Trial record 7 of 35 for:    LEAP

Leisure Expectations About Physical Activity Study (LEAP)

This study is currently recruiting participants. (see Contacts and Locations)
Verified September 2013 by West Virginia University
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Dina L. Jones, PT, PhD, West Virginia University
ClinicalTrials.gov Identifier:
NCT01938274
First received: February 12, 2013
Last updated: September 4, 2013
Last verified: September 2013
  Purpose

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 Intervention
Hip Osteoarthritis
Knee Osteoarthritis
Other: Educational intervention

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Supportive Care
Official Title: Establishing Appropriate Activity Expectations After Total Joint Replacement

Resource links provided by NLM:


Further study details as provided by West Virginia University:

Primary Outcome Measures:
  • 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). ] [ Designated as safety issue: No ]
    The Historical Leisure Activity Questionnaire will be used to measure expected physical activity before and after the intervention


Secondary Outcome Measures:
  • 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). ] [ Designated as safety issue: No ]
    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).

  • 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) ] [ Designated as safety issue: No ]
    Expected activity at 6 months - baseline activity = expected change in activity


Estimated Enrollment: 60
Study Start Date: September 2013
Estimated Study Completion Date: August 2014
Estimated Primary Completion Date: August 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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
Not applicable
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.

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.

  Eligibility

Ages Eligible for Study:   45 Years and older
Genders Eligible for Study:   Both
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01938274

Contacts
Contact: Jennifer L. Eicher, BS 304-293-0742 jeicher@hsc.wvu.edu

Locations
United States, West Virginia
West Virginia University Recruiting
Morgantown, West Virginia, United States, 26506
Contact: Jennifer L. Eicher, BS    304-293-0742    Jeicher@hsc.wvu.edu   
Contact: Dina L. Jones, PT, PhD    304-293-1078    Dljones@hsc.wvu.edu   
Sponsors and Collaborators
West Virginia University
Investigators
Principal Investigator: Dina L. Jones, PT, PhD West Virginia University
  More Information

No publications provided

Responsible Party: Dina L. Jones, PT, PhD, Associate Professor, West Virginia University
ClinicalTrials.gov Identifier: NCT01938274     History of Changes
Other Study ID Numbers: R24 HS018622
Study First Received: February 12, 2013
Last Updated: September 4, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by West Virginia University:
Hip
Knee
Osteoarthritis
Arthroplasty
Physical Activity
Expectations
Leisure Activity

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

ClinicalTrials.gov processed this record on July 29, 2014