Knee OsteoarthritisNCT06580561
Move and Snooze: Adding Insomnia Treatment to an Exercise Program to Improve Pain Outcomes in Older Adults With Knee Osteoarthritis
A study testing Personalized exercise coaching and Cognitive behavioral therapy for Insomnia in people with Knee Osteoarthritis and Insomnia, run by University of Michigan at 1 site in United States.
Trial summary
This research will compare the effectiveness of a remotely delivered personalized exercise coaching plus an evidence-based sleep improvement intervention to remotely delivered personalized exercise coaching alone for knee osteoarthritis pain. Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Knee Osteoarthritis, Insomnia
- What is being tested?
- Personalized exercise coaching and Cognitive behavioral therapy for Insomnia
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 288 participants
- Where
- 1 siteUnited States
- Study dates
- 4 Nov 2024to 31 Aug 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- Self-reported physician diagnosis of knee osteoarthritis
- Persistent knee osteoarthritis-related pain of at least moderate intensity (as indicated in the protocol)
- Indication of persistent symptoms of insomnia, determined by scoring on the Sleep Condition Indicator questionnaire (as indicated in the protocol)
- If receiving medication for pain or sleep disturbances, having had no change in prescription in the previous three months and be willing to make no other changes to medications for pain or sleep during the active study period.
- Adequate literacy level to ensure web-based surveys can be completed independently, as assessed using a brief 3-item literacy level screener
Who cannot join
- Concurrent diagnosis of a systemic, inflammatory musculoskeletal disorder (e.g., rheumatoid arthritis)
- Active malignancy
- Neurological conditions (e.g., movement disorders)
- Any medical condition which would make graded increase of physical activity unsuitable (determined by a positive answer to the question: "Has a doctor or healthcare professional advised you to avoid physical activity for any reason?").
- Unable to understand English sufficiently to take part in the intervention.
- Unable to provide electronic informed consent.
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- Evidence of significant cognitive impairment (i.e., ≥2 errors on a 6-item cognitive screener).
- Presence of severe psychiatric disorder.
- Currently participating in an interventional trial or a pain or sleep management program or having done so in the past six months.
- Visual or hearing impairment that would prevent use of the intervention.
- Serious physical health concerns necessitating surgery or with a prognosis <6 months
- Irregular sleep-wake schedule, e.g., shift work.
- Self-report of diagnosis of a specific sleep disorder other than insomnia that is not currently adequately treated, e.g., sleep apnea or narcolepsy.
- Currently meeting or exceeding physical activity guidance from the U.S. Department of Health and Human Services (noted in protocol)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
University of Michigan
Ann Arbor, Michigan, 48109
Jade Treder, 734-936-2844, trederj@med.umich.edu
Daniel Whibley, PhD
About this study
This research will compare the effectiveness of a remotely delivered personalized exercise coaching plus an evidence-based sleep improvement intervention to remotely delivered personalized exercise coaching alone for knee osteoarthritis pain.
The study team hypothesize that the combined intervention will result in greater improvements in patient-reported pain intensity, recorded with real-time data capture, than remotely delivered exercise coaching alone.
- Conditions
- Knee Osteoarthritis, Insomnia
- Being tested
- Personalized exercise coaching, Cognitive behavioral therapy for Insomnia
- Keywords
- Exercise coaching, Cognitive behavioral therapy
- Medical subject headings
- Osteoarthritis, Knee, Sleep Initiation and Maintenance Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Personalized exercise coachingBehavioural
This is a 6-session personalized exercise coaching program (delivered over 8 weeks).
All participants will complete six 30-minute scheduled online or phone sessions with a health coach as part of a manualized personalized exercise program (once per week for the first four sessions and then once every two weeks for the remaining two sessions).
Cognitive behavioral therapy for InsomniaBehavioural
This is a 6-week course of automated, digitally delivered cognitive behavioral therapy for insomnia delivered by the online program Sleepio. The weekly sessions will last approximately 15-20 minutes.
Session content comprises evidence-based cognitive and behavioral techniques including Stimulus Control Therapy and Sleep Restriction Therapy, sleep hygiene education, and relaxation exercises.
| Study group | Role | What they receive |
|---|---|---|
| Move and Snooze program | Experimental | This includes the personalized exercise program plus Cognitive Behavioral Therapy for Insomnia (CBT-I). Receives: Behavioral: Personalized exercise coaching; Behavioral: Cognitive behavioral therapy for Insomnia |
| Personalized exercise program | Experimental | Not described Receives: Behavioral: Personalized exercise coaching |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in average pain intensity using a 0-10 numerical rating scale between baseline and the 8-week follow-up (post-intervention) period
This is a one question numerical rating scale in which participants select from 0 (no pain) -10 (worst pain imaginable) numerical rating scale 4 times a day over 7 days during each assessment period (baseline and 8-week follow-up). These four within-day ratings collected over seven days will be averaged for each participant to provide a single pain intensity rating for each assessment period.
Measured: Baseline, 8-week follow-up (post-intervention)
Secondary outcomes (5)
Change in the Patient Reported Outcomes Measurement Information System (PROMIS) Pain Intensity 3a questionnaire between baseline and 8-week follow-up (post-intervention)
There are 3 questions that participants answer and from no pain (1) - very severe (5). There is a total score of 15 with a higher score indicating higher pain intensity.
Measured: Baseline, 8-week (post-intervention)
Change in the PROMIS Pain Interference 8a questionnaire between baseline and 8-week follow-up (post-intervention)
There are 8 questions regarding the extent to which pain has interfered with activities over the past 7 days, ranging from not at all (1) - Very much (5). Total scores range from 8 to 40, with a higher score representing higher interference due to pain.
Measured: Baseline, 8-week (post-intervention)
Change in the PROMIS Physical Function questionnaire between baseline and 8-week follow-up (post-intervention)
There are 4 questions regarding function that participants answer and from without any difficulty (5) - unable to do (1). And 4 questions for that participants select from not at all (5) to cannot do (1). There is a total score of 40 with a higher score indicating greater physical function.
Measured: Baseline, 8-week (post-intervention)
Change in the Quality of Life subscale of the Knee injury and Osteoarthritis Outcome Score (KOOS) between baseline and 8-week follow-up (post-intervention)
The KOOS quality of life subscale includes 4 questions. The Score subscale is scored using a Likert scale with five possible answers, ranging from 0 (no problems) to 4 (extreme problems). The quality of life subscale score is then normalized to a 0-100 scale, with higher scores equaling better status. 0 represents extreme knee problems and 100 represents no knee problems.
Measured: Baseline, 8-week (post-intervention)
Patient Global Impression of Change at 8-week follow-up (post-intervention)
This is a one question survey that participants will select from very much improved (1) -very much worse (7) since the start of the study and overall status. A lower number indicates better outcome.
Measured: 8-week (post-intervention)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Aug 2024
- Study start4 Nov 2024
- Primary completion29 Feb 2028 (estimated)
- Study completion31 Aug 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Knee OsteoarthritisStudies of the same condition, open and under way.
- More trials run by University of MichiganThe 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
- Randomised
- Intervention model
- Parallel groups
- Model description
- Enrolled participants will be randomized in blocks, stratified by biological sex, age, and baseline pain intensity (per protocol)
- Masking
- None (open label)
- Enrolment
- 288 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Michigan
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Aging (NIA)
- Responsible party
- Principal investigator, Daniel Whibley, University of Michigan
- Investigators
- Daniel Whibley, PhD, Principal investigator, University of Michigan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06580561
- Sponsor's protocol ID
- HUM00241352
- Other IDs
- 1R01AG081299-01A1
- Status last verified
- Apr 2026
- First submitted
- 29 Aug 2024
- Last updated
- 13 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: After the study is completed, the de-identified, archived data will be transmitted to and stored at the Inter-university Consortium for Political and Social Research data repository.
Study at a glance
From the registry record, last updated by the sponsor on 13 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Move and Snooze: Adding Insomnia Treatment to an Exercise Program to Improve Pain Outcomes in Older Adults With Knee Osteoarthritis
- ClinicalTrials.gov ID
- NCT06580561
- Acronym / sponsor ID
- HUM00241352
- Conditions
- Knee Osteoarthritis, Insomnia
- Keywords
- Exercise coaching, Cognitive behavioral therapy
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 288 participants (estimated)
- Lead sponsor
- University of MichiganUniversity, hospital or other
- Collaborators
- National Institute on Aging (NIA)
- Study start
- 4 Nov 2024 (actual)
- Primary completion
- 29 Feb 2028 (estimated)
- Study completion
- 31 Aug 2028 (estimated)
- First posted
- 30 Aug 2024 (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 research will compare the effectiveness of a remotely delivered personalized exercise coaching plus an evidence-based sleep improvement intervention to remotely delivered personalized exercise coaching alone for knee osteoarthritis pain.
The study team hypothesize that the combined intervention will result in greater improvements in patient-reported pain intensity, recorded with real-time data capture, than remotely delivered exercise coaching alone.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Enrolled participants will be randomized in blocks, stratified by biological sex, age, and baseline pain intensity (per protocol)
| Arm | Type | Receives |
|---|---|---|
| Move and Snooze program | Experimental | Behavioral: Personalized exercise coaching, Behavioral: Cognitive behavioral therapy for InsomniaThis includes the personalized exercise program plus Cognitive Behavioral Therapy for Insomnia (CBT-I). |
| Personalized exercise program | Experimental | Behavioral: Personalized exercise coaching |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Self-reported physician diagnosis of knee osteoarthritis
- Persistent knee osteoarthritis-related pain of at least moderate intensity (as indicated in the protocol)
- Indication of persistent symptoms of insomnia, determined by scoring on the Sleep Condition Indicator questionnaire (as indicated in the protocol)
- If receiving medication for pain or sleep disturbances, having had no change in prescription in the previous three months and be willing to make no other changes to medications for pain or sleep during the active study period.
- Adequate literacy level to ensure web-based surveys can be completed independently, as assessed using a brief 3-item literacy level screener
Key exclusion criteria (14 listed)
- Concurrent diagnosis of a systemic, inflammatory musculoskeletal disorder (e.g., rheumatoid arthritis)
- Active malignancy
- Neurological conditions (e.g., movement disorders)
- Any medical condition which would make graded increase of physical activity unsuitable (determined by a positive answer to the question: "Has a doctor or healthcare professional advised you to avoid physical activity for any reason?").
- Unable to understand English sufficiently to take part in the intervention.
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 |
|---|---|---|
| Personalized exercise coachingThis is a 6-session personalized exercise coaching program (delivered over 8 weeks). All participants will complete six 30-minute scheduled online or phone sessions with a health coach as part of a manualized personalized exercise program (once per week for the first four sessions and then once every two weeks for the remaining two sessions). | Behavioural | Move and Snooze program, Personalized exercise program |
| Cognitive behavioral therapy for InsomniaThis is a 6-week course of automated, digitally delivered cognitive behavioral therapy for insomnia delivered by the online program Sleepio. The weekly sessions will last approximately 15-20 minutes. Session content comprises evidence-based cognitive and behavioral techniques including Stimulus Control Therapy and Sleep Restriction Therapy, sleep hygiene education, and relaxation exercises. | Behavioural | Move and Snooze program |
Primary outcome
Change in average pain intensity using a 0-10 numerical rating scale between baseline and the 8-week follow-up (post-intervention) period
Time frame: Baseline, 8-week follow-up (post-intervention)
This is a one question numerical rating scale in which participants select from 0 (no pain) -10 (worst pain imaginable) numerical rating scale 4 times a day over 7 days during each assessment period (baseline and 8-week follow-up). These four within-day ratings collected over seven days will be averaged for each participant to provide a single pain intensity rating for each assessment period.
5 secondary outcomes
Change in the Patient Reported Outcomes Measurement Information System (PROMIS) Pain Intensity 3a questionnaire between baseline and 8-week follow-up (post-intervention)
Time frame: Baseline, 8-week (post-intervention)
Change in the PROMIS Pain Interference 8a questionnaire between baseline and 8-week follow-up (post-intervention)
Time frame: Baseline, 8-week (post-intervention)
Change in the PROMIS Physical Function questionnaire between baseline and 8-week follow-up (post-intervention)
Time frame: Baseline, 8-week (post-intervention)
Change in the Quality of Life subscale of the Knee injury and Osteoarthritis Outcome Score (KOOS) between baseline and 8-week follow-up (post-intervention)
Time frame: Baseline, 8-week (post-intervention)
Patient Global Impression of Change at 8-week follow-up (post-intervention)
Time frame: 8-week (post-intervention)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Apr 2026.
- Individual participant dataSharing planned: Yes. After the study is completed, the de-identified, archived data will be transmitted to and stored at the Inter-university Consortium for Political and Social Research data repository.
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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.
Daniel Whibley, PhD principal investigator
University of Michigan
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Personalized exercise coaching and Cognitive behavioral therapy for Insomnia in people with Knee Osteoarthritis and Insomnia, run by University of Michigan 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 5 inclusion and 14 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: looking for participants now, as of the sponsor's last update on 13 Apr 2026. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jade Treder (734-936-2844, trederj@med.umich.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in average pain intensity using a 0-10 numerical rating scale between baseline and the 8-week follow-up (post-intervention) period (time frame: Baseline, 8-week follow-up (post-intervention)). 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 13 Apr 2026.