Hip OsteoarthritisLEAPNCT01938274
Leisure Expectations About Physical Activity Study
A study testing Educational intervention in people with Hip Osteoarthritis and Knee Osteoarthritis, run by West Virginia University at 1 site in United States.
Trial summary
To pilot test an activity-focused intervention that educates patients undergoing total hip (THA) or total knee (TKA) arthroplasty due to osteoarthritis about the appropriate type, frequency, intensity, and duration of expected leisure activities after surgery and to determine if the intervention changed expectations. Read more about this study
- Who is it for?
- Ages 45 years and older
- Conditions the study is for
- Hip Osteoarthritis, Knee Osteoarthritis
- What is being tested?
- Educational intervention
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jan 2018to 22 Jul 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
- The study includes male or female patients, aged 45 years and older who are scheduled for primary total hip or knee arthroplasty due to osteoarthritis.
Who cannot join
- Patients will be excluded from the study if the surgery is being performed for diagnosis other than osteoarthritis.
Trial locations and contacts
1 site in 1 country.
United States1 site
West Virginia University
Morgantown, West Virginia, 26506
About this study
Official title: Establishing Appropriate Activity Expectations After Total Joint Replacement
To pilot test an activity-focused intervention that educates patients undergoing total hip (THA) or total knee (TKA) arthroplasty due to osteoarthritis about the appropriate type, frequency, intensity, and duration of expected leisure activities after surgery and to determine if the intervention changed expectations.
Read the detailed description
Consecutive patients, aged 45 years and older, who are scheduled for primary total hip or knee arthroplasty due to osteoarthritis will be randomized to an intervention or control (no intervention) group. All patients will be interviewed by telephone prior to the intervention, by an interviewer blinded to group status, to collect data on current leisure activity and expected activity at 6 months after surgery. Patients will also complete a questionnaire to collect data on sociodemographic characteristics, comorbidities (American Academy of Orthopaedic Surgeons Comorbidity Index), pain intensity (0-10 scale), health-related quality of life (SF-12), hip-/knee-specific outcomes (Hip Dysfunction and Osteoarthritis Outcome Score/Knee Injury and Osteoarthritis Outcome Score), general expectations (Hospital for Special Surgery Total Hip/Knee Replacement Expectations Surveys), and stage of readiness for change.
All patients will receive usual medical care before surgery and visit the clinic to meet with the surgeon and nurse/physician assistant, and undergo pre-operative laboratory testing. Patients in the intervention group will also meet with a member of the research team to complete a 10-item pre-test, to assess knowledge of the key concepts in the intervention, and then be presented with a 20-minute slide presentation. The presentation will educate patients on the: 1) definition of physical activity and its associated health benefits for the general population and people with arthritis, (2) 2008 Physical Activity Guidelines for Americans, 3) appropriate types of aerobic activities that patients should engage in after THA/TKA (e.g., no- or low-impact activities), (4) appropriate intensity level for activities after THA/TKA (e.g., at least moderate intensity), (5) appropriate duration of participation in activities (e.g., in increments of 10 or more minutes), and (6) the appropriate amount of activity per week (e.g., ≥ 2.5 hours [150 minutes]).
Patients will then complete a satisfaction survey that will provide feedback on the content, format, and length of the intervention, and a post-test to measure mastery of the intervention material. The post-test will contain the same questions as the pre-test, but in a different order. The control group will not meet with the research team during their pre-operative visit. The control group will receive a written version of the intervention at the end of the study.
All patients will be re-interviewed by telephone one week after their visit to reassess leisure activity expectations. Data analyses will be conducted to determine: 1) the direction and magnitude of change expected in leisure activity between baseline and 6 months, 2) the change in the proportion of patients who expect to meet national physical activity guidelines 6 month after surgery, and 3) whether or not the intervention modified the type, frequency, duration, or intensity of expected leisure activity from pre- to post-administration.
- Conditions
- Hip Osteoarthritis, Knee Osteoarthritis
- Being tested
- Educational intervention
- Keywords
- Hip, Knee, Osteoarthritis, Arthroplasty, Physical Activity, Expectations, Leisure Activity
- Medical subject headings
- Osteoarthritis, Hip, Osteoarthritis, Knee, Osteoarthritis, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Educational interventionOther
A 30-minute discussion and slide presentation with a trained member of the research team.
| Study group | Role | What they receive |
|---|---|---|
| Educational intervention | Experimental | Patients in this group will receive a brief educational intervention to assist them in setting the appropriate expectations for leisure activity after surgery with respect to the type, amount, intensity, and duration of activity. Receives: Other: Educational intervention |
| Control group | No intervention | No intervention will be received. Patients will receive a written version of the education intervention at the end of the study. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in type, frequency, intensity, and duration of expected leisure activities from pre- to post-intervention.
The Historical Leisure Activity Questionnaire will be used to measure expected physical activity before and after the intervention
Measured: One-week prior to the educational intervention (Pre) (approximately 3-4 weeks before surgery) and one-week after the educational intervention (Post) (approximately 1-2 weeks before surgery).
Secondary outcomes (2)
Change in the proportion of patients who expect to meet nationally recommended physical activity levels 6 months after surgery.
The Historical Leisure Activity Questionnaire will be used to determine if patients expect to meet the nationally recommended physical activity levels 6 months after surgery (i.e., 2.5 hours or more of at least moderate-intensity aerobic activity per week in bouts of 10 or more minutes).
Measured: One-week prior to the educational intervention (Pre) (approximately 3-4 weeks before surgery) and one-week after the educational intervention (Post) (approximately 1-2 weeks before surgery).
Direction and magnitude of change expected in leisure activity between baseline (i.e., current activity) and 6 months
Expected activity at 6 months - baseline activity = expected change in activity
Measured: Baseline (approximately 3-4 weeks before surgery)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Sep 2013 (estimated)
- Study start1 Jan 2018 (estimated)
- Primary completionDec 2018 (estimated)
- Study completion22 Jul 2019
Why it stopped: Enrollment never started
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hip OsteoarthritisStudies 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- West Virginia University
- Sponsor type
- University, hospital or other
- Collaborators
- Agency for Healthcare Research and Quality (AHRQ)
- Responsible party
- Principal investigator, Dina L Jones, PT, PhD, West Virginia University
- Investigators
- Dina L. Jones, PT, PhD, Principal investigator, West Virginia University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01938274
- Sponsor's protocol ID
- R24HS018622
- Acronym
- LEAP
- Status last verified
- Jul 2019
- First submitted
- 12 Feb 2013
- Last updated
- 24 Jul 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Establishing Appropriate Activity Expectations After Total Joint Replacement
- ClinicalTrials.gov ID
- NCT01938274
- Acronym / sponsor ID
- LEAP / R24HS018622
- Conditions
- Hip Osteoarthritis, Knee Osteoarthritis
- Keywords
- Hip, Knee, Osteoarthritis, Arthroplasty, Physical Activity, Expectations, Leisure Activity
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Enrollment never started
- Enrolment
- 0 participants (actual)
- Lead sponsor
- West Virginia UniversityUniversity, hospital or other
- Collaborators
- Agency for Healthcare Research and Quality (AHRQ)
- Study start
- 1 Jan 2018 (estimated)
- Primary completion
- Dec 2018 (estimated)
- Study completion
- 22 Jul 2019 (actual)
- First posted
- 10 Sep 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To pilot test an activity-focused intervention that educates patients undergoing total hip (THA) or total knee (TKA) arthroplasty due to osteoarthritis about the appropriate type, frequency, intensity, and duration of expected leisure activities after surgery and to determine if the intervention changed expectations.
Detailed description
Consecutive patients, aged 45 years and older, who are scheduled for primary total hip or knee arthroplasty due to osteoarthritis will be randomized to an intervention or control (no intervention) group. All patients will be interviewed by telephone prior to the intervention, by an interviewer blinded to group status, to collect data on current leisure activity and expected activity at 6 months after surgery. Patients will also complete a questionnaire to collect data on sociodemographic characteristics, comorbidities (American Academy of Orthopaedic Surgeons Comorbidity Index), pain intensity (0-10 scale), health-related quality of life (SF-12), hip-/knee-specific outcomes (Hip Dysfunction and Osteoarthritis Outcome Score/Knee Injury and Osteoarthritis Outcome Score), general expectations (Hospital for Special Surgery Total Hip/Knee Replacement Expectations Surveys), and stage of readiness for change.
All patients will receive usual medical care before surgery and visit the clinic to meet with the surgeon and nurse/physician assistant, and undergo pre-operative laboratory testing. Patients in the intervention group will also meet with a member of the research team to complete a 10-item pre-test, to assess knowledge of the key concepts in the intervention, and then be presented with a 20-minute slide presentation. The presentation will educate patients on the: 1) definition of physical activity and its associated health benefits for the general population and people with arthritis, (2) 2008 Physical Activity Guidelines for Americans, 3) appropriate types of aerobic activities that patients should engage in after THA/TKA (e.g., no- or low-impact activities), (4) appropriate intensity level for activities after THA/TKA (e.g., at least moderate intensity), (5) appropriate duration of participation in activities (e.g., in increments of 10 or more minutes), and (6) the appropriate amount of activity per week (e.g., ≥ 2.5 hours [150 minutes]).
Patients will then complete a satisfaction survey that will provide feedback on the content, format, and length of the intervention, and a post-test to measure mastery of the intervention material. The post-test will contain the same questions as the pre-test, but in a different order. The control group will not meet with the research team during their pre-operative visit. The control group will receive a written version of the intervention at the end of the study.
All patients will be re-interviewed by telephone one week after their visit to reassess leisure activity expectations. Data analyses will be conducted to determine: 1) the direction and magnitude of change expected in leisure activity between baseline and 6 months, 2) the change in the proportion of patients who expect to meet national physical activity guidelines 6 month after surgery, and 3) whether or not the intervention modified the type, frequency, duration, or intensity of expected leisure activity from pre- to post-administration.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Educational intervention | Experimental | Other: Educational interventionPatients in this group will receive a brief educational intervention to assist them in setting the appropriate expectations for leisure activity after surgery with respect to the type, amount, intensity, and duration of activity. |
| Control group | No intervention | –No intervention will be received. Patients will receive a written version of the education intervention at the end of the study. |
Who may qualify
- Ages
- 45 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- The study includes male or female patients, aged 45 years and older who are scheduled for primary total hip or knee arthroplasty due to osteoarthritis.
Key exclusion criteria (1 listed)
- Patients will be excluded from the study if the surgery is being performed for diagnosis other than osteoarthritis.
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 |
|---|---|---|
| Educational interventionA 30-minute discussion and slide presentation with a trained member of the research team. | Other | Educational intervention |
Primary outcome
Change in type, frequency, intensity, and duration of expected leisure activities from pre- to post-intervention.
Time frame: One-week prior to the educational intervention (Pre) (approximately 3-4 weeks before surgery) and one-week after the educational intervention (Post) (approximately 1-2 weeks before surgery).
The Historical Leisure Activity Questionnaire will be used to measure expected physical activity before and after the intervention
2 secondary outcomes
Change in the proportion of patients who expect to meet nationally recommended physical activity levels 6 months after surgery.
Time frame: One-week prior to the educational intervention (Pre) (approximately 3-4 weeks before surgery) and one-week after the educational intervention (Post) (approximately 1-2 weeks before surgery).
Direction and magnitude of change expected in leisure activity between baseline (i.e., current activity) and 6 months
Time frame: Baseline (approximately 3-4 weeks before surgery)
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jul 2019.
- Individual participant dataSharing planned: No
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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.
Dina L. Jones, PT, PhD principal investigator
West Virginia University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Educational intervention in people with Hip Osteoarthritis and Knee Osteoarthritis, run by West Virginia University at 1 site in United States.
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 1 inclusion and 1 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: withdrawn, as of the sponsor's last update on 24 Jul 2019. 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 United States. 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?
The study was withdrawn before enrolling participants, so there are no results.
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?
Change in type, frequency, intensity, and duration of expected leisure activities from pre- to post-intervention. (time frame: One-week prior to the educational intervention (Pre) (approximately 3-4 weeks before surgery) and one-week after the educational intervention (Post) (approximately 1-2 weeks before surgery).). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 24 Jul 2019.