Arthritis KneeNCT04219423
Feasibility of Multi-modal Physical Therapy in Latino Older Adults With Moderate Knee Osteoarthritis
A study testing Multimodal physical therapy in people with Arthritis Knee, run by Kaiser Permanente.
Trial 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. Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Arthritis Knee
- What is being tested?
- Multimodal physical therapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- No sites listed yet
- Study dates
- 10 Apr 2016to 31 Jan 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
About this study
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
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.
Read the 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
- Being tested
- Multimodal physical therapy
- Keywords
- Hispanic American, Physical Therapy, Pilot study, Latino
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Multimodal physical therapyBehavioural
see description in arm/group description
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Behavioral: Multimodal physical therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants enrolled in the study
Number of participants enrolled in to the study to determine ability to recruit for the study.
Measured: 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.
Measured: 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.
Measured: 12 weeks
Secondary outcomes (5)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jan 2020
- Study start10 Apr 2016
- Primary completion31 Jan 2017
- Study completion31 Jan 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Arthritis KneeStudies of the same condition, open and under way.
- More trials run by Kaiser PermanenteThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- 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.
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kaiser Permanente
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Amy Gladin, Kaiser Permanente
- Investigators
- Amy Gladin, Principal investigator, Kaiser Permanente
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04219423
- Sponsor's protocol ID
- CN-16-2740_04
- Status last verified
- Jan 2020
- First submitted
- 31 Dec 2019
- Last updated
- 7 Jan 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Investigators may have a PDF copy of the study protocol upon request or a de-identified data set upon request.
Study at a glance
From the registry record, last updated by the sponsor on 7 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04219423
- Acronym / sponsor ID
- CN-16-2740_04
- Conditions
- Arthritis Knee
- Keywords
- Hispanic American, Physical Therapy, Pilot study, Latino
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Kaiser PermanenteUniversity, hospital or other
- Study start
- 10 Apr 2016 (actual)
- Primary completion
- 31 Jan 2017 (actual)
- Study completion
- 31 Jan 2017 (actual)
- First posted
- 7 Jan 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- 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.
| Arm | Type | Receives |
|---|---|---|
| multimodal physical therapy | Experimental | Behavioral: Multimodal physical therapyThe 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 |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Multimodal physical therapysee description in arm/group description | Behavioural | multimodal physical therapy |
Primary outcome
Number of participants enrolled in the study
Time frame: 12 weeks
Number of participants enrolled in to the study to determine ability to recruit for the study.
Percentage of enrolled participants at end of study
Time frame: 12 weeks
Number of participants who complete the study divided by the number who enroll in the study to determine retention.
Average number of completed exercise session per-week for the study duration.
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.
5 secondary outcomes
Change in Five-times Sit to Stand (5TSTS) from baseline to after the intervention.
Time frame: 12 weeks
Change in Six-minute Walk Test (6MWT) from baseline to after the intervention.
Time frame: 12 weeks
Change in Timed Up and Go (TUG) from baseline to after the intervention.
Time frame: 12 weeks
Change in absolute isometric bilateral quadriceps strength physical performance measure from baseline to after the intervention.
Time frame: 12 weeks
Change the Western Ontario McMaster University Osteoarthritis Index (WOMAC) questionnaire score from baseline to after the intervention.
Time frame: 12 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jan 2020.
- Individual participant dataSharing planned: Yes. Investigators may have a PDF copy of the study protocol upon request or a de-identified data set upon request.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Amy Gladin principal investigator
Kaiser Permanente
Questions about this trial
What is this clinical trial studying?
A study testing Multimodal physical therapy in people with Arthritis Knee, run by Kaiser Permanente.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Jan 2020. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of participants enrolled in the study (time frame: 12 weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Jan 2020.