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Leisure Expectations About Physical Activity Study (LEAP)

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ClinicalTrials.gov Identifier: NCT01938274
Recruitment Status : Withdrawn (Enrollment never started)
First Posted : September 10, 2013
Last Update Posted : July 24, 2019
Sponsor:
Collaborator:
Agency for Healthcare Research and Quality (AHRQ)
Information provided by (Responsible Party):
Dina L Jones, PT, PhD, West Virginia University

Brief 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.

Condition or disease Intervention/treatment Phase
Hip Osteoarthritis Knee Osteoarthritis Other: Educational intervention Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Supportive Care
Official Title: Establishing Appropriate Activity Expectations After Total Joint Replacement
Estimated Study Start Date : January 1, 2018
Estimated Primary Completion Date : December 2018
Actual Study Completion Date : July 22, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Osteoarthritis

Arm Intervention/treatment
Experimental: Educational intervention
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.
Other: Educational intervention
A 30-minute discussion and slide presentation with a trained member of the research team.

No Intervention: Control group
No intervention will be received. Patients will receive a written version of the education intervention at the end of the study.



Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. 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). ]
    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).

  2. 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) ]
    Expected activity at 6 months - baseline activity = expected change in activity



Information from the National Library of Medicine

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Ages Eligible for Study:   45 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • Patients will be excluded from the study if the surgery is being performed for diagnosis other than osteoarthritis.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01938274


Locations
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United States, West Virginia
West Virginia University
Morgantown, West Virginia, United States, 26506
Sponsors and Collaborators
West Virginia University
Agency for Healthcare Research and Quality (AHRQ)
Investigators
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Principal Investigator: Dina L. Jones, PT, PhD West Virginia University

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Responsible Party: Dina L Jones, PT, PhD, Professor, West Virginia University
ClinicalTrials.gov Identifier: NCT01938274     History of Changes
Other Study ID Numbers: R24HS018622 ( U.S. AHRQ Grant/Contract )
First Posted: September 10, 2013    Key Record Dates
Last Update Posted: July 24, 2019
Last Verified: July 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Dina L Jones, PT, PhD, West Virginia University:
Hip
Knee
Osteoarthritis
Arthroplasty
Physical Activity
Expectations
Leisure Activity

Additional relevant MeSH terms:
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Osteoarthritis
Osteoarthritis, Knee
Osteoarthritis, Hip
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases