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NCT Number: NCT04641546

Effectiveness of Occupation-Based Intervention Compared With Therapeutic Exercise for Older Adults With Shoulder OA.

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.

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Key information

Conditions

Osteoarthritis Shoulder

Age range

65 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Bay Path University

Jacksonville, Florida, 32223, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

therapeutic exercise

Procedure

Passive range of motion (PROM), active-assistive range of motion (AAROM), active range of motion (AROM), and strengthening activities.

Occupation-Based Intervention

Procedure

Collecting and placing items in cabinets, washing windows and tables, and hanging clothes on a clothesline.

Primary outcomes

  1. Quick Disabilities of the Arm, Shoulder and Hand (QuickDASH) Baseline scores

    Time frame: Pre-Intervention

    To assess the impact of the intervention on physical function and symptoms of shoulder osteoarthritis.

    • Minimum Value: 0 (no disability)
    • Maximum Value: 100 (most severe disability)
    • Higher scores = Worse outcome (greater upper extremity dysfunction)

  2. Change between Pre-Intervention and 1-week Post-Intervention Quick Disabilities of the Arm, Shoulder and Hand (QuickDASH) scores

    Time frame: 1-week Post-Intervention

    To assess the impact of the intervention on physical function and symptoms of shoulder osteoarthritis.

    • Minimum Value: 0 (no disability)
    • Maximum Value: 100 (most severe disability)
    • Higher scores = Worse outcome (greater upper extremity dysfunction)

  3. Change between Pre-Intervention and 4-weeks Post-Intervention Quick Disabilities of the Arm, Shoulder and Hand (QuickDASH) scores

    Time frame: 4-weeks Post-Intervention

    To assess the impact of the intervention on physical function and symptoms of shoulder osteoarthritis.

    • Minimum Value: 0 (no disability)
    • Maximum Value: 100 (most severe disability)
    • Higher scores = Worse outcome (greater upper extremity dysfunction)

  4. Change between 1-week and 4-weeks Post-Intervention Quick Disabilities of the Arm, Shoulder and Hand (QuickDASH) scores

    Time frame: 4-weeks Post-Intervention

    To assess the impact of the intervention on physical function and symptoms of shoulder osteoarthritis.

    • Minimum Value: 0 (no disability)
    • Maximum Value: 100 (most severe disability)
    • Higher scores = Worse outcome (greater upper extremity dysfunction)

Secondary outcomes

  1. Canadian Occupational Performance Measure (COPM) Baseline Scores

    Time frame: Pre-Intervention

    To determine the effect of the intervention on participants' self-perception of occupational performance and satisfaction over time.

    • Minimum Value: 0
    • Maximum Value: 10
    • Higher scores = Better outcome (greater client-perceived changes in satisfaction and performance of daily occupations)

  2. Change between Pre-Intervention and 1-week Post-Intervention Canadian Occupational Performance Measure (COPM) scores

    Time frame: 1-week Post-Intervention

    To determine the effect of the intervention on participants' self-perception of occupational performance and satisfaction over time.

    • Minimum Value: 0
    • Maximum Value: 10
    • Higher scores = Better outcome (greater client-perceived changes in satisfaction and performance of daily occupations)

  3. Change between Pre-Intervention and 4-weeks Post-Intervention Canadian Occupational Performance Measure (COPM) scores

    Time frame: 4-weeks Post-Intervention

    To determine the effect of the intervention on participants' self-perception of occupational performance and satisfaction over time.

    • Minimum Value: 0
    • Maximum Value: 10
    • Higher scores = Better outcome (greater client-perceived changes in satisfaction and performance of daily occupations)

  4. Change between 1-week and 4-weeks Post-Intervention Canadian Occupational Performance Measure (COPM) scores

    Time frame: 4-weeks Post-Intervention

    To determine the effect of the intervention on participants' self-perception of occupational performance and satisfaction over time.

    • Minimum Value: 0
    • Maximum Value: 10
    • Higher scores = Better outcome (greater client-perceived changes in satisfaction and performance of daily occupations)

  5. Shoulder Range of Motion (ROM) Baseline Scores

    Time frame: Pre-Intervention

    Observing and grading ROM on a 3-point Likert scale to determine shoulder mobility and pain with movement.

    • Minimum Value: 0 (unable/no pain)
    • Maximum Value: 3 (full able/lots of pain)
    • Higher scores = Better outcome (fully ROM/no pain with ROM)

  6. Change between Pre-Intervention and 1-week Shoulder Range of Motion (ROM) scores

    Time frame: 1-week Post-Intervention

    Observing and grading ROM on a 3-point Likert scale to determine shoulder mobility and pain with movement.

    • Minimum Value: 0 (unable/no pain)
    • Maximum Value: 3 (fully able/lots of pain)
    • Higher scores = Better outcome (full ROM/no pain with ROM)

  7. Change between Pre-Intervention and 4-weeks Post-Intervention Shoulder Range of Motion (ROM) scores

    Time frame: 4-weeks Post-Intervention

    Observing and grading ROM on a 3-point Likert scale to determine shoulder mobility and pain with movement.

    • Minimum Value: 0 (unable/no pain)
    • Maximum Value: 3 (fully able/lots of pain)
    • Higher scores = Better outcome (full ROM/no pain with ROM)

  8. Change between 1-week and 4-weeks Post-Intervention Shoulder Range of Motion (ROM) scores

    Time frame: 4-weeks Post-Intervention

    Observing and grading ROM on a 3-point Likert scale to determine shoulder mobility and pain with movement.

    • Minimum Value: 0 (unable/no pain)
    • Maximum Value: 3 (fully able/lots of pain)
    • Higher scores = Better outcome (full ROM/no pain with ROM)

  9. Jamar Hand Dynamometer Baseline Scores

    Time frame: Pre-Intervention

    To measure grip strength.

    • Minimum Value: 0 pounds
    • Maximum Value: 200 pounds
    • Higher scores = Better outcome (increased grip strength)

  10. Change between Pre-Intervention and 1-week Jamar Hand Dynamometer scores

    Time frame: 1-week Post-Intervention

    To measure grip strength.

    • Minimum Value: 0 pounds
    • Maximum Value: 200 pounds
    • Higher scores = Better outcome (increased grip strength)

  11. Change between Pre-Intervention and 4-weeks Post-Intervention Jamar Hand Dynamometer scores

    Time frame: 4-weeks Post-Intervention

    To measure grip strength.

    • Minimum Value: 0 pounds
    • Maximum Value: 200 pounds
    • Higher scores = Better outcome (increased grip strength)

  12. Change between 1-week and 4-weeks Post-Intervention Jamar Hand Dynamometer Scores

    Time frame: 4-weeks Post-Intervention

    To measure grip strength.

    • Minimum Value: 0 pounds
    • Maximum Value: 200 pounds
    • Higher scores = Better outcome (increased grip strength)

  13. Numeric Pain Rating Scale (NPRS) Baseline Scores

    Time frame: Pre-Intervention

    To measure pain.

    • Minimum Value: 0 (no pain)
    • Maximum Value: 10 (worst possible pain)
    • Higher scores = Worse outcome (increased pain)

  14. Change between Pre-Intervention and 1-week Numeric Pain Rating Scale (NPRS) Scores

    Time frame: 1-week Post-Intervention

    To measure pain.

    • Minimum Value: 0 (no pain)
    • Maximum Value: 10 (worst possible pain)
    • Higher scores = Worse outcome (increased pain)

  15. Change between Pre-Intervention and 4-weeks Post-Intervention Numeric Pain Rating Scale (NPRS) Scores

    Time frame: 4-weeks Post-Intervention

    To measure pain.

    • Minimum Value: 0 (no pain)
    • Maximum Value: 10 (worst possible pain)
    • Higher scores = Worse outcome (increased pain)

  16. Change between 1-week and 4-weeks Post-Intervention Numeric Pain Rating Scale (NPRS) scores

    Time frame: 4-weeks Post-Intervention

    To measure pain.

    • Minimum Value: 0 (no pain)
    • Maximum Value: 10 (worst possible pain)
    • Higher scores = Worse outcome (increased pain)

Sponsors and collaborators

Lead sponsor

Bay Path University

Other

Registry information

Official study title

Effectiveness of an Occupation-Based Intervention Compared With Therapeutic Exercise for Older Adults With Shoulder Osteoarthritis: A Pilot Randomized Controlled Trial

Important dates

Study start
2019
Primary completion
2019
Study completion
2020
First posted
Nov 24, 2020
Registry last updated
Nov 24, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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