Clinical trial NCT04641546: Effectiveness of Occupation-Based Intervention Compared With Therapeutic Exercise for Older Adults With Shoulder OA.
Official title: Effectiveness of an Occupation-Based Intervention Compared With Therapeutic Exercise for Older Adults With Shoulder Osteoarthritis: A Pilot Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Osteoarthritis Shoulder
Lead sponsor: Bay Path University
Sponsor class: OTHER
First posted: 2020-11-24
Enrollment: 10
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized Controlled Trial
Primary purpose: TREATMENT

Brief summary: As a registered and licensed occupational therapist, I completed a six-week evidence based research study to determine the effects of occupation-based intervention and therapeutic exercises versus therapeutic exercises alone.

Detailed description: Importance: There is a need for evidence to support occupation-based intervention (OBI) for older adults with shoulder osteoarthritis (OA).

Objective: To evaluate the effectiveness of OBI on function in older adults with shoulder OA compared to therapeutic exercise (TE).

Design: Randomized controlled trial. Six-week intervention. 1-week and 4-week follow-up.

Setting: Outpatient clinic. Participants: Ten older adults with diagnosis of shoulder OA via convenience sampling.

Intervention: Participants were seen two times/week for six weeks. The OBI group completed 30 minutes of TE followed by 30 minutes of OBI. The TE group completed 60 minutes of TE.

Outcome and Measures: Functional outcomes were assessed at pre-, 1-week post, and 4-weeks posttreatment using the QuickDASH as the primary outcome measure.

Eligibility criteria: Inclusion Criteria:

* Diagnosis of shoulder osteoarthritis (confirmed by physician examination or radiographic imaging)
* Aged 65 years or older

Exclusion Criteria:

* Previous shoulder injuries
* Acute pathology
* Previous shoulder surgery
* Current use of pain medication
* Inflammatory arthritis
* Upper extremity neuropathy or myopathy
* Current participation in a home exercise program
* Score of \<18 on the Mini-Mental State Examination (MMSE)

Primary outcomes:
measure: Quick Disabilities of the Arm, Shoulder and Hand (QuickDASH) Baseline scores
timeFrame: Pre-Intervention
measure: Change between Pre-Intervention and 1-week Post-Intervention Quick Disabilities of the Arm, Shoulder and Hand (QuickDASH) scores
timeFrame: 1-week Post-Intervention
measure: Change between Pre-Intervention and 4-weeks Post-Intervention Quick Disabilities of the Arm, Shoulder and Hand (QuickDASH) scores
timeFrame: 4-weeks Post-Intervention
measure: Change between 1-week and 4-weeks Post-Intervention Quick Disabilities of the Arm, Shoulder and Hand (QuickDASH) scores
timeFrame: 4-weeks Post-Intervention
Secondary outcomes:
measure: Canadian Occupational Performance Measure (COPM) Baseline Scores
timeFrame: Pre-Intervention
measure: Change between Pre-Intervention and 1-week Post-Intervention Canadian Occupational Performance Measure (COPM) scores
timeFrame: 1-week Post-Intervention
measure: Change between Pre-Intervention and 4-weeks Post-Intervention Canadian Occupational Performance Measure (COPM) scores
timeFrame: 4-weeks Post-Intervention
measure: Change between 1-week and 4-weeks Post-Intervention Canadian Occupational Performance Measure (COPM) scores
timeFrame: 4-weeks Post-Intervention
measure: Shoulder Range of Motion (ROM) Baseline Scores
timeFrame: Pre-Intervention
measure: Change between Pre-Intervention and 1-week Shoulder Range of Motion (ROM) scores
timeFrame: 1-week Post-Intervention
measure: Change between Pre-Intervention and 4-weeks Post-Intervention Shoulder Range of Motion (ROM) scores
timeFrame: 4-weeks Post-Intervention
measure: Change between 1-week and 4-weeks Post-Intervention Shoulder Range of Motion (ROM) scores
timeFrame: 4-weeks Post-Intervention
measure: Jamar Hand Dynamometer Baseline Scores
timeFrame: Pre-Intervention
measure: Change between Pre-Intervention and 1-week Jamar Hand Dynamometer scores
timeFrame: 1-week Post-Intervention
measure: Change between Pre-Intervention and 4-weeks Post-Intervention Jamar Hand Dynamometer scores
timeFrame: 4-weeks Post-Intervention
measure: Change between 1-week and 4-weeks Post-Intervention Jamar Hand Dynamometer Scores
timeFrame: 4-weeks Post-Intervention
measure: Numeric Pain Rating Scale (NPRS) Baseline Scores
timeFrame: Pre-Intervention
measure: Change between Pre-Intervention and 1-week Numeric Pain Rating Scale (NPRS) Scores
timeFrame: 1-week Post-Intervention
measure: Change between Pre-Intervention and 4-weeks Post-Intervention Numeric Pain Rating Scale (NPRS) Scores
timeFrame: 4-weeks Post-Intervention
measure: Change between 1-week and 4-weeks Post-Intervention Numeric Pain Rating Scale (NPRS) scores
timeFrame: 4-weeks Post-Intervention
Other outcomes:
Locations:
city: Jacksonville
country: United States
facility: Bay Path University
state: Florida
Study officials:
affiliation: Bay Path University
name: Kelli A Cabrera
role: PRINCIPAL_INVESTIGATOR
References:
citation: Beaton DE, Wright JG, Katz JN; Upper Extremity Collaborative Group. Development of the QuickDASH: comparison of three item-reduction approaches. J Bone Joint Surg Am. 2005 May;87(5):1038-46. doi: 10.2106/JBJS.D.02060.
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