Trial Outcomes & Findings for Telehealth Exercise and Mindfulness for Pain in Osteoarthritis (NCT NCT05524116)

Results Overview

Number of participants that are randomized for the study

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

45 participants

Primary outcome timeframe

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

Results posted on

2025-01-16

Participant Flow

A total of 45 participants were enrolled (i.e., signed the consent form) and 40 of these were randomized to Group TX (n=19) or Group TMX (n=21). Five participants withdrew from the study prior to randomization due to work schedule changes (n=2), severe back pain (n=1), family emergency (n=1), and lack of motivation (n=1).

Participant milestones

Participant milestones
Measure	Group TX (Telehealth Exercise) Participants in this group will receive a supervised and group-based exercise program once a week for 8 weeks via telehealth. Exercise: 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.	Group TMX (Telehealth Exercise and Mindfulness) Participants in this group will receive a supervised, group-based integrated mindfulness and exercise program once a week for 8 weeks via telehealth. Mindful Exercise program: 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.
Baseline to Postintervention (Week 8) STARTED	19	21
Baseline to Postintervention (Week 8) COMPLETED	19	18
Baseline to Postintervention (Week 8) NOT COMPLETED	0	3
Week 8 to Follow-up (Week 14) STARTED	19	18
Week 8 to Follow-up (Week 14) COMPLETED	18	17
Week 8 to Follow-up (Week 14) NOT COMPLETED	1	1

Reasons for withdrawal

Reasons for withdrawal
Measure	Group TX (Telehealth Exercise) Participants in this group will receive a supervised and group-based exercise program once a week for 8 weeks via telehealth. Exercise: 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.	Group TMX (Telehealth Exercise and Mindfulness) Participants in this group will receive a supervised, group-based integrated mindfulness and exercise program once a week for 8 weeks via telehealth. Mindful Exercise program: 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.
Baseline to Postintervention (Week 8) Brain tumor flare up	0	1
Baseline to Postintervention (Week 8) concussion	0	1
Baseline to Postintervention (Week 8) hernia surgery	0	1
Week 8 to Follow-up (Week 14) Caregiver for sick family member	1	0
Week 8 to Follow-up (Week 14) Lost to Follow-up	0	1

Baseline Characteristics

Telehealth Exercise and Mindfulness for Pain in Osteoarthritis

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Group TX (Telehealth Exercise) n=19 Participants Participants in this group will receive a supervised and group-based exercise program once a week for 8 weeks via telehealth. Exercise: 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.	Group TMX (Telehealth Exercise and Mindfulness) n=21 Participants Participants in this group will receive a supervised, group-based integrated mindfulness and exercise program once a week for 8 weeks via telehealth. Mindful Exercise program: 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.	Total n=40 Participants Total of all reporting groups
Age, Continuous	67.4 years STANDARD_DEVIATION 7.4 • n=5 Participants	63.8 years STANDARD_DEVIATION 8.9 • n=7 Participants	65.5 years STANDARD_DEVIATION 8.3 • n=5 Participants
Sex: Female, Male Female	17 Participants n=5 Participants	18 Participants n=7 Participants	35 Participants n=5 Participants
Sex: Female, Male Male	2 Participants n=5 Participants	3 Participants n=7 Participants	5 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) White	18 Participants n=5 Participants	19 Participants n=7 Participants	37 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Education High school or College 1 - 3 years	6 Participants n=5 Participants	8 Participants n=7 Participants	14 Participants n=5 Participants
Education Undergraduate, graduate, or doctorate	13 Participants n=5 Participants	13 Participants n=7 Participants	26 Participants n=5 Participants
Annual income More than 50,000$	10 Participants n=5 Participants	11 Participants n=7 Participants	21 Participants n=5 Participants
Annual income Less than 50,000$	8 Participants n=5 Participants	9 Participants n=7 Participants	17 Participants n=5 Participants
Annual income Did not report	1 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants
Marital Status Married	9 Participants n=5 Participants	10 Participants n=7 Participants	19 Participants n=5 Participants
Marital Status Widowed, divorced, single, or not reported	10 Participants n=5 Participants	11 Participants n=7 Participants	21 Participants n=5 Participants

PRIMARY outcome

Timeframe: through the recruitment process, up to 6 months from the start of the study

Population: A total of 40 randomized over 6 months (Oct 2022 - March 2023)

Number of participants that are randomized for the study

Outcome measures

Outcome measures
Measure	Group TX (Telehealth Exercise) n=19 Participants Participants in this group will receive a supervised and group-based exercise program once a week for 8 weeks via telehealth. Exercise: 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.	Group TMX (Telehealth Exercise and Mindfulness) n=21 Participants Participants in this group will receive a supervised, group-based integrated mindfulness and exercise program once a week for 8 weeks via telehealth. Mindful Exercise program: 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.
Recruitment	19 Participants	21 Participants

PRIMARY outcome

Timeframe: post-intervention (at 8-weeks)

Proportion of sessions attended

Outcome measures

Outcome measures
Measure	Group TX (Telehealth Exercise) n=19 Participants Participants in this group will receive a supervised and group-based exercise program once a week for 8 weeks via telehealth. Exercise: 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.	Group TMX (Telehealth Exercise and Mindfulness) n=21 Participants Participants in this group will receive a supervised, group-based integrated mindfulness and exercise program once a week for 8 weeks via telehealth. Mindful Exercise program: 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.
Attendance	68 % sessions attended Standard Deviation 34	54 % sessions attended Standard Deviation 39

PRIMARY outcome

Timeframe: post-intervention visit (at the end of 8-weeks)

Proportion of participants who complete patient-reported outcome surveys

Outcome measures

Outcome measures
Measure	Group TX (Telehealth Exercise) n=19 Participants Participants in this group will receive a supervised and group-based exercise program once a week for 8 weeks via telehealth. Exercise: 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.	Group TMX (Telehealth Exercise and Mindfulness) n=21 Participants Participants in this group will receive a supervised, group-based integrated mindfulness and exercise program once a week for 8 weeks via telehealth. Mindful Exercise program: 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.
Retention Rate	19 Participants	18 Participants

PRIMARY outcome

Timeframe: 8-week

Population: On the 19 participants randomized to TX group, 18 provided data for this outcome at week 8. Of the 21 participants assigned to the TMX group, 17 provided data for this outcome at week 8. Since the TX group did not receive any mindfulness training, outcome related to rating of the mindfulness intervention or instructor were not collected for this group.

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)

Outcome measures

Outcome measures
Measure	Group TX (Telehealth Exercise) n=18 Participants Participants in this group will receive a supervised and group-based exercise program once a week for 8 weeks via telehealth. Exercise: 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.	Group TMX (Telehealth Exercise and Mindfulness) n=17 Participants Participants in this group will receive a supervised, group-based integrated mindfulness and exercise program once a week for 8 weeks via telehealth. Mindful Exercise program: 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.
Participant Feedback Survey The exercise instructor was a good role model	3.44 score on a scale Interval 2.0 to 4.0	3.35 score on a scale Interval 2.0 to 4.0
Participant Feedback Survey The exercise instructor explained lessons clearly	3.33 score on a scale Interval 1.0 to 4.0	3.38 score on a scale Interval 2.0 to 4.0
Participant Feedback Survey The exercise instructor was engaging	3.39 score on a scale Interval 2.0 to 4.0	3.44 score on a scale Interval 2.0 to 4.0
Participant Feedback Survey The exercise instructor was helpful/answered all questions	3.33 score on a scale Interval 1.0 to 4.0	3.44 score on a scale Interval 2.0 to 4.0
Participant Feedback Survey I enjoyed the exercise lessons	3.11 score on a scale Interval 1.0 to 4.0	2.88 score on a scale Interval 1.0 to 4.0
Participant Feedback Survey I was engaged in the exercise lessons	3.39 score on a scale Interval 1.0 to 4.0	3.12 score on a scale Interval 2.0 to 4.0
Participant Feedback Survey I was able to understand the exercise lessons	3.56 score on a scale Interval 2.0 to 4.0	3.24 score on a scale Interval 2.0 to 4.0
Participant Feedback Survey I was able to integrate the information from the different exercise lessons	3.39 score on a scale Interval 2.0 to 4.0	3.19 score on a scale Interval 2.0 to 4.0
Participant Feedback Survey I will be able to use the exercise lessons in my life	3.22 score on a scale Interval 0.0 to 4.0	3.25 score on a scale Interval 2.0 to 4.0
Participant Feedback Survey The mindfulness instructor demonstrated good knowledge	—	3.35 score on a scale Interval 2.0 to 4.0
Participant Feedback Survey The mindfulness instructor was a good role model	—	3.35 score on a scale Interval 2.0 to 4.0
Participant Feedback Survey The mindfulness instructor explained lessons clearly	—	3.24 score on a scale Interval 2.0 to 4.0
Participant Feedback Survey The mindfulness instructor was engaging	—	3.29 score on a scale Interval 2.0 to 4.0
Participant Feedback Survey The mindfulness instructor was helpful/answered all questions	—	3.29 score on a scale Interval 2.0 to 4.0
Participant Feedback Survey I enjoyed the mindfulness lessons	—	2.71 score on a scale Interval 1.0 to 4.0
Participant Feedback Survey I was engaged in the mindfulness lessons	—	3.12 score on a scale Interval 2.0 to 4.0
Participant Feedback Survey I was able to integrate the information from the different mindfulness lessons	—	3.24 score on a scale Interval 2.0 to 4.0
Participant Feedback Survey I will be able to use the mindfulness lessons in my life	—	3 score on a scale Interval 2.0 to 4.0
Participant Feedback Survey The exercise instructor demonstrated good knowledge	3.56 score on a scale Interval 2.0 to 4.0	3.29 score on a scale Interval 2.0 to 4.0
Participant Feedback Survey I was able to understand the mindfulness lessons	—	3.12 score on a scale Interval 1.0 to 4.0

PRIMARY outcome

Timeframe: 8-week

Population: On the 19 participants randomized to TX group, 18 provided data for this outcome at week 8. Of the 21 participants assigned to the TMX group, 17 provided data for this outcome at week 8. TX group did not receive the mindfulness intervention so the mindfulness item on this scale was not administered to this group

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.

Outcome measures

Outcome measures
Measure	Group TX (Telehealth Exercise) n=18 Participants Participants in this group will receive a supervised and group-based exercise program once a week for 8 weeks via telehealth. Exercise: 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.	Group TMX (Telehealth Exercise and Mindfulness) n=17 Participants Participants in this group will receive a supervised, group-based integrated mindfulness and exercise program once a week for 8 weeks via telehealth. Mindful Exercise program: 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.
Satisfaction Scale Exercise component	8.1 score on a scale Interval 2.0 to 10.0	8.2 score on a scale Interval 5.0 to 10.0
Satisfaction Scale General participation	7.9 score on a scale Interval 1.0 to 10.0	8.1 score on a scale Interval 5.0 to 10.0
Satisfaction Scale Mindfulness Component	—	7.3 score on a scale Interval 2.0 to 10.0
Satisfaction Scale Telehealth component	8.1 score on a scale Interval 1.0 to 10.0	7.9 score on a scale Interval 5.0 to 10.0

SECONDARY outcome

Timeframe: baseline, 8-week, 14-week

Population: On the 19 participants randomized to TX group, 18 provided data for this outcome at week 8 and week 14. Of the 21 participants assigned to the TMX group, 17 provided data for this outcome at week 8 and week 14.

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

Outcome measures

Outcome measures
Measure	Group TX (Telehealth Exercise) n=19 Participants Participants in this group will receive a supervised and group-based exercise program once a week for 8 weeks via telehealth. Exercise: 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.	Group TMX (Telehealth Exercise and Mindfulness) n=21 Participants Participants in this group will receive a supervised, group-based integrated mindfulness and exercise program once a week for 8 weeks via telehealth. Mindful Exercise program: 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.
Knee Injury and Osteoarthritis Outcome Score Pain Baseline	61.3 score on a scale Interval 57.6 to 64.9	57.7 score on a scale Interval 52.6 to 62.7
Knee Injury and Osteoarthritis Outcome Score Pain Week-8	63.7 score on a scale Interval 57.9 to 69.5	61.8 score on a scale Interval 54.4 to 69.1
Knee Injury and Osteoarthritis Outcome Score Pain Week-14	63.8 score on a scale Interval 57.3 to 70.3	64.2 score on a scale Interval 57.0 to 71.4
Knee Injury and Osteoarthritis Outcome Score Symptoms Baseline	59.7 score on a scale Interval 54.3 to 65.0	59.4 score on a scale Interval 53.9 to 65.0
Knee Injury and Osteoarthritis Outcome Score Symptoms Week-8	63.1 score on a scale Interval 58.5 to 67.8	59.9 score on a scale Interval 53.7 to 66.1
Knee Injury and Osteoarthritis Outcome Score Symptoms Week-14	68.8 score on a scale Interval 63.0 to 74.5	62.1 score on a scale Interval 54.0 to 70.3
Knee Injury and Osteoarthritis Outcome Score Activity of Daily Living Baseline	72.1 score on a scale Interval 66.7 to 77.6	63 score on a scale Interval 57.8 to 68.1
Knee Injury and Osteoarthritis Outcome Score Sports and Recreation Baseline	48.1 score on a scale Interval 37.5 to 58.6	37.4 score on a scale Interval 31.1 to 43.7
Knee Injury and Osteoarthritis Outcome Score Sports and Recreation Week-8	47.2 score on a scale Interval 34.2 to 60.3	40.6 score on a scale Interval 32.4 to 48.7
Knee Injury and Osteoarthritis Outcome Score Quality Of Life Week-14	52.1 score on a scale Interval 46.4 to 57.8	52.6 score on a scale Interval 44.4 to 60.7
Knee Injury and Osteoarthritis Outcome Score Activity of Daily Living Week-8	72.6 score on a scale Interval 66.4 to 78.8	68.2 score on a scale Interval 60.3 to 76.1
Knee Injury and Osteoarthritis Outcome Score Activity of Daily Living Week-14	71.4 score on a scale Interval 64.2 to 78.7	68.5 score on a scale Interval 62.4 to 74.6
Knee Injury and Osteoarthritis Outcome Score Sports and Recreation Week-14	42.8 score on a scale Interval 30.6 to 55.1	45.3 score on a scale Interval 36.5 to 54.1
Knee Injury and Osteoarthritis Outcome Score Quality Of Life Baseline	45.8 score on a scale Interval 41.6 to 50.0	41.1 score on a scale Interval 35.1 to 47.1
Knee Injury and Osteoarthritis Outcome Score Quality Of Life Week-8	49 score on a scale Interval 44.1 to 53.8	48.5 score on a scale Interval 42.4 to 54.6

SECONDARY outcome

Timeframe: baseline, 8-week, 14-week

Population: On the 19 participants randomized to TX group, 18 provided data for this outcome at week 8 and week 14. Of the 21 participants assigned to the TMX group, 17 provided data for this outcome at week 8 and week 14.

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.

Outcome measures

Outcome measures
Measure	Group TX (Telehealth Exercise) n=19 Participants Participants in this group will receive a supervised and group-based exercise program once a week for 8 weeks via telehealth. Exercise: 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.	Group TMX (Telehealth Exercise and Mindfulness) n=21 Participants Participants in this group will receive a supervised, group-based integrated mindfulness and exercise program once a week for 8 weeks via telehealth. Mindful Exercise program: 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.
Pain, Enjoyment, General Activity Scale Baseline	4.9 score on a scale Interval 4.2 to 5.6	5.4 score on a scale Interval 4.6 to 6.1
Pain, Enjoyment, General Activity Scale Week-8	4 score on a scale Interval 2.9 to 5.0	3.9 score on a scale Interval 3.0 to 4.7
Pain, Enjoyment, General Activity Scale Week-14	3.9 score on a scale Interval 2.9 to 4.9	3.4 score on a scale Interval 2.5 to 4.4

SECONDARY outcome

Timeframe: baseline, 8-week, 14-week

Population: On the 19 participants randomized to TX group, 18 provided data for this outcome at week 8 and week 14. Of the 21 participants assigned to the TMX group, 17 provided data for this outcome at week 8 and week 14.

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

Outcome measures

Outcome measures
Measure	Group TX (Telehealth Exercise) n=19 Participants Participants in this group will receive a supervised and group-based exercise program once a week for 8 weeks via telehealth. Exercise: 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.	Group TMX (Telehealth Exercise and Mindfulness) n=21 Participants Participants in this group will receive a supervised, group-based integrated mindfulness and exercise program once a week for 8 weeks via telehealth. Mindful Exercise program: 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.
Numeric Rating Scale - Nominated Activity Baseline	6.1 score on a scale Interval 5.3 to 6.9	6.5 score on a scale Interval 6.1 to 6.9
Numeric Rating Scale - Nominated Activity Week-8	5.1 score on a scale Interval 4.0 to 6.2	5.2 score on a scale Interval 4.4 to 5.9
Numeric Rating Scale - Nominated Activity Week-14	4.8 score on a scale Interval 3.8 to 5.9	4.8 score on a scale Interval 3.8 to 5.7

SECONDARY outcome

Timeframe: 8-week, 14-week

Population: On the 19 participants randomized to TX group, 18 provided data for this outcome at week 8 and week 14. Of the 21 participants assigned to the TMX group, 16 provided data for this outcome at week 8 and 17 provided data for this outcome at week 14.

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.

Outcome measures

Outcome measures
Measure	Group TX (Telehealth Exercise) n=18 Participants Participants in this group will receive a supervised and group-based exercise program once a week for 8 weeks via telehealth. Exercise: 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.	Group TMX (Telehealth Exercise and Mindfulness) n=17 Participants Participants in this group will receive a supervised, group-based integrated mindfulness and exercise program once a week for 8 weeks via telehealth. Mindful Exercise program: 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.
Participant Global Impression of Change Week-8	2.2 score on a scale Interval 1.0 to 3.4	2.4 score on a scale Interval 1.2 to 3.7
Participant Global Impression of Change Week-14	1.4 score on a scale Interval 0.1 to 2.7	2.2 score on a scale Interval 1.1 to 3.3

SECONDARY outcome

Timeframe: baseline, 8-week, 14-week

Population: One participant in TX group and four participants in TMX Group were lost to follow-up

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

Outcome measures

Outcome measures
Measure	Group TX (Telehealth Exercise) n=19 Participants Participants in this group will receive a supervised and group-based exercise program once a week for 8 weeks via telehealth. Exercise: 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.	Group TMX (Telehealth Exercise and Mindfulness) n=21 Participants Participants in this group will receive a supervised, group-based integrated mindfulness and exercise program once a week for 8 weeks via telehealth. Mindful Exercise program: 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.
Patient Global Assessment of Osteoarthritis Baseline	59.8 score on a scale Interval 49.2 to 70.4	63.7 score on a scale Interval 54.7 to 72.6
Patient Global Assessment of Osteoarthritis Week-8	64.5 score on a scale Interval 54.5 to 74.5	65.7 score on a scale Interval 56.9 to 74.5
Patient Global Assessment of Osteoarthritis Week-14	60.2 score on a scale Interval 50.8 to 69.5	68.7 score on a scale Interval 60.7 to 76.7

SECONDARY outcome

Timeframe: baseline, 8-week

Population: On the 19 participants randomized to TX group, 18 provided data for this outcome at week 8. Of the 21 participants assigned to the TMX group, 17 provided data for this outcome at week 8.

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).

Outcome measures

Outcome measures
Measure	Group TX (Telehealth Exercise) n=19 Participants Participants in this group will receive a supervised and group-based exercise program once a week for 8 weeks via telehealth. Exercise: 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.	Group TMX (Telehealth Exercise and Mindfulness) n=21 Participants Participants in this group will receive a supervised, group-based integrated mindfulness and exercise program once a week for 8 weeks via telehealth. Mindful Exercise program: 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.
Pain Catastrophizing Scale Baseline	3.5 score on a scale Interval 2.7 to 4.4	3.9 score on a scale Interval 2.9 to 4.9
Pain Catastrophizing Scale Week-8	3.4 score on a scale Interval 2.3 to 4.6	3.1 score on a scale Interval 2.0 to 4.1

SECONDARY outcome

Timeframe: baseline, 8-week

Population: On the 19 participants randomized to TX group, 18 provided data for this outcome at week 8. Of the 21 participants assigned to the TMX group, 17 provided data for this outcome at week 8.

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.

Outcome measures

Outcome measures
Measure	Group TX (Telehealth Exercise) n=18 Participants Participants in this group will receive a supervised and group-based exercise program once a week for 8 weeks via telehealth. Exercise: 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.	Group TMX (Telehealth Exercise and Mindfulness) n=21 Participants Participants in this group will receive a supervised, group-based integrated mindfulness and exercise program once a week for 8 weeks via telehealth. Mindful Exercise program: 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.
Widespread Pain Index Symptom Severity Scale Baseline	3.9 score on a scale Interval 3.0 to 4.8	3.1 score on a scale Interval 2.2 to 4.1
Widespread Pain Index Symptom Severity Scale Week-8	4.1 score on a scale Interval 2.9 to 5.3	3.7 score on a scale Interval 2.6 to 4.9

SECONDARY outcome

Timeframe: baseline, 8-week

Population: On the 19 participants randomized to TX group, 18 provided data for this outcome at week 8. Of the 21 participants assigned to the TMX group, 20 provided data at baseline and 16 provided data for this outcome at week 8.

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

Outcome measures

Outcome measures
Measure	Group TX (Telehealth Exercise) n=18 Participants Participants in this group will receive a supervised and group-based exercise program once a week for 8 weeks via telehealth. Exercise: 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.	Group TMX (Telehealth Exercise and Mindfulness) n=20 Participants Participants in this group will receive a supervised, group-based integrated mindfulness and exercise program once a week for 8 weeks via telehealth. Mindful Exercise program: 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.
Pain DETECT Baseline	9.8 score on a scale Interval 7.1 to 12.4	8.5 score on a scale Interval 6.6 to 10.4
Pain DETECT Week-8	9.4 score on a scale Interval 7.0 to 11.8	7.6 score on a scale Interval 4.9 to 10.4

SECONDARY outcome

Timeframe: baseline, 8-week, 14-week

Population: On the 19 participants randomized to TX group, 18 provided data for this outcome at week 14. Of the 21 participants assigned to the TMX group, 17 provided data for this outcome at week 8 and week 14.

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

Outcome measures

Outcome measures
Measure	Group TX (Telehealth Exercise) n=19 Participants Participants in this group will receive a supervised and group-based exercise program once a week for 8 weeks via telehealth. Exercise: 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.	Group TMX (Telehealth Exercise and Mindfulness) n=21 Participants Participants in this group will receive a supervised, group-based integrated mindfulness and exercise program once a week for 8 weeks via telehealth. Mindful Exercise program: 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.
Patient Health Questionnaire 8-item Baseline	4.6 score on a scale Interval 2.3 to 6.9	3 score on a scale Interval 1.7 to 4.3
Patient Health Questionnaire 8-item Week-8	3.7 score on a scale Interval 2.2 to 5.3	3.9 score on a scale Interval 1.9 to 6.0
Patient Health Questionnaire 8-item Week-14	3.9 score on a scale Interval 2.4 to 5.5	4.1 score on a scale Interval 1.9 to 6.3

SECONDARY outcome

Timeframe: baseline, 8-week, 14-week

Population: On the 19 participants randomized to TX group, 18 provided data for this outcome at week 8 and 17 provided data at week 14. Of the 21 participants assigned to the TMX group, 17 provided data for this outcome at week 8 and week 14.

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.

Outcome measures

Outcome measures
Measure	Group TX (Telehealth Exercise) n=19 Participants Participants in this group will receive a supervised and group-based exercise program once a week for 8 weeks via telehealth. Exercise: 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.	Group TMX (Telehealth Exercise and Mindfulness) n=21 Participants Participants in this group will receive a supervised, group-based integrated mindfulness and exercise program once a week for 8 weeks via telehealth. Mindful Exercise program: 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.
Cognitive and Affective Mindfulness Scale - Revised Baseline	35.3 score on a scale Interval 32.7 to 37.8	37.4 score on a scale Interval 34.5 to 40.3
Cognitive and Affective Mindfulness Scale - Revised Week-8	33.9 score on a scale Interval 30.6 to 37.3	36.4 score on a scale Interval 33.0 to 39.9
Cognitive and Affective Mindfulness Scale - Revised Week-14	35.2 score on a scale Interval 32.1 to 38.4	37.3 score on a scale Interval 33.4 to 41.2

SECONDARY outcome

Timeframe: baseline, 8-week

Population: On the 19 participants randomized to TX group, 18 provided data for this outcome at week 8. Of the 21 participants assigned to the TMX group, 17 provided data for this outcome at week 8.

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

Outcome measures

Outcome measures
Measure	Group TX (Telehealth Exercise) n=19 Participants Participants in this group will receive a supervised and group-based exercise program once a week for 8 weeks via telehealth. Exercise: 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.	Group TMX (Telehealth Exercise and Mindfulness) n=21 Participants Participants in this group will receive a supervised, group-based integrated mindfulness and exercise program once a week for 8 weeks via telehealth. Mindful Exercise program: 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.
Fear Avoidance Beliefs Questionnaire - Physical Activity Baseline	18.3 score on a scale Interval 16.1 to 20.5	15.5 score on a scale Interval 12.9 to 18.1
Fear Avoidance Beliefs Questionnaire - Physical Activity Week-8	16.7 score on a scale Interval 13.4 to 20.0	14.8 score on a scale Interval 11.6 to 18.1

SECONDARY outcome

Timeframe: baseline, 8-week

Population: Of the 21 participants assigned to the TMX group, 16 provided data for this outcome at week 8.

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.

Outcome measures

Outcome measures
Measure	Group TX (Telehealth Exercise) n=19 Participants Participants in this group will receive a supervised and group-based exercise program once a week for 8 weeks via telehealth. Exercise: 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.	Group TMX (Telehealth Exercise and Mindfulness) n=21 Participants Participants in this group will receive a supervised, group-based integrated mindfulness and exercise program once a week for 8 weeks via telehealth. Mindful Exercise program: 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.
Arthritis Self Efficacy Scale Pain Baseline	6.5 score on a scale Interval 5.8 to 7.3	6.1 score on a scale Interval 5.6 to 6.6
Arthritis Self Efficacy Scale Pain Week-8	7.1 score on a scale Interval 6.3 to 7.9	6.2 score on a scale Interval 5.3 to 7.1
Arthritis Self Efficacy Scale Function Baseline	8 score on a scale Interval 7.4 to 8.7	7.7 score on a scale Interval 7.1 to 8.2
Arthritis Self Efficacy Scale Function Week-8	8.1 score on a scale Interval 7.2 to 9.1	8 score on a scale Interval 7.2 to 8.8
Arthritis Self Efficacy Scale Other symptoms Baseline	7 score on a scale Interval 6.2 to 7.7	6.8 score on a scale Interval 6.2 to 7.3
Arthritis Self Efficacy Scale Other symptoms Week-8	7.1 score on a scale Interval 6.3 to 7.9	7.2 score on a scale Interval 6.4 to 8.1

SECONDARY outcome

Timeframe: baseline, 8-week

Population: On the 19 participants randomized to TX group, 17 provided data for this outcome at week 8. Of the 21 participants assigned to the TMX group, 16 provided data for this outcome at week 8.

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.

Outcome measures

Outcome measures
Measure	Group TX (Telehealth Exercise) n=19 Participants Participants in this group will receive a supervised and group-based exercise program once a week for 8 weeks via telehealth. Exercise: 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.	Group TMX (Telehealth Exercise and Mindfulness) n=21 Participants Participants in this group will receive a supervised, group-based integrated mindfulness and exercise program once a week for 8 weeks via telehealth. Mindful Exercise program: 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.
Chronic Pain Self-efficacy Questionnaire Pain Baseline	71.5 score on a scale Interval 64.6 to 78.4	66.2 score on a scale Interval 59.6 to 72.7
Chronic Pain Self-efficacy Questionnaire Pain Week-8	66.8 score on a scale Interval 56.8 to 76.8	66.9 score on a scale Interval 59.1 to 74.8
Chronic Pain Self-efficacy Questionnaire Function Baseline	86 score on a scale Interval 78.8 to 93.2	81.4 score on a scale Interval 74.7 to 88.1
Chronic Pain Self-efficacy Questionnaire Function Week-8	82.2 score on a scale Interval 72.3 to 92.2	78.2 score on a scale Interval 66.5 to 89.9
Chronic Pain Self-efficacy Questionnaire Coping Baseline	68.1 score on a scale Interval 60.1 to 76.0	72.6 score on a scale Interval 66.3 to 78.8
Chronic Pain Self-efficacy Questionnaire Coping Week-8	71.2 score on a scale Interval 62.1 to 80.3	70.5 score on a scale Interval 60.6 to 80.5

Adverse Events

Group TX (Telehealth Exercise)

Serious events: 0 serious events

Other events: 8 other events

Deaths: 0 deaths

Group TMX (Telehealth Exercise and Mindfulness)

Serious events: 0 serious events

Other events: 3 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Group TX (Telehealth Exercise) n=19 participants at risk Participants in this group will receive a supervised and group-based exercise program once a week for 8 weeks via telehealth. Exercise: 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.	Group TMX (Telehealth Exercise and Mindfulness) n=21 participants at risk Participants in this group will receive a supervised, group-based integrated mindfulness and exercise program once a week for 8 weeks via telehealth. Mindful Exercise program: 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.
Musculoskeletal and connective tissue disorders Exacerbation of knee pain	21.1% 4/19 • 14-weeks The adverse events were self-reported by participants during the course of the study. No serious adverse events were reported by participants in either groups.	0.00% 0/21 • 14-weeks The adverse events were self-reported by participants during the course of the study. No serious adverse events were reported by participants in either groups.
Surgical and medical procedures Hernia surgery	0.00% 0/19 • 14-weeks The adverse events were self-reported by participants during the course of the study. No serious adverse events were reported by participants in either groups.	4.8% 1/21 • 14-weeks The adverse events were self-reported by participants during the course of the study. No serious adverse events were reported by participants in either groups.
Infections and infestations Flu	10.5% 2/19 • 14-weeks The adverse events were self-reported by participants during the course of the study. No serious adverse events were reported by participants in either groups.	4.8% 1/21 • 14-weeks The adverse events were self-reported by participants during the course of the study. No serious adverse events were reported by participants in either groups.
Musculoskeletal and connective tissue disorders Ankle injury	0.00% 0/19 • 14-weeks The adverse events were self-reported by participants during the course of the study. No serious adverse events were reported by participants in either groups.	4.8% 1/21 • 14-weeks The adverse events were self-reported by participants during the course of the study. No serious adverse events were reported by participants in either groups.
Surgical and medical procedures Knee replacement surgery	5.3% 1/19 • 14-weeks The adverse events were self-reported by participants during the course of the study. No serious adverse events were reported by participants in either groups.	0.00% 0/21 • 14-weeks The adverse events were self-reported by participants during the course of the study. No serious adverse events were reported by participants in either groups.
General disorders Generally feeling unwell	5.3% 1/19 • 14-weeks The adverse events were self-reported by participants during the course of the study. No serious adverse events were reported by participants in either groups.	0.00% 0/21 • 14-weeks The adverse events were self-reported by participants during the course of the study. No serious adverse events were reported by participants in either groups.

Additional Information

Dr. Deepak Kumar

Boston University

Phone: 3026901455

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place