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

NCT04219423 | Completed

• 1 other identifier: CN-16-2740_04
• Study Type: interventional
• Target: 20
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Arthritis Knee

Keywords

Hispanic American; Physical Therapy; Pilot study; Latino

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (5)

• Change in Five-times Sit to Stand (5TSTS) from baseline to after the intervention.

  12 weeks

• Change in Six-minute Walk Test (6MWT) from baseline to after the intervention.

  12 weeks

• Change in Timed Up and Go (TUG) from baseline to after the intervention.

  12 weeks

• Change in absolute isometric bilateral quadriceps strength physical performance measure from baseline to after the intervention.

  12 weeks

• Change the Western Ontario McMaster University Osteoarthritis Index (WOMAC) questionnaire score from baseline to after the intervention.

  12 weeks

Study Arms (1)

multimodal physical therapy

EXPERIMENTAL

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

Interventions

Multimodal physical therapy BEHAVIORAL

see description in arm/group description

multimodal physical therapy

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Moderate knee osteoarthritis Defined as Kellgren-Lawrence radiographic level 2 or 3
• People who speak Spanish as a primary language
• Age 50 or greater
• 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

You may not qualify if:

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

Sponsors & Collaborators

• Kaiser Permanente: lead

Study Officials

• Amy Gladin

  Kaiser Permanente

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Masking Details: Small study staff precludes blinding of assessors and instructors.
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Senior Physical Therapist

Model Details: 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.

Study Record Dates

• First Submitted: December 31, 2019
• First Posted: January 7, 2020
• Study Start: April 10, 2016
• Primary Completion: January 31, 2017
• Study Completion: January 31, 2017
• Last Updated: January 7, 2020

Record last verified: 2020-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, CSR
• Time Frame: December 20 2019 to December 31 2020.
• Access Criteria: Investigators or clinicians can have access to the study intervention protocol or a de-identified data set on outcome measures.