Arthroplasty, Replacement, HipNCT00808483

Walking Skill Training Program Effects in Patients With Total Hip Arthroplasty

A study testing Walking skill training program in people with Arthroplasty, Replacement, Hip and Exercise Therapy, run by University of Oslo at 1 site in Norway.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Rehabilitation plays an important part after total hip arthroplasty. In this common practice few studies have been performed on this issue. The aims of this study were: 1. to examine the immediate effects of a walking skill training program on walking, stair climbing, balance, self-reported physical functioning… Read more about this study

Who is it for?: Ages 45 years and older
Conditions the study is for: Arthroplasty, Replacement, Hip, Exercise Therapy
What is being tested?: Walking skill training program
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 68 participants
Where: 1 siteNorway
Study dates: Oct 2008to Apr 2011
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 45 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Primary cox arthrosis
Good written and oral Norwegian language

Who cannot join

Severe hip arthrosis in the other hip or severe gon arthrosis that restricted walking
Neurological disorders
Rheumatoid arthritis

Trial locations and contacts

1 site in 1 country.

Norway1 site

Department of health science, University of Oslo
Oslo, Oslo 0317, 1089 Blindern

Other trials in Norway

About this study

Official title: Effect of a Walking Skill Training Program in Patients Who Have Undergone Total Hip Arthroplasty: Followup One Year After Surgery

Rehabilitation plays an important part after total hip arthroplasty. In this common practice few studies have been performed on this issue.

The aims of this study were:

to examine the immediate effects of a walking skill training program on walking, stair climbing, balance, self-reported physical functioning physical functioning, pain and self-efficacy compared to a control group without supervised physiotherapy
to examine whether the effects persisted 12 months after surgery

Conditions: Arthroplasty, Replacement, Hip, Exercise Therapy
Being tested: Walking skill training program
Keywords: total hip arthroplasty, physical functioning, training program, self-efficacy, exercise therapy, walking

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Walking skill training programOther
12 individualized training sessions containing functional exercises like walking, stair climbing, balance training and with supervision and guidance from a physiotherapist.

Study groups in NCT00808483
Study group	Role	What they receive
Walking skill training group	Experimental	Participation in the supervised walking skill training program. Receives: Other: Walking skill training program
Control group	No intervention	No participation in the supervised walking skill training program

What is being measured

The primary outcome is the main question the study is designed to answer.

6 Minutes Walk Test (6MWT)
Participants walked in a 40 meter hospital corridor for 6 minutes.
Measured: 5 months and 12 months

Secondary outcomes (7)

Hip Dysfunction and Osteoarthritis Outcome Score (HOOS)
Self-reported symptoms, pain, physical function, function in sport and recreation, quality of life. 0 (worse) - 100 (best)
Measured: 5 months and 12 months
Harris Hip Score (HHS)
Pain and physical function. 0 (worse) - 100 (best)
Measured: 5 months and 12 months
Self-efficacy
Self-reported self-efficacy in activities. 0 (worse) - 100 (best).
Measured: 5 months and 12 months
Stair Climbing Test (ST)
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)
Measured: 5 months and 12 months
ROM Extension
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.
Measured: 5 months and 12 months
Index of Muscle Function (IMF)
Tests of general mobility, muscle strength, balance/coordination, and endurance. 40 (worse) - 0 (best)
Measured: 5 months and 12 months
Figure-of-eight Test
Test of dynamic balance. Number of steps on and outside the line is registered. 0 (best)
Measured: 5 months and 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Oct 2008Apr 2011

First posted15 Dec 2008 (estimated)
Study startOct 2008
Primary completionApr 2011
Study completionApr 2011

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Arthroplasty, Replacement, HipStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind
Who is masked: Outcomes assessor
Enrolment: 68 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00808483
Sponsor's protocol ID: 2008/2325
Status last verified: Jan 2015
First submitted: 12 Dec 2008
Last updated: 9 Jan 2015
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

RecruitingObservational study
The restor3d Outcomes Registry
Joint Replacement, Arthropathy
RecruitingObservational study
Z1 Hip System: Post-Market Clinical Follow Up Study
Hip Osteoarthritis, Acute Traumatic Fracture of the Femoral Head or Neck
RecruitingPhase 4
Low-Volume Pericapsular Nerve Group (PENG) Block With Dexamethasone vs Standard-Volume PENG Block After Total Hip Arthroplasty
Pain, Postoperative, Muscle Weakness
Not yet recruitingObservational study
Preoperative Muscle Stiffness, Functional Reserve, and Postoperative Quality of Recovery in Lower Extremity Arthroplasty
Osteoarthritis (Knee / Hip), Sarcopenia
Not yet recruitingObservational study
Carotid Ultrasound for Post-Spinal Anesthesia Hypotension in Elderly Hip Surgery
Hypotension After Spinal Anesthesia

All Arthroplasty, Replacement, Hip trials

Study at a glance

From the registry record, last updated by the sponsor on 9 Jan 2015. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Effect of a Walking Skill Training Program in Patients Who Have Undergone Total Hip Arthroplasty: Followup One Year After Surgery
ClinicalTrials.gov ID: NCT00808483
Acronym / sponsor ID: 2008/2325
Conditions: Arthroplasty, Replacement, Hip, Exercise Therapy
Keywords: total hip arthroplasty, physical functioning, training program, self-efficacy, exercise therapy, walking
Study type: Interventional
Recruitment status: Completed
Enrolment: 68 participants (actual)
Lead sponsor: University of OsloUniversity, hospital or other
Study start: Oct 2008
Primary completion: Apr 2011 (actual)
Study completion: Apr 2011 (actual)
First posted: 15 Dec 2008 (estimated)
Results: Posted 9 Jan 2015

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Rehabilitation plays an important part after total hip arthroplasty. In this common practice few studies have been performed on this issue.

The aims of this study were:

to examine the immediate effects of a walking skill training program on walking, stair climbing, balance, self-reported physical functioning physical functioning, pain and self-efficacy compared to a control group without supervised physiotherapy
to examine whether the effects persisted 12 months after surgery

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind (outcomes assessor)
Number of arms: 2

Arm	Type	Receives
Walking skill training group	Experimental	Other: Walking skill training programParticipation in the supervised walking skill training program.
Control group	No intervention	–No participation in the supervised walking skill training program

Who may qualify

Ages: 45 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (2 listed)

Primary cox arthrosis
Good written and oral Norwegian language

Key exclusion criteria (3 listed)

Severe hip arthrosis in the other hip or severe gon arthrosis that restricted walking
Neurological disorders
Rheumatoid arthritis

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Walking skill training program12 individualized training sessions containing functional exercises like walking, stair climbing, balance training and with supervision and guidance from a physiotherapist.	Other	Walking skill training group

Primary outcome

6 Minutes Walk Test (6MWT)
Time frame: 5 months and 12 months
Participants walked in a 40 meter hospital corridor for 6 minutes.

7 secondary outcomes

Hip Dysfunction and Osteoarthritis Outcome Score (HOOS)
Time frame: 5 months and 12 months
Harris Hip Score (HHS)
Time frame: 5 months and 12 months
Self-efficacy
Time frame: 5 months and 12 months
Stair Climbing Test (ST)
Time frame: 5 months and 12 months
ROM Extension
Time frame: 5 months and 12 months
Index of Muscle Function (IMF)
Time frame: 5 months and 12 months
Figure-of-eight Test
Time frame: 5 months and 12 months

Results and safety

Results posted to the registry on 9 Jan 2015, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Walking Skill Training Group	35	33
Control Group	33	32

Primary outcome: 6 Minutes Walk Test (6MWT)

Time frame: 5 months and 12 months. Mean (95% Confidence Interval). Unit: meters

Measure	Walking Skill Training Group n = 35	Control Group n = 33
6MWT at 5 months	513 (497 to 529)	462 (445 to 478)
6MWT at 12 months	535 (516 to 555)	483 (463 to 503)

7 secondary outcomes are reported in the full results.

Adverse events

Time frame: at 5 months (after the training program was completed) and at followup at 12 months. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Walking Skill Training Group	0 of 35 (0%)	0 of 35 (0%)	Not reported
Control Group	0 of 33 (0%)	0 of 33 (0%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 9 Jan 2015.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Related trials for Arthroplasty, Replacement, Hip

RecruitingObservational study
The restor3d Outcomes Registry
Joint Replacement, Arthropathy
RecruitingObservational study
Z1 Hip System: Post-Market Clinical Follow Up Study
Hip Osteoarthritis, Acute Traumatic Fracture of the Femoral Head or Neck
RecruitingPhase 4
Low-Volume Pericapsular Nerve Group (PENG) Block With Dexamethasone vs Standard-Volume PENG Block After Total Hip Arthroplasty
Pain, Postoperative, Muscle Weakness
Not yet recruitingObservational study
Preoperative Muscle Stiffness, Functional Reserve, and Postoperative Quality of Recovery in Lower Extremity Arthroplasty
Osteoarthritis (Knee / Hip), Sarcopenia
Not yet recruitingObservational study
Carotid Ultrasound for Post-Spinal Anesthesia Hypotension in Elderly Hip Surgery
Hypotension After Spinal Anesthesia

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Kristi E Heiberg, PhD principal investigator

University of Oslo

Kristi E Heiberg, PhD principal investigator

Bærum Hospital Vestre Viken

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Walking skill training program in people with Arthroplasty, Replacement, Hip and Exercise Therapy, run by University of Oslo at 1 site in Norway.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 9 Jan 2015. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Norway. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 9 Jan 2015). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

6 Minutes Walk Test (6MWT) (time frame: 5 months and 12 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00808483.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jan 2015.