Clinical trial NCT04219423: Feasibility of Multi-modal Physical Therapy in Latino Older Adults With Moderate Knee Osteoarthritis
Official title: Feasibility and Preliminary Efficacy of Multi-modal Physical Therapy on Physical Performance and Health -Related Quality of Life in Hispanic Older Adults With Moderate Knee Osteoarthritis: a Pilot Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Arthritis Knee
Keywords: Hispanic American
Physical Therapy
Pilot study
Latino
Lead sponsor: Kaiser Permanente
Sponsor class: OTHER
First posted: 2020-01-07
Enrollment: 20
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: This is a small, prospective pre/post evaluation study to determine feasibility for a larger clinical trial. Participants will be recruited from an electronic medical record search and from primary care providers. Recruitment, retention and adherence will be determined. Baseline and post intervention outcomes on physical function and quality of life will be determined for preliminary estimates of change.
Primary purpose: TREATMENT

Brief summary: This is a small, pilot, pre/post evaluation study enrolling older Hispanic American adults with moderate knee arthritis to evaluate the feasibility of recruitment, retention and adherence after a multimodal 12-week, physical therapy intervention. The secondary aim is to evaluate preliminary estimates of change on physical performance and health related quality of life after the intervention.

Detailed description: Background: Hispanic Americans (HAs) experience more pain and mobility deficits associated with knee osteoarthritis (OA) compared to non-Hispanic whites (NHWs) and seek total knee arthroplasties at a reduced rate, thus conservative treatments are needed. Prevalence of knee OA among the older HA population is rising dramatically. There is moderate evidence that lower extremity strengthening, manual therapy and self-management training improve pain and physical performance in people with knee OA and little evidence in the HA population. We conducted a pilot prospective trial implementing a multimodal high intensity targeted strength training, manual therapy and self-management education intervention to evaluate feasibility of recruitment, retention and adherence and preliminary estimates of change on physical performance and health related quality of life (HrQOL) in HAs with moderate knee OA. If this trial is feasible and shows promise for efficacy, it may warrant further testing as a primary treatment for knee OA.

Methods: Spanish speaking older adults will be recruited from Kaiser Permanente San Francisco through a medical record search. Participants will attended 10 physical thearpy clinic visits over 8 weeks, followed by 4 weekly phone calls to assess adherence to exercise via 1-week verbal recall. Participants will be instructed to exercise 3 days per week for the study duration combining both clinic and home exercise participation. The intervention is led in Spanish and will include progressive open and closed-chain quadriceps and gluteal strengthening, progressive cycling training with short power intervals, manual therapy and self-management training.

Eligibility criteria: Inclusion Criteria:

1. Moderate knee osteoarthritis Defined as Kellgren-Lawrence radiographic level 2 or 3
2. People who speak Spanish as a primary language
3. Age 50 or greater
4. pass a Phone screening: Reports problems with physical performance due to knee: Answers yes to 'Are you now limited in any way in any of your usual activities because of arthritis or joint?' Reports pain in their knee: Answers 'yes' to have you had pain in your knee in last 30 days? Be able to walk inside home without a cane, be able to walk ¼ of a block without a cane and be able to go up a flight of stairs without assistance from another

Exclusion Criteria:

1. Psychiatric or behavioral comorbidity preventing participation in a group exercise program
2. History of lower extremity joint arthroplasty
3. Morbid obesity defined as body mass index of 40 or greater
4. Presence of inflammatory arthritic condition
5. Neurologic involvement impacting functional mobility

Primary outcomes:
measure: Number of participants enrolled in the study
timeFrame: 12 weeks
measure: Percentage of enrolled participants at end of study
timeFrame: 12 weeks
measure: Average number of completed exercise session per-week for the study duration.
timeFrame: 12 weeks
Secondary outcomes:
measure: Change in Five-times Sit to Stand (5TSTS) from baseline to after the intervention.
timeFrame: 12 weeks
measure: Change in Six-minute Walk Test (6MWT) from baseline to after the intervention.
timeFrame: 12 weeks
measure: Change in Timed Up and Go (TUG) from baseline to after the intervention.
timeFrame: 12 weeks
measure: Change in absolute isometric bilateral quadriceps strength physical performance measure from baseline to after the intervention.
timeFrame: 12 weeks
measure: Change the Western Ontario McMaster University Osteoarthritis Index (WOMAC) questionnaire score from baseline to after the intervention.
timeFrame: 12 weeks
Other outcomes:
Locations:
Study officials:
affiliation: Kaiser Permanente
name: Amy Gladin
role: PRINCIPAL_INVESTIGATOR
References: