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Better Before - Better After: Prehabilitation Program for Older Patients Awaiting Total Hip Replacement

Primary Purpose

Arthritis of Hip

Status
Recruiting
Phase
Not Applicable
Locations
Norway
Study Type
Interventional
Intervention
Exercise
Sponsored by
Oslo Metropolitan University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Arthritis of Hip focused on measuring exercise, prehabilitation, arthritis, quality of life, osteoarthritis, rehabilitation

Eligibility Criteria

70 Years - undefined (Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Participants 70 years or older living at home with residential address in the county of Oslo or Akershus scheduled for elective primary total hip replacement due to end-stage osteoarthritis.
  • Harris Hip Score >60.
  • Participants must also be capable in Norwegian and be able to follow exercise sessions.

Exclusion Criteria:

  • Patients with known rheumatoid arthritis or medical contraindications or those who are scheduled for revision of hip arthroplasty
  • Unable to speak and understand the Norwegian language.
  • Patients with neurological disorders affecting gait
  • Medical contraindications for exercise

Sites / Locations

  • OsloMetRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

No Intervention

Arm Label

Intervention group

Control group

Arm Description

Exercise interventions for 6-12 weeks. Adherence is monitored with day journals

Care as usual

Outcomes

Primary Outcome Measures

Change in gait speed
40 meters Fast-Paced Walk test

Secondary Outcome Measures

Change in physical function
30 second sit-to stand test
Change in aerobic capacity
6 min walk test
Change in transitional ambulation
Timed-up and go Test (TUG)
Change in pain measured with numeric rating scale (NRS)
NRS - Single score, low score indicates low pain, high score indicated high levels of pain
Length of stay in hospital
Number of days
Change in the ability to climb stairs
Stair-climb test. Timed performance from start to stop
Change in Health Status measured with EuroQol-5 dimensions (EQ-5D)
EQ-5D, five dimensions of health scored from 1-5, with 1 being no problem and 2-5 indicate increasing problem (higher score = increase in problem)

Full Information

First Posted
June 6, 2018
Last Updated
September 9, 2020
Sponsor
Oslo Metropolitan University
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1. Study Identification

Unique Protocol Identification Number
NCT03602105
Brief Title
Better Before - Better After: Prehabilitation Program for Older Patients Awaiting Total Hip Replacement
Official Title
Better Before - Better After: Prehabilitation Program for Older Patients Awaiting Total Hip Replacement. A Randomised Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
September 2020
Overall Recruitment Status
Recruiting
Study Start Date
March 1, 2019 (Actual)
Primary Completion Date
April 30, 2022 (Anticipated)
Study Completion Date
March 31, 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Oslo Metropolitan University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
Health professions need to prepare for the large increase in the number of older people with OA requiring health services including TJA surgery. Older age and poor physical function influences the postoperative prognosis of TJA. At discharge from hospital after TJA, studies have shown that gait speed can be severely impaired among older patients. The investigators hypothesize that an exercise program of 6-12 weeks will be beneficial for patients that are undergoing TJA.
Detailed Description
More than 300.000 Norwegians above 20 years of age have osteoarthritis (OA) . There has been a significant increase in the prevalence of OA over the decades. In the United States knee OA affects 19% of adults aged 45 years or older. OA is associated with an extensive high economic and personal burden, largely attributable to the effects of disability, comorbid disease, and the expense of treatment. Given the aging population, the number of total joint arthroplasty procedures (TJA) for hip and knee is likely to increase substantially. In light of poor physical function prior to surgery among older patients and the likelihood of an added decrease during hospitalization and risk of poorer outcome after surgery, it is hypothesised that prehabilitation (preoperative exercise) would improve outcomes after surgery, however evidence for its efficacy is still lacking

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Arthritis of Hip
Keywords
exercise, prehabilitation, arthritis, quality of life, osteoarthritis, rehabilitation

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
128 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Intervention group
Arm Type
Active Comparator
Arm Description
Exercise interventions for 6-12 weeks. Adherence is monitored with day journals
Arm Title
Control group
Arm Type
No Intervention
Arm Description
Care as usual
Intervention Type
Behavioral
Intervention Name(s)
Exercise
Intervention Description
Exercises in group and/or individually
Primary Outcome Measure Information:
Title
Change in gait speed
Description
40 meters Fast-Paced Walk test
Time Frame
Change measure: Baseline, within one week after intervention, 6 weeks after intervention and 3 months after intervention
Secondary Outcome Measure Information:
Title
Change in physical function
Description
30 second sit-to stand test
Time Frame
Change measure: Baseline, within one week after intervention, 6 weeks after intervention and 3 months after intervention
Title
Change in aerobic capacity
Description
6 min walk test
Time Frame
1 week before intervention, directly after intervention as well as 6 and 12 weeks after TJA-surgery
Title
Change in transitional ambulation
Description
Timed-up and go Test (TUG)
Time Frame
Change measure: Baseline, within one week after intervention, 6 weeks after intervention and 3 months after intervention
Title
Change in pain measured with numeric rating scale (NRS)
Description
NRS - Single score, low score indicates low pain, high score indicated high levels of pain
Time Frame
Change measure: Baseline, within one week after intervention, 6 weeks after intervention and 3 months after intervention
Title
Length of stay in hospital
Description
Number of days
Time Frame
From date of hospital admission until the date of hospital discharge, assessed up to 12 months
Title
Change in the ability to climb stairs
Description
Stair-climb test. Timed performance from start to stop
Time Frame
Change measure: Baseline, within one week after intervention, 6 weeks after intervention and 3 months after intervention
Title
Change in Health Status measured with EuroQol-5 dimensions (EQ-5D)
Description
EQ-5D, five dimensions of health scored from 1-5, with 1 being no problem and 2-5 indicate increasing problem (higher score = increase in problem)
Time Frame
Change measure: Baseline, within one week after intervention, 6 weeks after intervention and 3 months after intervention

10. Eligibility

Sex
All
Minimum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Participants 70 years or older living at home with residential address in the county of Oslo or Akershus scheduled for elective primary total hip replacement due to end-stage osteoarthritis. Harris Hip Score >60. Participants must also be capable in Norwegian and be able to follow exercise sessions. Exclusion Criteria: Patients with known rheumatoid arthritis or medical contraindications or those who are scheduled for revision of hip arthroplasty Unable to speak and understand the Norwegian language. Patients with neurological disorders affecting gait Medical contraindications for exercise
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Odd-Einar Svinøy, MSc
Phone
+47 67 23 88 21
Email
odd-einar.svinoy@oslomet.no
First Name & Middle Initial & Last Name or Official Title & Degree
Gunvor Hilde, PhD
Phone
+47 67 23 68 97
Email
gunvor.hilde@oslomet.no
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Odd-Einar Svinøy, MSc
Organizational Affiliation
OsloMet
Official's Role
Principal Investigator
Facility Information:
Facility Name
OsloMet
City
Oslo
ZIP/Postal Code
0130
Country
Norway
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Odd-Einar Svinøy, MSC
Phone
+4798443171
Email
oddeina@oslomet.no

12. IPD Sharing Statement

Plan to Share IPD
Undecided
Citations:
Citation
Slatkowsky-Christensen B, Grotle M. Artrose i Norge. Norsk Epidemiologi 2008;18(1)
Results Reference
background
PubMed Identifier
28808025
Citation
Wallace IJ, Worthington S, Felson DT, Jurmain RD, Wren KT, Maijanen H, Woods RJ, Lieberman DE. Knee osteoarthritis has doubled in prevalence since the mid-20th century. Proc Natl Acad Sci U S A. 2017 Aug 29;114(35):9332-9336. doi: 10.1073/pnas.1703856114. Epub 2017 Aug 14.
Results Reference
background
PubMed Identifier
19817509
Citation
Bitton R. The economic burden of osteoarthritis. Am J Manag Care. 2009 Sep;15(8 Suppl):S230-5.
Results Reference
background
PubMed Identifier
31892650
Citation
Svinoy OE, Bergland A, Risberg MA, Pripp AH, Hilde G. Better before-better after: efficacy of prehabilitation for older patients with osteoarthritis awaiting total hip replacement-a study protocol for a randomised controlled trial in South-Eastern Norway. BMJ Open. 2019 Dec 30;9(12):e031626. doi: 10.1136/bmjopen-2019-031626.
Results Reference
derived

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Better Before - Better After: Prehabilitation Program for Older Patients Awaiting Total Hip Replacement

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