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

October 31, 2023 updated by: Oslo Metropolitan University

Better Before - Better After: Prehabilitation Program for Older Patients Awaiting Total Hip Replacement. A Randomised Controlled Trial

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Active, not recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
103

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • Norway
      • Oslo, Norway, 0130
        • OsloMet

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

70 years and older (Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Active Comparator: Intervention group
Exercise interventions for 6-12 weeks. Adherence is monitored with day journals
Behavioral: Exercise
Exercises in group and/or individually
No Intervention: Control group
Care as usual

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Change in gait speed
Time Frame: Change measure: Baseline, within one week after intervention, 6 weeks after intervention, 3 months after intervention, 6 months after intervention and 12 months after intervention
40 meters Fast-Paced Walk test
Change measure: Baseline, within one week after intervention, 6 weeks after intervention, 3 months after intervention, 6 months after intervention and 12 months after intervention

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Change in aerobic capacity
Time Frame: 1 week before intervention, directly after intervention as well as 6 and 12 weeks after TJA-surgery
6 min walk test
1 week before intervention, directly after intervention as well as 6 and 12 weeks after TJA-surgery
Change in pain measured with numeric rating scale (NRS)
Time Frame: Change measure: Baseline, within one week after intervention, 6 weeks after intervention and 3 months after intervention
NRS - Single score, low score indicates low pain, high score indicated high levels of pain
Change measure: Baseline, within one week after intervention, 6 weeks after intervention and 3 months after intervention
Length of stay in hospital
Time Frame: From date of hospital admission until the date of hospital discharge, assessed up to 12 months
Number of days
From date of hospital admission until the date of hospital discharge, assessed up to 12 months
Change in physical function
Time Frame: Change measure: Baseline, within one week after intervention, 6 weeks after intervention, 3 months after intervention, 6 months after intervention and 12 months after intervention
30 second sit-to stand test
Change measure: Baseline, within one week after intervention, 6 weeks after intervention, 3 months after intervention, 6 months after intervention and 12 months after intervention
Change in transitional ambulation
Time Frame: Change measure: Baseline, within one week after intervention, 6 weeks after intervention, 3 months after intervention, 6 months after intervention and 12 months after intervention
Timed-up and go Test (TUG)
Change measure: Baseline, within one week after intervention, 6 weeks after intervention, 3 months after intervention, 6 months after intervention and 12 months after intervention
Change in the ability to climb stairs
Time Frame: Change measure: Baseline, within one week after intervention, 6 weeks after intervention, 3 months after intervention, 6 months after intervention and 12 months after intervention
Stair-climb test. Timed performance from start to stop
Change measure: Baseline, within one week after intervention, 6 weeks after intervention, 3 months after intervention, 6 months after intervention and 12 months after intervention
Change in Health Status measured with EuroQol-5 dimensions (EQ-5D)
Time Frame: Change measure: Baseline, within one week after intervention, 6 weeks after intervention, 3 months after intervention, 6 months after intervention and 12 months after intervention
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)
Change measure: Baseline, within one week after intervention, 6 weeks after intervention, 3 months after intervention, 6 months after intervention and 12 months after intervention

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Oslo Metropolitan University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Odd-Einar Svinøy, MSc, OsloMet

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 1, 2019

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
May 30, 2024

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 31, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 6, 2018

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 25, 2018

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 26, 2018

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
November 2, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 31, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
November 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 2018/503

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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