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NCT05524116: TEMPO

Telehealth Exercise and Mindfulness for Pain in Osteoarthritis

Completed NA Results posted Last updated 16 January 2025
What this trial tests

NA trial testing Mindful Exercise program in Knee Osteoarthritis in 45 participants. Completed in 3 July 2023.

Timeline
4 October 2022
Primary endpoint
6 June 2023
3 July 2023

Quick facts

Lead sponsorBoston University Charles River Campus
PhaseNA
StatusCompleted
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingsingle
Primary purposetreatment
Enrollment45
Start date4 October 2022
Primary completion6 June 2023
Estimated completion3 July 2023
Sites1 location across United States

Drugs / interventions tested

Conditions studied

Sponsor

Boston University Charles River Campus

Who can join

50 and older, any sex, with Knee Osteoarthritis. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Recruitment Primary · through the recruitment process, up to 6 months from the start of the study

Number of participants that are randomized for the study

GroupValue95% CI
Group TX (Telehealth Exercise)19
Group TMX (Telehealth Exercise and Mindfulness)21
Attendance Primary · post-intervention (at 8-weeks)

Proportion of sessions attended

GroupValue95% CI
Group TX (Telehealth Exercise)68± 34
Group TMX (Telehealth Exercise and Mindfulness)54± 39
Retention Rate Primary · post-intervention visit (at the end of 8-weeks)

Proportion of participants who complete patient-reported outcome surveys

GroupValue95% CI
Group TX (Telehealth Exercise)19
Group TMX (Telehealth Exercise and Mindfulness)18
Participant Feedback Survey Primary · 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)

The exercise instructor demonstrated good knowledge
GroupValue95% CI
Group TX (Telehealth Exercise)3.562 – 4
Group TMX (Telehealth Exercise and Mindfulness)3.292 – 4
The exercise instructor was a good role model
GroupValue95% CI
Group TX (Telehealth Exercise)3.442 – 4
Group TMX (Telehealth Exercise and Mindfulness)3.352 – 4
The exercise instructor explained lessons clearly
GroupValue95% CI
Group TX (Telehealth Exercise)3.331 – 4
Group TMX (Telehealth Exercise and Mindfulness)3.382 – 4
The exercise instructor was engaging
GroupValue95% CI
Group TX (Telehealth Exercise)3.392 – 4
Group TMX (Telehealth Exercise and Mindfulness)3.442 – 4
The exercise instructor was helpful/answered all questions
GroupValue95% CI
Group TX (Telehealth Exercise)3.331 – 4
Group TMX (Telehealth Exercise and Mindfulness)3.442 – 4
I enjoyed the exercise lessons
GroupValue95% CI
Group TX (Telehealth Exercise)3.111 – 4
Group TMX (Telehealth Exercise and Mindfulness)2.881 – 4
I was engaged in the exercise lessons
GroupValue95% CI
Group TX (Telehealth Exercise)3.391 – 4
Group TMX (Telehealth Exercise and Mindfulness)3.122 – 4
I was able to understand the exercise lessons
GroupValue95% CI
Group TX (Telehealth Exercise)3.562 – 4
Group TMX (Telehealth Exercise and Mindfulness)3.242 – 4
Satisfaction Scale Primary · 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.

Exercise component
GroupValue95% CI
Group TX (Telehealth Exercise)8.12.0 – 10.0
Group TMX (Telehealth Exercise and Mindfulness)8.25.0 – 10.0
Mindfulness Component
GroupValue95% CI
Group TMX (Telehealth Exercise and Mindfulness)7.32.0 – 10.0
Telehealth component
GroupValue95% CI
Group TX (Telehealth Exercise)8.11.0 – 10.0
Group TMX (Telehealth Exercise and Mindfulness)7.95.0 – 10.0
General participation
GroupValue95% CI
Group TX (Telehealth Exercise)7.91.0 – 10.0
Group TMX (Telehealth Exercise and Mindfulness)8.15.0 – 10.0
Knee Injury and Osteoarthritis Outcome Score Secondary · baseline, 8-week, 14-week

Patient-reported outcome for knee pain and disability; a percentage score from 0 to 100, 0 representing extreme problems and 100 representing no problems.

Pain Baseline
GroupValue95% CI
Group TX (Telehealth Exercise)61.357.6 – 64.9
Group TMX (Telehealth Exercise and Mindfulness)57.752.6 – 62.7
Pain Week-8
GroupValue95% CI
Group TX (Telehealth Exercise)63.757.9 – 69.5
Group TMX (Telehealth Exercise and Mindfulness)61.854.4 – 69.1
Pain Week-14
GroupValue95% CI
Group TX (Telehealth Exercise)63.857.3 – 70.3
Group TMX (Telehealth Exercise and Mindfulness)64.257 – 71.4
Symptoms Baseline
GroupValue95% CI
Group TX (Telehealth Exercise)59.754.3 – 65
Group TMX (Telehealth Exercise and Mindfulness)59.453.9 – 65
Symptoms Week-8
GroupValue95% CI
Group TX (Telehealth Exercise)63.158.5 – 67.8
Group TMX (Telehealth Exercise and Mindfulness)59.953.7 – 66.1
Symptoms Week-14
GroupValue95% CI
Group TX (Telehealth Exercise)68.863 – 74.5
Group TMX (Telehealth Exercise and Mindfulness)62.154 – 70.3
Activity of Daily Living Baseline
GroupValue95% CI
Group TX (Telehealth Exercise)72.166.7 – 77.6
Group TMX (Telehealth Exercise and Mindfulness)6357.8 – 68.1
Activity of Daily Living Week-8
GroupValue95% CI
Group TX (Telehealth Exercise)72.666.4 – 78.8
Group TMX (Telehealth Exercise and Mindfulness)68.260.3 – 76.1
Pain, Enjoyment, General Activity Scale Secondary · baseline, 8-week, 14-week

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.

Baseline
GroupValue95% CI
Group TX (Telehealth Exercise)4.94.2 – 5.6
Group TMX (Telehealth Exercise and Mindfulness)5.44.6 – 6.1
Week-8
GroupValue95% CI
Group TX (Telehealth Exercise)42.9 – 5
Group TMX (Telehealth Exercise and Mindfulness)3.93 – 4.7
Week-14
GroupValue95% CI
Group TX (Telehealth Exercise)3.92.9 – 4.9
Group TMX (Telehealth Exercise and Mindfulness)3.42.5 – 4.4
Numeric Rating Scale - Nominated Activity Secondary · baseline, 8-week, 14-week

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

Baseline
GroupValue95% CI
Group TX (Telehealth Exercise)6.15.3 – 6.9
Group TMX (Telehealth Exercise and Mindfulness)6.56.1 – 6.9
Week-8
GroupValue95% CI
Group TX (Telehealth Exercise)5.14 – 6.2
Group TMX (Telehealth Exercise and Mindfulness)5.24.4 – 5.9
Week-14
GroupValue95% CI
Group TX (Telehealth Exercise)4.83.8 – 5.9
Group TMX (Telehealth Exercise and Mindfulness)4.83.8 – 5.7
Participant Global Impression of Change Secondary · 8-week, 14-week

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.

Week-8
GroupValue95% CI
Group TX (Telehealth Exercise)2.21 – 3.4
Group TMX (Telehealth Exercise and Mindfulness)2.41.2 – 3.7
Week-14
GroupValue95% CI
Group TX (Telehealth Exercise)1.40.1 – 2.7
Group TMX (Telehealth Exercise and Mindfulness)2.21.1 – 3.3
Patient Global Assessment of Osteoarthritis Secondary · baseline, 8-week, 14-week

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

Baseline
GroupValue95% CI
Group TX (Telehealth Exercise)59.849.2 – 70.4
Group TMX (Telehealth Exercise and Mindfulness)63.754.7 – 72.6
Week-8
GroupValue95% CI
Group TX (Telehealth Exercise)64.554.5 – 74.5
Group TMX (Telehealth Exercise and Mindfulness)65.756.9 – 74.5
Week-14
GroupValue95% CI
Group TX (Telehealth Exercise)60.250.8 – 69.5
Group TMX (Telehealth Exercise and Mindfulness)68.760.7 – 76.7
Pain Catastrophizing Scale Secondary · baseline, 8-week

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).

Baseline
GroupValue95% CI
Group TX (Telehealth Exercise)3.52.7 – 4.4
Group TMX (Telehealth Exercise and Mindfulness)3.92.9 – 4.9
Week-8
GroupValue95% CI
Group TX (Telehealth Exercise)3.42.3 – 4.6
Group TMX (Telehealth Exercise and Mindfulness)3.12 – 4.1
Widespread Pain Index Symptom Severity Scale Secondary · baseline, 8-week

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.

Baseline
GroupValue95% CI
Group TX (Telehealth Exercise)3.93 – 4.8
Group TMX (Telehealth Exercise and Mindfulness)3.12.2 – 4.1
Week-8
GroupValue95% CI
Group TX (Telehealth Exercise)4.12.9 – 5.3
Group TMX (Telehealth Exercise and Mindfulness)3.72.6 – 4.9

Adverse events — posted to ClinicalTrials.gov

Time frame: 14-weeks. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Group TX (Telehealth Exercise)
Serious: 0/19 (0%)
Deaths: 0/19
Group TMX (Telehealth Exercise and Mindfulness)
Serious: 0/21 (0%)
Deaths: 0/21
Other adverse events (6 terms — click to expand)

ReactionSystemGroup TX (Telehealth Exerc…Group TMX (Telehealth Exer…
Exacerbation of knee painMusculoskeletal and connective tissue disorders——
FluInfections and infestations——
Hernia surgerySurgical and medical procedures——
Ankle injuryMusculoskeletal and connective tissue disorders——
Knee replacement surgerySurgical and medical procedures——
Generally feeling unwellGeneral disorders——

Data from ClinicalTrials.gov NCT05524116 adverse events section.

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

  1. Telehealth mindful exercise for people with knee osteoarthritis: A decentralized feasibility randomized controlled trial.
    Shah N, Morone N, Kim E, Ellis TD, et al · · 2024 · cited 6× · PMID 39021877 · DOI 10.1016/j.ocarto.2024.100494

Verify or expand the search:

Other recruiting trials for Knee Osteoarthritis

Currently open trials in the same condition.

Other Boston University Charles River Campus trials

Trials by the same sponsor.

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Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05524116.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing