 Participants 12 sessions of participation in the supervised walking skill training program. Walking skill training program: 12 individualized training sessions containing functional exercises like walking, stair climbing, balance training and with guidance from a physiotherapist.	Control Group n=33 Participants No participation in the walking skill training program
6 Minutes Walk Test (6MWT) 6MWT at 5 months	513 meters Interval 497.0 to 529.0	462 meters Interval 445.0 to 478.0
6 Minutes Walk Test (6MWT) 6MWT at 12 months	535 meters Interval 516.0 to 555.0	483 meters Interval 463.0 to 503.0

SECONDARY outcome

Timeframe: 5 months and 12 months

Self-reported symptoms, pain, physical function, function in sport and recreation, quality of life. 0 (worse) - 100 (best)

Outcome measures

Measure	Walking Skill Training Group n=35 Participants 12 sessions of participation in the supervised walking skill training program. Walking skill training program: 12 individualized training sessions containing functional exercises like walking, stair climbing, balance training and with guidance from a physiotherapist.	Control Group n=33 Participants No participation in the walking skill training program
Hip Dysfunction and Osteoarthritis Outcome Score (HOOS) HOOS pain at 5 months	92 units on a scale Interval 89.0 to 95.0	90 units on a scale Interval 87.0 to 93.0
Hip Dysfunction and Osteoarthritis Outcome Score (HOOS) HOOS pain at 12 months	94 units on a scale Interval 91.0 to 96.0	94 units on a scale Interval 92.0 to 97.0

SECONDARY outcome

Timeframe: 5 months and 12 months

Pain and physical function. 0 (worse) - 100 (best)

Outcome measures

Measure	Walking Skill Training Group n=35 Participants 12 sessions of participation in the supervised walking skill training program. Walking skill training program: 12 individualized training sessions containing functional exercises like walking, stair climbing, balance training and with guidance from a physiotherapist.	Control Group n=33 Participants No participation in the walking skill training program
Harris Hip Score (HHS) HHS at 5 months	93 units on a scale Interval 91.0 to 96.0	90 units on a scale Interval 87.0 to 92.0
Harris Hip Score (HHS) HHS at 12 months	96 units on a scale Interval 93.0 to 98.0	92 units on a scale Interval 90.0 to 95.0

SECONDARY outcome

Timeframe: 5 months and 12 months

Self-reported self-efficacy in activities. 0 (worse) - 100 (best).

Outcome measures

Measure	Walking Skill Training Group n=35 Participants 12 sessions of participation in the supervised walking skill training program. Walking skill training program: 12 individualized training sessions containing functional exercises like walking, stair climbing, balance training and with guidance from a physiotherapist.	Control Group n=33 Participants No participation in the walking skill training program
Self-efficacy Self-efficacy at 5 months	86 units on a scale Interval 82.0 to 90.0	81 units on a scale Interval 77.0 to 84.0
Self-efficacy Self-efficacy at 12 months	88 units on a scale Interval 83.0 to 92.0	84 units on a scale Interval 79.0 to 88.0

SECONDARY outcome

Timeframe: 5 months and 12 months

Ascend and descend 8 steps with a step hight of 16 cm as fast as they could without running. Few seconds (best) - many seconds (worse)

Outcome measures

Measure	Walking Skill Training Group n=35 Participants 12 sessions of participation in the supervised walking skill training program. Walking skill training program: 12 individualized training sessions containing functional exercises like walking, stair climbing, balance training and with guidance from a physiotherapist.	Control Group n=33 Participants No participation in the walking skill training program
Stair Climbing Test (ST) ST at 5 months	11 seconds Interval 10.0 to 11.0	12 seconds Interval 11.0 to 13.0
Stair Climbing Test (ST) ST at 12 months	10 seconds Interval 9.0 to 11.0	12 seconds Interval 11.0 to 13.0

SECONDARY outcome

Timeframe: 5 months and 12 months

Active range of motion (ROM) in hip extension test. Degrees is registered. 0 degrees indicates zero position of the hip, minus digrees indicates flexion contracture.

Outcome measures

Measure	Walking Skill Training Group n=35 Participants 12 sessions of participation in the supervised walking skill training program. Walking skill training program: 12 individualized training sessions containing functional exercises like walking, stair climbing, balance training and with guidance from a physiotherapist.	Control Group n=33 Participants No participation in the walking skill training program
ROM Extension ROM extension at 5 months	0 degrees Interval -1.0 to 2.0	-2 degrees Interval -3.0 to -1.0
ROM Extension ROM extension at 12 months	0 degrees Interval -2.0 to 1.0	-1 degrees Interval -3.0 to 0.0

SECONDARY outcome

Timeframe: 5 months and 12 months

Tests of general mobility, muscle strength, balance/coordination, and endurance. 40 (worse) - 0 (best)

Outcome measures

Measure	Walking Skill Training Group n=35 Participants 12 sessions of participation in the supervised walking skill training program. Walking skill training program: 12 individualized training sessions containing functional exercises like walking, stair climbing, balance training and with guidance from a physiotherapist.	Control Group n=33 Participants No participation in the walking skill training program
Index of Muscle Function (IMF) IMF at 5 months	8 units on a scale Interval 7.0 to 9.0	11 units on a scale Interval 9.0 to 12.0
Index of Muscle Function (IMF) IMF at 12 months	7 units on a scale Interval 6.0 to 9.0	10 units on a scale Interval 8.0 to 11.0

SECONDARY outcome

Timeframe: 5 months and 12 months

Test of dynamic balance. Number of steps on and outside the line is registered. 0 (best)

Outcome measures

Measure	Walking Skill Training Group n=35 Participants 12 sessions of participation in the supervised walking skill training program. Walking skill training program: 12 individualized training sessions containing functional exercises like walking, stair climbing, balance training and with guidance from a physiotherapist.	Control Group n=33 Participants No participation in the walking skill training program
Figure-of-eight Test Figure-of-eight at 5 months	7 steps Interval 5.0 to 9.0	10 steps Interval 8.0 to 12.0
Figure-of-eight Test Figure-of-eight at 12 months	7 steps Interval 5.0 to 8.0	8 steps Interval 7.0 to 10.0

Adverse Events

Walking Skill Training Group

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Control Group

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

Professor Anne Marit Mengshoel

University of Oslo

Phone: 004790036933

Email: a.m.mengshoel@medisin.uio.no

Results disclosure agreements

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