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

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

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.

Study Overview

• Status: Completed
• Conditions: Arthritis Knee
• Intervention / Treatment: Behavioral: Multimodal physical therapy

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.

• Study Type: Interventional
• Enrollment (Actual): 20
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 48 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: 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

Behavioral: Multimodal physical therapy; see description in arm/group description

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of participants enrolled in the study	Number of participants enrolled in to the study to determine ability to recruit for the study.	12 weeks
Percentage of enrolled participants at end of study	Number of participants who complete the study divided by the number who enroll in the study to determine retention.	12 weeks
Average number of completed exercise session per-week for the study duration.	Number of clinic session attendance plus the number of self-reported participation in home exercise divided by the study goal of exercising 3 days per week for the 12 week study duration (36 exercise sessions total) yielding a percentage to determine adherence to the exercise intervention.	12 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Five-times Sit to Stand (5TSTS) from baseline to after the intervention.	5TSTS is a physical performance measure and is the time in seconds it takes for participants to stand up and sit down from a chair 5 times as fast as possible. Shorter duration in seconds indicates improved physical performance.	12 weeks
Change in Six-minute Walk Test (6MWT) from baseline to after the intervention.	6MWT is a physical performance measure and is the distance in meters participants are able to walk for 6 minutes at self-selected speed. Shorter distance in meters indicates improved physical performance.	12 weeks
Change in Timed Up and Go (TUG) from baseline to after the intervention.	Timed up and go (TUG) is a physical performance measure and is measured in seconds, the time it takes for participants to rise from a chair, walk 10-meters at their 'normal' speed and return to a sitting position. Shorter duration in seconds indicates improved physical performance.	12 weeks
Change in absolute isometric bilateral quadriceps strength physical performance measure from baseline to after the intervention.	Absolute isometric quadriceps strength is a physical performance measure and is measured in pounds and normalized to body weight and expressed as a percentage. Quadriceps strength is measured in a sitting position, with participants knee bent to 90 degrees. The examiner stabilizes a hand-held dynamometer on a table leg with a gait-belt strap and aligns the hand held dynamometer 1 inch proximal to the distal fibula on the anterior aspect of the tibia underneath the gait belt. Participants are given 2 to 3 practice sessions on 1 minute rests. Participants are given verbal encouragement to push as hard as they can for 2 trials on 1 minute rests and the average peak force in pounds is recorded. Increased peak force normalized to body-weight percentage indicates improvement in quadriceps strength.	12 weeks
Change the Western Ontario McMaster University Osteoarthritis Index (WOMAC) questionnaire score from baseline to after the intervention.	The Western Ontario McMaster University Osteoarthritis Index (WOMAC) is a self-administered questionnaire that measures health-related quality of life in people with lower extremity dysfunction. The WOMAC has 24 questions in total and aggregates constructs of pain (5 questions), stiffness (2 questions) and physical function (17 questions) yielding a maximum score of 96 points. Each question is scored 0 to 4 where 0 indicates 'none' and 4 indicates 'extreme'. Higher scores indicate worse pain, stiffness and physical function. Each construct can be scored separately to represent a single construct.	12 weeks

Collaborators and Investigators

• Sponsor: Kaiser Permanente
• Investigators: Principal Investigator: Amy Gladin, Kaiser Permanente

Study record dates

Study Major Dates

• Study Start (Actual): April 10, 2016
• Primary Completion (Actual): January 31, 2017
• Study Completion (Actual): January 31, 2017

Study Registration Dates

• First Submitted: December 31, 2019
• First Submitted That Met QC Criteria: January 3, 2020
• First Posted (Actual): January 7, 2020

Study Record Updates

• Last Update Posted (Actual): January 7, 2020
• Last Update Submitted That Met QC Criteria: January 3, 2020
• Last Verified: January 1, 2020

More Information

Terms related to this study

• Keywords: Physical Therapy; Pilot study; Latino; Hispanic American
• Additional Relevant MeSH Terms: Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Arthritis; Osteoarthritis; Osteoarthritis, Knee
• Other Study ID Numbers: CN-16-2740_04

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Yes
• IPD Plan Description: Investigators may have a PDF copy of the study protocol upon request or a de-identified data set upon request.
• IPD Sharing Time Frame: December 20 2019 to December 31 2020.
• IPD Sharing Access Criteria: Investigators or clinicians can have access to the study intervention protocol or a de-identified data set on outcome measures.
• IPD Sharing Supporting Information Type: Study Protocol; Clinical Study Report (CSR)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No