Feasibility of Multi-modal Physical Therapy in Latino Older Adults With Moderate Knee Osteoarthritis

NCT ID: NCT04219423

Last Updated: 2020-01-07

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-04-10
• Study Completion Date: 2017-01-31

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.

Conditions

Arthritis Knee

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

multimodal physical therapy

The multimodal intervention is 75 minutes in duration and meets two days per week for two weeks, then once per week for six weeks, followed by weekly phone calls to determine adherence to home-exercise program (HEP) for four weeks. The total duration of the intervention is twelve weeks. The intervention will be led in a group format with a ratio of one physical therapist to two participants and groups never exceeding 4 participants. All verbal and written communications in the intervention will be conducted in Spanish. The multimodal intervention consists of progressive lower extremity strengthening training targeting the quadriceps and gluteal groups in both legs, progressive stationary bicycle exercise, self-management training and education, manual therapy and home exercise program (HEP) instruction. Participants are asked to do their strengthening exercises at least three days per week for the 12-week study duration including sessions in the clinic

Group Type: EXPERIMENTAL

Multimodal physical therapy

Intervention Type: BEHAVIORAL

see description in arm/group description

Interventions

Multimodal physical therapy

see description in arm/group description

Intervention Type: BEHAVIORAL

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

• Minimum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Kaiser Permanente

OTHER

Sponsor Role: lead

Responsible Party

Amy Gladin

Senior Physical Therapist

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Amy Gladin

Role: PRINCIPAL_INVESTIGATOR

Kaiser Permanente

Other Identifiers

CN-16-2740_04

Identifier Type: -

Identifier Source: org_study_id