Knee OsteoarthritisTEMPONCT05524116
Telehealth Exercise and Mindfulness for Pain in Osteoarthritis
A study testing Mindful Exercise program and Exercise in people with Knee Osteoarthritis, run by Boston University Charles River Campus at 1 site in United States.
Trial summary
This is a parallel-arm mixed-methods randomized controlled trial to investigate the feasibility of telehealth delivered mindful exercise vs. usual exercise interventions for people with knee osteoarthritis. Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Knee Osteoarthritis
- What is being tested?
- Mindful Exercise program and Exercise
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- 1 siteUnited States
- Study dates
- 4 Oct 2022to 3 Jul 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 50 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Meet National Institute for Health and Clinical Excellence clinical guidelines for knee osteoarthritis (i.e., age ≥ 50 years, presence of activity related pain, presence of morning knee stiffness ≤ 30 minutes)
- BMI<40
- Knee pain on most days for 3 months or more
- Average overall knee pain severity of ≥= 4 on a 11-point numeric rating scale during previous week
- Able to attend remote sessions
- Can speak and understand English at a sufficient level to understand the study procedures and informed consent.
- Available for study duration
Who cannot join
- Contraindications to exercise
- Other pain in lower back or legs that is greater than knee pain
- Received physical therapy treatment for knee OA in the past 6 months or currently receiving physical therapy
- Received any mindfulness programs such as Tai Chi, meditation, etc. in the past 6 months or currently receiving such program
- Currently receiving chemotherapy or radiation therapy for cancer except non-melanoma skin cancer
- History of other disease that may involve the index joint including inflammatory joint disease such as rheumatoid arthritis, seronegative spondyloarthropathy (eg, ankylosing spondylitis, psoriatic arthritis, inflammatory bowel disease related arthropathy), crystalline disease (eg, gout or pseudogout), lupus erythematosus, knee joint infections, Paget's disease affecting the knee, or knee joint tumors.
Show all 16Show fewer
- Any knee surgery in the previous 6 months
- Joint replacement in either hip or ankle
- Previous knee osteotomy partial or total knee replacement in either knee
- Planned major treatment for knee OA (e.g., surgery, injections, physical therapy) during the study period
- Planned major surgery in the next 6 months
- Corticosteroid or hyaluronic acid injections in either knee in the previous 3 months
- Neurological conditions that impacts motor functioning (e.g., stroke, Parkinson's disease, Alzheimer's disease, Multiple Sclerosis, diabetic neuropathy, etc).
- Pregnancy (self-report)
- Participation in another clinical trial for any joint or muscle pain
- Suspected or known drugs or alcohol abuse
Trial locations and contacts
1 site in 1 country.
United States1 site
Movement and Applied Imaging Lab, Boston University
Boston, Massachusetts, 02215
About this study
Official title: Telehealth Exercise and Mindfulness for Pain in Osteoarthritis: A Feasibility Study
This is a parallel-arm mixed-methods randomized controlled trial to investigate the feasibility of telehealth delivered mindful exercise vs. usual exercise interventions for people with knee osteoarthritis.
Read the detailed description
In this RCT, the feasibility of an 8-week telehealth mindful exercise intervention compared to an 8-week telehealth exercise only intervention for people with knee osteoarthritis (OA) will be assessed. Forty adults with knee OA will be assigned to either a mindful exercise arm OR exercise arm. Both interventions will be delivered via real-time videoconferencing in a group setting (n=8-10 per group). All participants will be administered questionnaires for self-reported symptoms, mood, quality of life, etc. throughout the study period. Participants will be given the choice to opt in for in-person data collection visits wherein their physical function, muscle strength, sensitivity to painful stimuli, and brain function will be assessed before and at the end of the interventions. At the end of the 8-week interventions, 10 participants will be purposively sampled from each arm (n=20 total) for individual interviews to determine acceptability of the telehealth interventions. Feasibility of the intervention will be determined post-intervention by outcome measures such as recruitment rate, retention rate, and adherence.
- Conditions
- Knee Osteoarthritis
- Being tested
- Mindful Exercise program, Exercise
- Keywords
- telehealth, exercise, mindfulness, pain, feasibility
- Medical subject headings
- Osteoarthritis, Knee, Motor Activity, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mindful Exercise programBehavioural
In this 8-week intervention, components of Mindful Based Stress Reduction Program will be integrated with strengthening and neuromuscular exercises recommended for knee osteoarthritis. The goal of this program is to train participants how to be mindful during their exercises.
ExerciseBehavioural
In this 8-week intervention, participants will be given recommended strengthening and neuromuscular exercises for knee osteoarthritis. Participants in both the intervention and control group will receive these exercises.
| Study group | Role | What they receive |
|---|---|---|
| Group TX (Telehealth Exercise) | Active comparator | Participants in this group will receive a supervised and group-based exercise program once a week for 8 weeks via telehealth. Receives: Behavioral: Exercise |
| Group TMX (Telehealth Exercise and Mindfulness) | Experimental | Participants in this group will receive a supervised, group-based integrated mindfulness and exercise program once a week for 8 weeks via telehealth. Receives: Behavioral: Mindful Exercise program |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recruitment
Number of participants that are randomized for the study
Measured: through the recruitment process, up to 6 months from the start of the study
Attendance
Proportion of sessions attended
Measured: post-intervention (at 8-weeks)
Retention Rate
Proportion of participants who complete patient-reported outcome surveys
Measured: post-intervention visit (at the end of 8-weeks)
Participant Feedback Survey
Custom scale measuring feedback on interventionists and interventions. Scores range from 0-4 (0 - Strongly Disagree, 1 - Disagree, 2 - Neither Agree no Disagree, 3 - Agree, and 4 - Strongly Agree)
Measured: 8-week
Satisfaction Scale
Custom 4-item (0-10 scale) to determine satisfaction with individual components of the intervention (i.e.,, exercise, mindfulness, telehealth, and overall satisfaction). There are 4 items and each item is scored separately. Higher scores for each item mean greater satisfaction for that dimension.
Measured: 8-week
Secondary outcomes (13)
Knee Injury and Osteoarthritis Outcome Score
Patient-reported outcome for knee pain and disability; a percentage score from 0 to 100, 0 representing extreme problems and 100 representing no problems.
Measured: baseline, 8-week, 14-week
Pain, Enjoyment, General Activity Scale
Assesses Pain Intensity and Interference. the response range is 0-10; the PEG scale score is the mean of the three individual item scores. Higher scores represent worse pain.
Measured: baseline, 8-week, 14-week
Numeric Rating Scale - Nominated Activity
average rating of knee pain from 0-10, where 0 represents no pain and 10 represents worst pain imaginable, in the past week in a nominated activity selected at baseline
Measured: baseline, 8-week, 14-week
Participant Global Impression of Change
participant's rating of change in condition on a 14-point scale ranging from "a very great deal worse" to "a very great deal better". Values range from -7 to +7 (excluding 0). Score >=1 represent improvement and scores <= -1 represent worsening.
Measured: 8-week, 14-week
Patient Global Assessment of Osteoarthritis
participant's assessment of impact of osteoarthritis on their general health on a 0-100 mm scale. higher scores represent higher impact of disease or worse global health
Measured: baseline, 8-week, 14-week
Pain Catastrophizing Scale
3-item scale which measures of catastrophizing related to pain. Each item is rated on a 5-point scale: 0 (Not at all) to 4 (all the time).
Measured: baseline, 8-week
Widespread Pain Index Symptom Severity Scale
self-report on severity of cognitive symptoms such as fatigue, trouble thinking or remembering, waking up tired, and other physical symptoms such as headache, dizziness, etc. Each symptom is scored on a 4-point scale where 0 indicates no problem and 3 indicates severe problem. Scores are calculated by summing items, with higher scores (out of a maximum score of 12) indicating greater symptom severity.
Measured: baseline, 8-week
Pain DETECT
self-report measure on presence of neuropathic pain. each question is scored from 0 to 5 where higher scores indicate higher gradation of pain. The final score is between -1 and 38 and a score of 19 and higher indicates higher likelihood of neuropathic pain
Measured: baseline, 8-week
Patient Health Questionnaire 8-item
8-item questionnaire assessing depression symptoms. Each question is scored from 0 to 3 where higher scores indicate higher frequency of experiencing depressive symptoms. Total score is the sum of individual item scores. Score range is 0-24. Higher total scores indicate greater severity of depression
Measured: baseline, 8-week, 14-week
Cognitive and Affective Mindfulness Scale - Revised
12-item scale on dispositional mindfulness. Items are rated on a 4-point Likert scale from 1 (rarely/not at all) to 4 (almost always). Scores on the scale are summed. Higher scores reflect greater mindfulness.
Measured: baseline, 8-week, 14-week
Fear Avoidance Beliefs Questionnaire - Physical Activity
4-item questionnaire to determine how one's fear avoidance beliefs contributes to the cognitive/affective part of their knee pain. Each item is scored from 0 to 6. Total scores are summation of each item scores. Range is 0-24. Higher total scores indicate greater fear of physical activity
Measured: baseline, 8-week
Arthritis Self Efficacy Scale
Questionnaire to assess confidence in one's capacity to function despite pain. Each item in the questionnaire is scored on a 1-10 scale. It provides three subscales of pain, function, and other symptoms calculated as average of items contributing to that subscale. Range for each subscale is 1-10. Higher scores indicate greater self-efficacy to manage osteoarthritis.
Measured: baseline, 8-week
Chronic Pain Self-efficacy Questionnaire
Measures three domains of pain self-efficacy: pain management, physical functioning, and coping with symptoms. Each item is scored on a scale of 0 (very uncertain) to 100 (very certain). Score for each domain is the average of all items contributing to that domain. Higher total scores indicate greater self-efficacy to manage one's chronic pain.
Measured: baseline, 8-week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Sep 2022
- Study start4 Oct 2022
- Primary completion6 Jun 2023
- Study completion3 Jul 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.
- Other trials for Knee OsteoarthritisStudies of the same condition, open and under way.
- 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
- Parallel-arm randomized controlled trial
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- Boston University Charles River Campus
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Deepak Kumar, Boston University Charles River Campus
- Investigators
- Deepak Kumar, PT, PhD, Principal investigator, Boston University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05524116
- Sponsor's protocol ID
- 6492
- Acronym
- TEMPO
- Status last verified
- Nov 2024
- First submitted
- 25 Aug 2022
- Last updated
- 16 Jan 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Requests will be considered on an individual basis
Study at a glance
From the registry record, last updated by the sponsor on 16 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Telehealth Exercise and Mindfulness for Pain in Osteoarthritis: A Feasibility Study
- ClinicalTrials.gov ID
- NCT05524116
- Acronym / sponsor ID
- TEMPO / 6492
- Conditions
- Knee Osteoarthritis
- Keywords
- telehealth, exercise, mindfulness, pain, feasibility
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- Boston University Charles River CampusUniversity, hospital or other
- Study start
- 4 Oct 2022 (actual)
- Primary completion
- 6 Jun 2023 (actual)
- Study completion
- 3 Jul 2023 (actual)
- First posted
- 1 Sep 2022 (actual)
- Results
- Posted 16 Jan 2025
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 parallel-arm mixed-methods randomized controlled trial to investigate the feasibility of telehealth delivered mindful exercise vs. usual exercise interventions for people with knee osteoarthritis.
Detailed description
In this RCT, the feasibility of an 8-week telehealth mindful exercise intervention compared to an 8-week telehealth exercise only intervention for people with knee osteoarthritis (OA) will be assessed. Forty adults with knee OA will be assigned to either a mindful exercise arm OR exercise arm. Both interventions will be delivered via real-time videoconferencing in a group setting (n=8-10 per group). All participants will be administered questionnaires for self-reported symptoms, mood, quality of life, etc. throughout the study period. Participants will be given the choice to opt in for in-person data collection visits wherein their physical function, muscle strength, sensitivity to painful stimuli, and brain function will be assessed before and at the end of the interventions. At the end of the 8-week interventions, 10 participants will be purposively sampled from each arm (n=20 total) for individual interviews to determine acceptability of the telehealth interventions. Feasibility of the intervention will be determined post-intervention by outcome measures such as recruitment rate, retention rate, and adherence.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Parallel-arm randomized controlled trial
| Arm | Type | Receives |
|---|---|---|
| Group TX (Telehealth Exercise) | Active comparator | Behavioral: ExerciseParticipants in this group will receive a supervised and group-based exercise program once a week for 8 weeks via telehealth. |
| Group TMX (Telehealth Exercise and Mindfulness) | Experimental | Behavioral: Mindful Exercise programParticipants in this group will receive a supervised, group-based integrated mindfulness and exercise program once a week for 8 weeks via telehealth. |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Meet National Institute for Health and Clinical Excellence clinical guidelines for knee osteoarthritis (i.e., age ≥ 50 years, presence of activity related pain, presence of morning knee stiffness ≤ 30 minutes)
- BMI<40
- Knee pain on most days for 3 months or more
- Average overall knee pain severity of ≥= 4 on a 11-point numeric rating scale during previous week
- Able to attend remote sessions
Key exclusion criteria (16 listed)
- Contraindications to exercise
- Other pain in lower back or legs that is greater than knee pain
- Received physical therapy treatment for knee OA in the past 6 months or currently receiving physical therapy
- Received any mindfulness programs such as Tai Chi, meditation, etc. in the past 6 months or currently receiving such program
- Currently receiving chemotherapy or radiation therapy for cancer except non-melanoma skin cancer
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 |
|---|---|---|
| Mindful Exercise programIn this 8-week intervention, components of Mindful Based Stress Reduction Program will be integrated with strengthening and neuromuscular exercises recommended for knee osteoarthritis. The goal of this program is to train participants how to be mindful during their exercises. | Behavioural | Group TMX (Telehealth Exercise and Mindfulness) |
| ExerciseIn this 8-week intervention, participants will be given recommended strengthening and neuromuscular exercises for knee osteoarthritis. Participants in both the intervention and control group will receive these exercises. | Behavioural | Group TX (Telehealth Exercise) |
Primary outcome
Recruitment
Time frame: through the recruitment process, up to 6 months from the start of the study
Number of participants that are randomized for the study
Attendance
Time frame: post-intervention (at 8-weeks)
Proportion of sessions attended
Retention Rate
Time frame: post-intervention visit (at the end of 8-weeks)
Proportion of participants who complete patient-reported outcome surveys
Participant Feedback Survey
Time frame: 8-week
Custom scale measuring feedback on interventionists and interventions. Scores range from 0-4 (0 - Strongly Disagree, 1 - Disagree, 2 - Neither Agree no Disagree, 3 - Agree, and 4 - Strongly Agree)
Satisfaction Scale
Time frame: 8-week
Custom 4-item (0-10 scale) to determine satisfaction with individual components of the intervention (i.e.,, exercise, mindfulness, telehealth, and overall satisfaction). There are 4 items and each item is scored separately. Higher scores for each item mean greater satisfaction for that dimension.
13 secondary outcomes
Knee Injury and Osteoarthritis Outcome Score
Time frame: baseline, 8-week, 14-week
Pain, Enjoyment, General Activity Scale
Time frame: baseline, 8-week, 14-week
Numeric Rating Scale - Nominated Activity
Time frame: baseline, 8-week, 14-week
Participant Global Impression of Change
Time frame: 8-week, 14-week
Patient Global Assessment of Osteoarthritis
Time frame: baseline, 8-week, 14-week
Pain Catastrophizing Scale
Time frame: baseline, 8-week
Widespread Pain Index Symptom Severity Scale
Time frame: baseline, 8-week
Pain DETECT
Time frame: baseline, 8-week
Patient Health Questionnaire 8-item
Time frame: baseline, 8-week, 14-week
Cognitive and Affective Mindfulness Scale - Revised
Time frame: baseline, 8-week, 14-week
Fear Avoidance Beliefs Questionnaire - Physical Activity
Time frame: baseline, 8-week
Arthritis Self Efficacy Scale
Time frame: baseline, 8-week
Chronic Pain Self-efficacy Questionnaire
Time frame: baseline, 8-week
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jan 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No. Requests will be considered on an individual basis
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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.
Deepak Kumar, PT, PhD principal investigator
Boston 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 Mindful Exercise program and Exercise in people with Knee Osteoarthritis, run by Boston University Charles River Campus 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 16 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 16 Jan 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 16 Jan 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?
Recruitment (time frame: through the recruitment process, up to 6 months from the start of the study). The study lists 5 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 16 Jan 2025.