Multimodal physical therapy
Behavioralsee description in arm/group description
NCT Number: NCT04219423
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.
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Notify Me50 year and older
All sexes
Interventional
Not applicable
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
see description in arm/group description
Time frame: 12 weeks
Number of participants enrolled in to the study to determine ability to recruit for the study.
Time frame: 12 weeks
Number of participants who complete the study divided by the number who enroll in the study to determine retention.
Time frame: 12 weeks
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.
Time frame: 12 weeks
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.
Time frame: 12 weeks
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.
Time frame: 12 weeks
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.
Time frame: 12 weeks
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.
Time frame: 12 weeks
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.
Kaiser Permanente
Other
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
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