Knee OsteoarthritisNCT05698368
Digital Knee Osteoarthritis Mindset Intervention
A study testing Mindset intervention and Active comparator in people with Knee Osteoarthritis, run by Stanford University at 1 site in United States.
Trial summary
The aim of our clinical trial is to test if an online mindset intervention improves mindsets and physical activity levels more than an education intervention in individuals with knee osteoarthritis. Read more about this study
- Who is it for?
- Ages 45 years and older
- Conditions the study is for
- Knee Osteoarthritis
- What is being tested?
- Mindset intervention and Active comparator
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 458 participants
- Where
- 1 siteUnited States
- Study dates
- 10 Apr 2023to 19 Sep 2023
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 45 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Over 45 years of age
- Self-reported doctor's diagnosis of knee osteoarthritis OR meets the National Institute for - - Health and Care Excellence osteoarthritis clinical criteria (activity-related knee pain and no knee morning stiffness lasting ≥ 30 minutes)
- Knee pain for at least 3 months
- Ability to walk unaided
- Can read and write in English
- Consistent internet access
- Willingness and ability to comply with the study requirements
Who cannot join
- Past total knee arthroplasty or scheduled surgical procedure on any back or lower limb with osteoarthritis within the next 12 months
- Recent serious injury (within the past 2 months) on the knee(s) with osteoarthritis
- Any condition making it unsafe to participate in physical activity
- Intra-articular therapy within the past 6 months (e.g. injections such as corticosteroids and hyaluronic acid)
- Participates in physical exercise for 30 minutes or more 5 days per week
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Digital Mindset Intervention to Improve Pain and Exercise Participation in Individuals With Knee Osteoarthritis: A Randomized, Parallel-group Study
The aim of our clinical trial is to test if an online mindset intervention improves mindsets and physical activity levels more than an education intervention in individuals with knee osteoarthritis.
Read the detailed description
Osteoarthritis affects 7% of the global population and is a leading cause of disability globally. Physical activity improves health outcomes, weight management, and knee function for people with knee osteoarthritis and should be considered first-line treatment. Yet, physical activity levels in this population are low compared to those without knee osteoarthritis.
Existing knowledge: Emerging research has highlighted the powerful influence of mindsets about exercise on engagement in physical activity. Mindsets are core assumptions about a domain or category that orient individuals to a particular set of attributions, expectations, and goals (a "meaning system"). In individuals with knee osteoarthritis, mindsets about the appeal of physical activity relate to future physical activity levels and one's chosen symptom management strategy, and mindsets about osteoarthritis relate to knee symptoms.
The investigators developed a digital mindset intervention to improve mindsets about exercise and osteoarthritis in individuals with knee osteoarthritis. The investigators piloted the intervention on 21 individuals with knee osteoarthritis throughout the United States. Participants improved in exercise and osteoarthritis mindsets. However, this was a small sample size, a control group was not used, and it was cross-sectional, thus, not able to evaluate changes in physical activity and osteoarthritis symptoms.
Need for a trial: A digital, low-cost, and, thus, scalable intervention to improve mindsets about osteoarthritis and exercise may improve pain and function and physical activity levels for the millions of individuals affected with knee osteoarthritis. A large randomized trial is therefore needed to evaluate if our mindset intervention leads to improvements in physical activity levels and osteoarthritis symptoms and, further, if these changes are due to more adaptive mindsets about exercise and osteoarthritis.
- Conditions
- Knee Osteoarthritis
- Being tested
- Mindset intervention, Active comparator
- Keywords
- Mindset, Physical Activity, Exercise, Psychology, Pain, Digital Health, Osteoarthritis
- Medical subject headings
- Osteoarthritis, Knee, Motor Activity, Pain, Osteoarthritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mindset interventionBehavioural
Participants receive a digital mindset intervention to improve mindsets about osteoarthritis and exercise.
Active comparatorOther
Also called Educational content
Participants receive a series of osteoarthritis education videos and reflective questions that matches the digital mindset intervention in duration and attention.
| Study group | Role | What they receive |
|---|---|---|
| Active comparator group | Active comparator | A series of educational videos and reflective questions of the same duration and required attention as the mindset intervention program. The videos are sourced videos from YouTube that educate about osteoarthritis. The content consists of information about osteoarthritis that patients would typically receive if looking for more information about the disease, including disease pathology, risks, symptoms, and treatment strategies. The included videos contain factual content with a similar format to the mindset intervention videos, including live experts sharing information with animations and supplementary b-roll footage. Receives: Other: Active comparator |
| Mindset intervention group | Experimental | Four modules, each with a series of videos and reflective questions. Each module takes approximately 20-60 minutes to complete, with a total of about two hours to complete the entire program. Participants have one week to complete the program at their own pace. Participants are suggested to complete one module per day but are encouraged to go at the pace that works best for them. Receives: Behavioral: Mindset intervention |
| Waitlist control group | No intervention | This group will take the same surveys as the other groups at the same time points but will not receive any additional content. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change From Baseline in Knee Pain Measured by Numeric Pain Rating Scale
Knee pain scored from 0 - 10 (0 being no pain and 10 being the worst pain)
Measured: Change from Baseline at 1 month
Change From Baseline in Physical Activity Measured by Physical Activity Scale for the Elderly
The Physical Activity Scale for the Elderly (PASE) asks respondents about the frequency of light, moderate, and strenuous work and leisure activities and is a validated measure of self-reported physical activity for individuals with osteoarthritis. The scale is scored from 0 (no physical activity) to 793 (very high physical activity).
Measured: Change from Baseline at 1 month
Change From Baseline in Mindset About the Process of Health - Physical Activity (MPH-Physical Activity) Scale
The Process of Health Mindset -- Exercise measure is a one-factor scale developed and validated to assess mindset about the process of engaging in physical activity (e.g., physical activity is difficult/easy, unpleasant/pleasurable, boring/fun). The scale consists of 7 items scored from 1 to 4, with a higher score reflecting a more appeal-focused mindset about physical activity, and then averaged for a total score between 1 to 4.
Measured: Change from Baseline at Post-intervention (immediately following intervention completion)
Change From Baseline in Osteoarthritis Mindset by the Illness Mindset Inventory
The Illness Mindset Inventory measures three mindsets about the nature and meaning of illness: that it is a catastrophe, manageable, or an opportunity. The scale consists of 20 items measured on a 6-point scale and scored from 1 to 6, with 10 of those questions capturing mindsets about osteoarthritis. The extent to which a participant endorses a particular mindset can be obtained by calculating the mean score for each mindset. A higher score indicates greater agreement with the mindset. The investigators adapted the scale to focus on mindsets about "knee osteoarthritis" as opposed to "chronic disease." There are three subscales, Osteoarthritis is Castrophic, Osteoarthritis is Manageable, and Osteoarthritis is Opportunistic. The questions pertaining to each subscale are averaged for a total score from 1 to 6 for each subscale.
Measured: Change from Baseline at Post-intervention (immediately following intervention completion)
Secondary outcomes (9)
Change From Baseline in Knee Pain and Functioning by the Short Version of Western Ontario and McMaster Universities Arthritis Index (shortMAC)
The short-version of the Western Ontario and McMaster Universities Osteoarthritis Index (ShortMAC) is a disease-specific 12-item measure of knee pain, stiffness, and function. It has been validated and shown to be reliable in patients with knee osteoarthritis. It is measured on the Likert scale and can be divided into two subscales: pain and function. Pain subscore range, 0 (low pain) to 20 (high pain); Function subscore range, 0 (low difficulty) to 28 (high difficulty).
Measured: Change from Baseline at 1 month
Change From Baseline in Knee Osteoarthritis Knowledge by the Knee Osteoarthritis Knowledge Scale
The Knee Osteoarthritis Knowledge Scale is scored from 11-55 and measures knowledge about osteoarthritis in individuals with knee or hip osteoarthritis.
Measured: Change from Baseline at Post-intervention (immediately following intervention completion)
Change From Baseline in Perceived Need for Surgery by a Surgery Perception Question
Perceived need for surgery will be assessed by the single question, "How likely do you think you are of needing knee replacement surgery in the future?" It is answered on the Likert scale from 1 (very unlikely) to 5 (very likely). All items are averaged together for a final score between 1 to 5.
Measured: Change from Baseline at 1 month
Change From Baseline in Symptom Management Strategy by an Osteoarthritis Symptom Management Question. The Variable is Reported as a % of Participants Who Reported Using the Symptom Management Strategy.
Chosen symptom management strategy(ies) will be assessed by the single question, "Which of the following are ways in which you manage and/or improve your osteoarthritis symptoms? Please select all that apply." It is answer via multiple choice with multiple selection option. The options available are the most common strategies as determined by previous studies with an additional option for fill in. The reported value is the percentage of participants that selected the management strategy as a strategy they implement.
Measured: Change from Baseline at 1 month
Change From Baseline in Fear of Movement by the Brief Fear of Movement Scale for Osteoarthritis
The Brief Fear of Movement Scale for Osteoarthritis is a 6-item scale validated to assess fear of movement in individuals with osteoarthritis. All items are averaged for a final score range of 1 (low fear) to 4 (high fear).
Measured: Change from Baseline at 1 month
Change From Baseline in Arthritis Self-efficacy: Pain and Other Symptoms by the Arthritis Self-efficacy Pain and Other Symptoms Subscales
The Arthritis-Self Efficacy Scale is scored from a 1 to 10 with higher scores indicating greater self-efficacy. The scale will be divided into the "pain" and "other symptoms" subscales. The items on each subscale are averaged for a final score from 1 to 10.
Measured: Change from Baseline at 1 month
Change From Baseline in Physical and Mental Health: Global Health: Patient-Reported Outcomes Measurement Information System (PROMIS) Scale v1.2 - Global Health (Physical and Mental Health Sub-scales)
The PROMIS v.1.1 Global Health Short Form is a 10-item survey that measures overall physical function, fatigue, pain, emotional distress, and social health in healthy and clinical adult populations. It will be divided into two subscales: physical health and mental health. The Physical Health subscore ranges from 1 (poor) to 5 (excellent). The Mental Health subscore ranges from 1 (poor) to 5 (excellent).
Measured: Change from Baseline at 1 month
Change From Baseline in Body Mindset by the Illness Mindset Inventory
The Illness Mindset Inventory measures three mindsets about the nature of the body in the context of a chronic illness: that it is adversarial, responsive, or resilient. The scale consists of 20 items measured on a 6-point scale and scored from 1 to 6, with 10 of those questions capturing mindsets about the body. The extent to which a participant endorses a particular mindset can be obtained by calculating the mean score for each mindset. A higher score indicates greater agreement with the mindset. The investigators adapted the scale to focus on mindsets about "knee osteoarthritis" as opposed to "chronic disease." The three subscales are The Body is Adversarial, The Body is Capable, and the Body is Responsive. The items from each subscale are averaged for a final score between 1-6.
Measured: Change from Baseline at Post-intervention (immediately following intervention completion)
Change From Baseline in Adequacy Mindset by the Adequacy of Activity Mindset Measure
The Adequacy of Activity Mindset Measure is a scale developed to assess mindsets about the adequacy and benefits of ones' physical activity as it relates to health. The scale consists of 5 items measured on a 7-point scale and scored from 1 to 7, with a higher score reflecting a more adaptive mindset about the benefits and risks associated with current levels of physical activity. All items are averaged for a final score between 1 to 7.
Measured: Change from Baseline at Post-intervention (immediately following intervention completion)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jan 2023
- Study start10 Apr 2023
- Primary completion19 Sep 2023
- Study completion19 Sep 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (20)Papers the sponsor has linked to this study.
- Other trials for Knee OsteoarthritisStudies of the same condition, open and under way.
- More trials run by Stanford UniversityThe 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants are randomly assigned to one of three groups in parallel for the duration of the study.
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 458 participants (actual)
Sponsor and investigators
- Lead sponsor
- Stanford University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Melissa Boswell, Stanford University
- Investigators
- Melissa Boswell, PhD, Principal investigator, Stanford UniversityScott Delp, PhD, Principal investigator, Stanford UniversityAlia Crum, PhD, Principal investigator, Stanford University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05698368
- Sponsor's protocol ID
- 69227
- Status last verified
- Feb 2025
- First submitted
- 9 Sep 2022
- Last updated
- 13 Feb 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Individual participant data, including participant characteristics and outcome measures, will be made available after de-identification.
Publications
Boswell MA, Evans KM, Zion SR, Boles DZ, Hicks JL, Delp SL, Crum AJ. Mindset is associated with future physical activity and management strategies in individuals with knee osteoarthritis. Ann Phys Rehabil Med. 2022 Nov;65(6):101634. doi: 10.1016/j.rehab.2022.101634. Epub 2022 Apr 28.
PubMed 35091113Hinman RS, Campbell PK, Lawford BJ, Briggs AM, Gale J, Bills C, Kasza J, Harris A, French SD, Bunker SJ, Forbes A, Bennell KL. Does telephone-delivered exercise advice and support by physiotherapists improve pain and/or function in people with knee osteoarthritis? Telecare randomised controlled trial. Br J Sports Med. 2020 Jul;54(13):790-797. doi: 10.1136/bjsports-2019-101183. Epub 2019 Nov 20.
PubMed 31748198Crum AJ, Salovey P, Achor S. Rethinking stress: the role of mindsets in determining the stress response. J Pers Soc Psychol. 2013 Apr;104(4):716-33. doi: 10.1037/a0031201. Epub 2013 Feb 25.
PubMed 23437923Gay C, Guiguet-Auclair C, Mourgues C, Gerbaud L, Coudeyre E. Physical activity level and association with behavioral factors in knee osteoarthritis. Ann Phys Rehabil Med. 2019 Jan;62(1):14-20. doi: 10.1016/j.rehab.2018.09.005. Epub 2018 Oct 2.
PubMed 30290283Fransen M, McConnell S. Exercise for osteoarthritis of the knee. Cochrane Database Syst Rev. 2008 Oct 8;(4):CD004376. doi: 10.1002/14651858.CD004376.pub2.
PubMed 18843657Marks R. Knee osteoarthritis and exercise adherence: a review. Curr Aging Sci. 2012 Feb;5(1):72-83. doi: 10.2174/1874609811205010072.
PubMed 21762086Hunter DJ, March L, Chew M. Osteoarthritis in 2020 and beyond: a Lancet Commission. Lancet. 2020 Nov 28;396(10264):1711-1712. doi: 10.1016/S0140-6736(20)32230-3. Epub 2020 Nov 4. No abstract available.
PubMed 33159851Stanton TR, Karran EL, Butler DS, Hull MJ, Schwetlik SN, Braithwaite FA, Jones HG, Moseley GL, Hill CL, Tomkins-Lane C, Maher C, Bennell K. A pain science education and walking program to increase physical activity in people with symptomatic knee osteoarthritis: a feasibility study. Pain Rep. 2020 Sep 24;5(5):e830. doi: 10.1097/PR9.0000000000000830. eCollection 2020 Sep-Oct.
PubMed 33490835Thorstensson CA, Garellick G, Rystedt H, Dahlberg LE. Better Management of Patients with Osteoarthritis: Development and Nationwide Implementation of an Evidence-Based Supported Osteoarthritis Self-Management Programme. Musculoskeletal Care. 2015 Jun;13(2):67-75. doi: 10.1002/msc.1085. Epub 2014 Oct 24.
PubMed 25345913Pisters MF, Veenhof C, Schellevis FG, De Bakker DH, Dekker J. Long-term effectiveness of exercise therapy in patients with osteoarthritis of the hip or knee: a randomized controlled trial comparing two different physical therapy interventions. Osteoarthritis Cartilage. 2010 Aug;18(8):1019-26. doi: 10.1016/j.joca.2010.05.008. Epub 2010 May 19.
PubMed 20488250Skou ST, Koes BW, Gronne DT, Young J, Roos EM. Comparison of three sets of clinical classification criteria for knee osteoarthritis: a cross-sectional study of 13,459 patients treated in primary care. Osteoarthritis Cartilage. 2020 Feb;28(2):167-172. doi: 10.1016/j.joca.2019.09.003. Epub 2019 Sep 17.
PubMed 31539621Boles DZ, DeSousa M, Turnwald BP, Horii RI, Duarte T, Zahrt OH, Markus HR, Crum AJ. Can Exercising and Eating Healthy Be Fun and Indulgent Instead of Boring and Depriving? Targeting Mindsets About the Process of Engaging in Healthy Behaviors. Front Psychol. 2021 Oct 5;12:745950. doi: 10.3389/fpsyg.2021.745950. eCollection 2021.
PubMed 34712186Washburn RA, Smith KW, Jette AM, Janney CA. The Physical Activity Scale for the Elderly (PASE): development and evaluation. J Clin Epidemiol. 1993 Feb;46(2):153-62. doi: 10.1016/0895-4356(93)90053-4.
PubMed 8437031Abbott JH, Hobbs C, Gwynne-Jones D; MOA Trial Team. The ShortMAC: Minimum Important Change of a Reduced Version of the Western Ontario and McMaster Universities Osteoarthritis Index. J Orthop Sports Phys Ther. 2018 Feb;48(2):81-86. doi: 10.2519/jospt.2018.7676. Epub 2017 Oct 21.
PubMed 29056072Bellamy N, Buchanan WW, Goldsmith CH, Campbell J, Stitt LW. Validation study of WOMAC: a health status instrument for measuring clinically important patient relevant outcomes to antirheumatic drug therapy in patients with osteoarthritis of the hip or knee. J Rheumatol. 1988 Dec;15(12):1833-40.
PubMed 3068365
Study at a glance
From the registry record, last updated by the sponsor on 13 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Digital Mindset Intervention to Improve Pain and Exercise Participation in Individuals With Knee Osteoarthritis: A Randomized, Parallel-group Study
- ClinicalTrials.gov ID
- NCT05698368
- Acronym / sponsor ID
- 69227
- Conditions
- Knee Osteoarthritis
- Keywords
- Mindset, Physical Activity, Exercise, Psychology, Pain, Digital Health, Osteoarthritis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 458 participants (actual)
- Lead sponsor
- Stanford UniversityUniversity, hospital or other
- Study start
- 10 Apr 2023 (actual)
- Primary completion
- 19 Sep 2023 (actual)
- Study completion
- 19 Sep 2023 (actual)
- First posted
- 26 Jan 2023 (actual)
- Results
- Posted 13 Feb 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The aim of our clinical trial is to test if an online mindset intervention improves mindsets and physical activity levels more than an education intervention in individuals with knee osteoarthritis.
Detailed description
Osteoarthritis affects 7% of the global population and is a leading cause of disability globally. Physical activity improves health outcomes, weight management, and knee function for people with knee osteoarthritis and should be considered first-line treatment. Yet, physical activity levels in this population are low compared to those without knee osteoarthritis.
Existing knowledge: Emerging research has highlighted the powerful influence of mindsets about exercise on engagement in physical activity. Mindsets are core assumptions about a domain or category that orient individuals to a particular set of attributions, expectations, and goals (a "meaning system"). In individuals with knee osteoarthritis, mindsets about the appeal of physical activity relate to future physical activity levels and one's chosen symptom management strategy, and mindsets about osteoarthritis relate to knee symptoms.
The investigators developed a digital mindset intervention to improve mindsets about exercise and osteoarthritis in individuals with knee osteoarthritis. The investigators piloted the intervention on 21 individuals with knee osteoarthritis throughout the United States. Participants improved in exercise and osteoarthritis mindsets. However, this was a small sample size, a control group was not used, and it was cross-sectional, thus, not able to evaluate changes in physical activity and osteoarthritis symptoms.
Need for a trial: A digital, low-cost, and, thus, scalable intervention to improve mindsets about osteoarthritis and exercise may improve pain and function and physical activity levels for the millions of individuals affected with knee osteoarthritis. A large randomized trial is therefore needed to evaluate if our mindset intervention leads to improvements in physical activity levels and osteoarthritis symptoms and, further, if these changes are due to more adaptive mindsets about exercise and osteoarthritis.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 3
- Model description
- Participants are randomly assigned to one of three groups in parallel for the duration of the study.
| Arm | Type | Receives |
|---|---|---|
| Active comparator group | Active comparator | Other: Active comparatorA series of educational videos and reflective questions of the same duration and required attention as the mindset intervention program. The videos are sourced videos from YouTube that educate about osteoarthritis. The content consists of information about osteoarthritis that patients would typically receive if looking for more information about the disease, including disease pathology, risks, symptoms, and treatment strategies. The included videos contain factual content with a similar format to the mindset intervention videos, including live experts sharing information with animations and supplementary b-roll footage. |
| Mindset intervention group | Experimental | Behavioral: Mindset interventionFour modules, each with a series of videos and reflective questions. Each module takes approximately 20-60 minutes to complete, with a total of about two hours to complete the entire program. Participants have one week to complete the program at their own pace. Participants are suggested to complete one module per day but are encouraged to go at the pace that works best for them. |
| Waitlist control group | No intervention | –This group will take the same surveys as the other groups at the same time points but will not receive any additional content. |
Who may qualify
- Ages
- 45 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Over 45 years of age
- Self-reported doctor's diagnosis of knee osteoarthritis OR meets the National Institute for - - Health and Care Excellence osteoarthritis clinical criteria (activity-related knee pain and no knee morning stiffness lasting ≥ 30 minutes)
- Knee pain for at least 3 months
- Ability to walk unaided
- Can read and write in English
Key exclusion criteria (5 listed)
- Past total knee arthroplasty or scheduled surgical procedure on any back or lower limb with osteoarthritis within the next 12 months
- Recent serious injury (within the past 2 months) on the knee(s) with osteoarthritis
- Any condition making it unsafe to participate in physical activity
- Intra-articular therapy within the past 6 months (e.g. injections such as corticosteroids and hyaluronic acid)
- Participates in physical exercise for 30 minutes or more 5 days per week
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 |
|---|---|---|
| Mindset interventionParticipants receive a digital mindset intervention to improve mindsets about osteoarthritis and exercise. | Behavioural | Mindset intervention group |
| Active comparatorAlso: Educational contentParticipants receive a series of osteoarthritis education videos and reflective questions that matches the digital mindset intervention in duration and attention. | Other | Active comparator group |
Primary outcome
Change From Baseline in Knee Pain Measured by Numeric Pain Rating Scale
Time frame: Change from Baseline at 1 month
Knee pain scored from 0 - 10 (0 being no pain and 10 being the worst pain)
Change From Baseline in Physical Activity Measured by Physical Activity Scale for the Elderly
Time frame: Change from Baseline at 1 month
The Physical Activity Scale for the Elderly (PASE) asks respondents about the frequency of light, moderate, and strenuous work and leisure activities and is a validated measure of self-reported physical activity for individuals with osteoarthritis. The scale is scored from 0 (no physical activity) to 793 (very high physical activity).
Change From Baseline in Mindset About the Process of Health - Physical Activity (MPH-Physical Activity) Scale
Time frame: Change from Baseline at Post-intervention (immediately following intervention completion)
The Process of Health Mindset -- Exercise measure is a one-factor scale developed and validated to assess mindset about the process of engaging in physical activity (e.g., physical activity is difficult/easy, unpleasant/pleasurable, boring/fun). The scale consists of 7 items scored from 1 to 4, with a higher score reflecting a more appeal-focused mindset about physical activity, and then averaged for a total score between 1 to 4.
Change From Baseline in Osteoarthritis Mindset by the Illness Mindset Inventory
Time frame: Change from Baseline at Post-intervention (immediately following intervention completion)
The Illness Mindset Inventory measures three mindsets about the nature and meaning of illness: that it is a catastrophe, manageable, or an opportunity. The scale consists of 20 items measured on a 6-point scale and scored from 1 to 6, with 10 of those questions capturing mindsets about osteoarthritis. The extent to which a participant endorses a particular mindset can be obtained by calculating the mean score for each mindset. A higher score indicates greater agreement with the mindset. The investigators adapted the scale to focus on mindsets about "knee osteoarthritis" as opposed to "chronic disease." There are three subscales, Osteoarthritis is Castrophic, Osteoarthritis is Manageable, and Osteoarthritis is Opportunistic. The questions pertaining to each subscale are averaged for a total score from 1 to 6 for each subscale.
9 secondary outcomes
Change From Baseline in Knee Pain and Functioning by the Short Version of Western Ontario and McMaster Universities Arthritis Index (shortMAC)
Time frame: Change from Baseline at 1 month
Change From Baseline in Knee Osteoarthritis Knowledge by the Knee Osteoarthritis Knowledge Scale
Time frame: Change from Baseline at Post-intervention (immediately following intervention completion)
Change From Baseline in Perceived Need for Surgery by a Surgery Perception Question
Time frame: Change from Baseline at 1 month
Change From Baseline in Symptom Management Strategy by an Osteoarthritis Symptom Management Question. The Variable is Reported as a % of Participants Who Reported Using the Symptom Management Strategy.
Time frame: Change from Baseline at 1 month
Change From Baseline in Fear of Movement by the Brief Fear of Movement Scale for Osteoarthritis
Time frame: Change from Baseline at 1 month
Change From Baseline in Arthritis Self-efficacy: Pain and Other Symptoms by the Arthritis Self-efficacy Pain and Other Symptoms Subscales
Time frame: Change from Baseline at 1 month
Change From Baseline in Physical and Mental Health: Global Health: Patient-Reported Outcomes Measurement Information System (PROMIS) Scale v1.2 - Global Health (Physical and Mental Health Sub-scales)
Time frame: Change from Baseline at 1 month
Change From Baseline in Body Mindset by the Illness Mindset Inventory
Time frame: Change from Baseline at Post-intervention (immediately following intervention completion)
Change From Baseline in Adequacy Mindset by the Adequacy of Activity Mindset Measure
Time frame: Change from Baseline at Post-intervention (immediately following intervention completion)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Feb 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 35091113Boswell MA, Evans KM, Zion SR, Boles DZ, Hicks JL, Delp SL, Crum AJ. Mindset is associated with future physical activity and management strategies in individuals with knee osteoarthritis. Ann Phys Rehabil Med. 2022 Nov;65(6):101634. doi: 10.1016/j.rehab.2022.101634. Epub 2022 Apr 28.
- Background: PubMed 31748198Hinman RS, Campbell PK, Lawford BJ, Briggs AM, Gale J, Bills C, Kasza J, Harris A, French SD, Bunker SJ, Forbes A, Bennell KL. Does telephone-delivered exercise advice and support by physiotherapists improve pain and/or function in people with knee osteoarthritis? Telecare randomised controlled trial. Br J Sports Med. 2020 Jul;54(13):790-797. doi: 10.1136/bjsports-2019-101183. Epub 2019 Nov 20.
- Background: PubMed 23437923Crum AJ, Salovey P, Achor S. Rethinking stress: the role of mindsets in determining the stress response. J Pers Soc Psychol. 2013 Apr;104(4):716-33. doi: 10.1037/a0031201. Epub 2013 Feb 25.
- Background: PubMed 30290283Gay C, Guiguet-Auclair C, Mourgues C, Gerbaud L, Coudeyre E. Physical activity level and association with behavioral factors in knee osteoarthritis. Ann Phys Rehabil Med. 2019 Jan;62(1):14-20. doi: 10.1016/j.rehab.2018.09.005. Epub 2018 Oct 2.
- Background: PubMed 18843657Fransen M, McConnell S. Exercise for osteoarthritis of the knee. Cochrane Database Syst Rev. 2008 Oct 8;(4):CD004376. doi: 10.1002/14651858.CD004376.pub2.
- Background: PubMed 21762086Marks R. Knee osteoarthritis and exercise adherence: a review. Curr Aging Sci. 2012 Feb;5(1):72-83. doi: 10.2174/1874609811205010072.
- Background: PubMed 33159851Hunter DJ, March L, Chew M. Osteoarthritis in 2020 and beyond: a Lancet Commission. Lancet. 2020 Nov 28;396(10264):1711-1712. doi: 10.1016/S0140-6736(20)32230-3. Epub 2020 Nov 4. No abstract available.
- Background: PubMed 33490835Stanton TR, Karran EL, Butler DS, Hull MJ, Schwetlik SN, Braithwaite FA, Jones HG, Moseley GL, Hill CL, Tomkins-Lane C, Maher C, Bennell K. A pain science education and walking program to increase physical activity in people with symptomatic knee osteoarthritis: a feasibility study. Pain Rep. 2020 Sep 24;5(5):e830. doi: 10.1097/PR9.0000000000000830. eCollection 2020 Sep-Oct.
- Background: PubMed 25345913Thorstensson CA, Garellick G, Rystedt H, Dahlberg LE. Better Management of Patients with Osteoarthritis: Development and Nationwide Implementation of an Evidence-Based Supported Osteoarthritis Self-Management Programme. Musculoskeletal Care. 2015 Jun;13(2):67-75. doi: 10.1002/msc.1085. Epub 2014 Oct 24.
- Background: PubMed 20488250Pisters MF, Veenhof C, Schellevis FG, De Bakker DH, Dekker J. Long-term effectiveness of exercise therapy in patients with osteoarthritis of the hip or knee: a randomized controlled trial comparing two different physical therapy interventions. Osteoarthritis Cartilage. 2010 Aug;18(8):1019-26. doi: 10.1016/j.joca.2010.05.008. Epub 2010 May 19.
- Background: PubMed 31539621Skou ST, Koes BW, Gronne DT, Young J, Roos EM. Comparison of three sets of clinical classification criteria for knee osteoarthritis: a cross-sectional study of 13,459 patients treated in primary care. Osteoarthritis Cartilage. 2020 Feb;28(2):167-172. doi: 10.1016/j.joca.2019.09.003. Epub 2019 Sep 17.
- Background: PubMed 34712186Boles DZ, DeSousa M, Turnwald BP, Horii RI, Duarte T, Zahrt OH, Markus HR, Crum AJ. Can Exercising and Eating Healthy Be Fun and Indulgent Instead of Boring and Depriving? Targeting Mindsets About the Process of Engaging in Healthy Behaviors. Front Psychol. 2021 Oct 5;12:745950. doi: 10.3389/fpsyg.2021.745950. eCollection 2021.
- Individual participant dataSharing planned: Yes. Individual participant data, including participant characteristics and outcome measures, will be made available after de-identification.
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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.
Melissa Boswell, PhD principal investigator
Stanford University
Scott Delp, PhD principal investigator
Stanford University
Alia Crum, PhD principal investigator
Stanford University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mindset intervention and Active comparator in people with Knee Osteoarthritis, run by Stanford University at 1 site in United States.
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 7 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 13 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Yes. Results are posted in the registry (first posted 13 Feb 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Change From Baseline in Knee Pain Measured by Numeric Pain Rating Scale (time frame: Change from Baseline at 1 month). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05698368, which also lists 20 linked publications.
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 13 Feb 2025.