Trial Outcomes & Findings for University of Wisconsin Meditation & Exercise Cold Study (NCT NCT01654289)
NCT ID: NCT01654289
Last Updated: 2018-11-07
Results Overview
The primary outcome will be severity-weighted total cumulative days of ARI illness (global severity), calculated as trapezoidal approximation to area under the time severity curve during ARI illness, with severity assessed once daily using self-reports on the validated Wisconsin Upper Respiratory Symptom Survey (WURSS-24). Incidence (number of ARI episodes in each group) and duration (total number of days of ARI illness) are components of the primary outcome, and will be analyzed separately.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
413 participants
Primary outcome timeframe
8 months
Results posted on
2018-11-07
Participant Flow
Participants recruited from the greater Madison WI (USA) community between July 2012 and September 2016.
Prospective subjects were met in person for informed consent and enrollment in a 2-week run-in trial. Run-in tasks included baseline questionnaires, at least one phone contact, self-report questionnaires at home, and a follow-up in-person appointment. Successful completion of run-in activities allowed participants to enroll in main study.
Participant milestones
| Measure |
Mindfulness Meditation
Training will consist of a standardized 8-week Mindfulness Based Stress Reduction (MBSR) program, including 2½ hour weekly sessions and approximately 45 minutes per day at-home daily practice.
Mindfulness Meditation: Training will consist of a standardized 8-week Mindfulness Based Stress Reduction (MBSR) program, including 2½ hour weekly sessions and regular at-home daily practice. Didactic sessions center on awareness of physical, emotional, cognitive, and interpersonal responses to stress. A half day meditation "retreat" on a weekend day at the end of week 6 will allow participants to practice their skills.
|
Exercise
The exercise intervention structure is consistent with many standardized exercise programs. The exercise program will match the meditation program in duration (8 weeks), attention (weekly 2½ hour group sessions), and intensity (daily 45 minute at-home practice).
Exercise: Exercise training will primarily focus on walking or jogging, activities that are convenient, easy to teach and do not require special equipment. Individualized programs will be developed for those who have access to specific equipment, are unable to do walking/jogging, or prefer different types of exercise. Each weekly exercise session will include 1½ hours of didactic and 1 hour of group exercise. A half day exercise retreat designed to match the meditation retreat will occur the weekend of week 6. The retreat will include didactics, group discussion and activities, and individualized exercise practice.
|
Wait-list Control
Apart from not attending any of the specific meditation or exercise training sessions, those in the control group will be treated in essentially the same manner as "experimental" participants.
|
|---|---|---|---|
|
Overall Study
STARTED
|
138
|
137
|
138
|
|
Overall Study
COMPLETED
|
111
|
109
|
133
|
|
Overall Study
NOT COMPLETED
|
27
|
28
|
5
|
Reasons for withdrawal
| Measure |
Mindfulness Meditation
Training will consist of a standardized 8-week Mindfulness Based Stress Reduction (MBSR) program, including 2½ hour weekly sessions and approximately 45 minutes per day at-home daily practice.
Mindfulness Meditation: Training will consist of a standardized 8-week Mindfulness Based Stress Reduction (MBSR) program, including 2½ hour weekly sessions and regular at-home daily practice. Didactic sessions center on awareness of physical, emotional, cognitive, and interpersonal responses to stress. A half day meditation "retreat" on a weekend day at the end of week 6 will allow participants to practice their skills.
|
Exercise
The exercise intervention structure is consistent with many standardized exercise programs. The exercise program will match the meditation program in duration (8 weeks), attention (weekly 2½ hour group sessions), and intensity (daily 45 minute at-home practice).
Exercise: Exercise training will primarily focus on walking or jogging, activities that are convenient, easy to teach and do not require special equipment. Individualized programs will be developed for those who have access to specific equipment, are unable to do walking/jogging, or prefer different types of exercise. Each weekly exercise session will include 1½ hours of didactic and 1 hour of group exercise. A half day exercise retreat designed to match the meditation retreat will occur the weekend of week 6. The retreat will include didactics, group discussion and activities, and individualized exercise practice.
|
Wait-list Control
Apart from not attending any of the specific meditation or exercise training sessions, those in the control group will be treated in essentially the same manner as "experimental" participants.
|
|---|---|---|---|
|
Overall Study
Withdrawal by Subject
|
10
|
8
|
5
|
|
Overall Study
Withdrew from intervention only
|
17
|
20
|
0
|
Baseline Characteristics
University of Wisconsin Meditation & Exercise Cold Study
Baseline characteristics by cohort
| Measure |
Mindfulness Meditation
n=138 Participants
Training will consist of a standardized 8-week Mindfulness Based Stress Reduction (MBSR) program, including 2½ hour weekly sessions and approximately 45 minutes per day at-home daily practice.
Mindfulness Meditation: Training will consist of a standardized 8-week Mindfulness Based Stress Reduction (MBSR) program, including 2½ hour weekly sessions and regular at-home daily practice. Didactic sessions center on awareness of physical, emotional, cognitive, and interpersonal responses to stress. A half day meditation "retreat" on a weekend day at the end of week 6 will allow participants to practice their skills.
|
Exercise
n=137 Participants
The exercise intervention structure is consistent with many standardized exercise programs. The exercise program will match the meditation program in duration (8 weeks), attention (weekly 2½ hour group sessions), and intensity (daily 45 minute at-home practice).
Exercise: Exercise training will primarily focus on walking or jogging, activities that are convenient, easy to teach and do not require special equipment. Individualized programs will be developed for those who have access to specific equipment, are unable to do walking/jogging, or prefer different types of exercise. Each weekly exercise session will include 1½ hours of didactic and 1 hour of group exercise. A half day exercise retreat designed to match the meditation retreat will occur the weekend of week 6. The retreat will include didactics, group discussion and activities, and individualized exercise practice.
|
Wait-list Control
n=138 Participants
Apart from not attending any of the specific meditation or exercise training sessions, those in the control group will be treated in essentially the same manner as "experimental" participants.
|
Total
n=413 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
49.1 years
STANDARD_DEVIATION 11.4 • n=5 Participants
|
49.2 years
STANDARD_DEVIATION 11.2 • n=7 Participants
|
50.7 years
STANDARD_DEVIATION 12.1 • n=5 Participants
|
49.7 years
STANDARD_DEVIATION 11.6 • n=4 Participants
|
|
Sex: Female, Male
Female
|
105 Participants
n=5 Participants
|
107 Participants
n=7 Participants
|
101 Participants
n=5 Participants
|
313 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
33 Participants
n=5 Participants
|
30 Participants
n=7 Participants
|
37 Participants
n=5 Participants
|
100 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
11 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
24 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
127 Participants
n=5 Participants
|
132 Participants
n=7 Participants
|
130 Participants
n=5 Participants
|
389 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Asian
|
5 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
16 Participants
n=4 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
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Black or African American
|
5 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
25 Participants
n=4 Participants
|
|
Race (NIH/OMB)
White
|
121 Participants
n=5 Participants
|
105 Participants
n=7 Participants
|
123 Participants
n=5 Participants
|
349 Participants
n=4 Participants
|
|
Race (NIH/OMB)
More than one race
|
7 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
23 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Region of Enrollment
United States
|
138 participants
n=5 Participants
|
137 participants
n=7 Participants
|
138 participants
n=5 Participants
|
413 participants
n=4 Participants
|
PRIMARY outcome
Timeframe: 8 monthsThe primary outcome will be severity-weighted total cumulative days of ARI illness (global severity), calculated as trapezoidal approximation to area under the time severity curve during ARI illness, with severity assessed once daily using self-reports on the validated Wisconsin Upper Respiratory Symptom Survey (WURSS-24). Incidence (number of ARI episodes in each group) and duration (total number of days of ARI illness) are components of the primary outcome, and will be analyzed separately.
Outcome measures
| Measure |
Mindfulness Meditation
n=138 Participants
Training will consist of a standardized 8-week Mindfulness Based Stress Reduction (MBSR) program, including 2½ hour weekly sessions and approximately 45 minutes per day at-home daily practice.
Mindfulness Meditation: Training will consist of a standardized 8-week Mindfulness Based Stress Reduction (MBSR) program, including 2½ hour weekly sessions and regular at-home daily practice. Didactic sessions center on awareness of physical, emotional, cognitive, and interpersonal responses to stress. A half day meditation "retreat" on a weekend day at the end of week 6 will allow participants to practice their skills.
|
Exercise
n=137 Participants
The exercise intervention structure is consistent with many standardized exercise programs. The exercise program will match the meditation program in duration (8 weeks), attention (weekly 2½ hour group sessions), and intensity (daily 45 minute at-home practice).
Exercise: Exercise training will primarily focus on walking or jogging, activities that are convenient, easy to teach and do not require special equipment. Individualized programs will be developed for those who have access to specific equipment, are unable to do walking/jogging, or prefer different types of exercise. Each weekly exercise session will include 1½ hours of didactic and 1 hour of group exercise. A half day exercise retreat designed to match the meditation retreat will occur the weekend of week 6. The retreat will include didactics, group discussion and activities, and individualized exercise practice.
|
Wait-list Control
n=138 Participants
Apart from not attending any of the specific meditation or exercise training sessions, those in the control group will be treated in essentially the same manner as "experimental" participants.
|
|---|---|---|---|
|
Severity-weighted Total Days of ARI Illness
|
1045 severity*days
|
1010 severity*days
|
1210 severity*days
|
SECONDARY outcome
Timeframe: 8 monthsEmployment, including type of work, hours per week worked, and compensation, assessed as hourly wage, will be assessed at enrollment. Each week throughout the study participants will complete questions to assess number of hours of work missed. Study personnel blinded to allocation group status will assess and classify reasons for missed work as either ARI-related or not ARI-related. Presented as a total cumulative number of days missed of work due to an ARI-related event.
Outcome measures
| Measure |
Mindfulness Meditation
n=138 Participants
Training will consist of a standardized 8-week Mindfulness Based Stress Reduction (MBSR) program, including 2½ hour weekly sessions and approximately 45 minutes per day at-home daily practice.
Mindfulness Meditation: Training will consist of a standardized 8-week Mindfulness Based Stress Reduction (MBSR) program, including 2½ hour weekly sessions and regular at-home daily practice. Didactic sessions center on awareness of physical, emotional, cognitive, and interpersonal responses to stress. A half day meditation "retreat" on a weekend day at the end of week 6 will allow participants to practice their skills.
|
Exercise
n=137 Participants
The exercise intervention structure is consistent with many standardized exercise programs. The exercise program will match the meditation program in duration (8 weeks), attention (weekly 2½ hour group sessions), and intensity (daily 45 minute at-home practice).
Exercise: Exercise training will primarily focus on walking or jogging, activities that are convenient, easy to teach and do not require special equipment. Individualized programs will be developed for those who have access to specific equipment, are unable to do walking/jogging, or prefer different types of exercise. Each weekly exercise session will include 1½ hours of didactic and 1 hour of group exercise. A half day exercise retreat designed to match the meditation retreat will occur the weekend of week 6. The retreat will include didactics, group discussion and activities, and individualized exercise practice.
|
Wait-list Control
n=138 Participants
Apart from not attending any of the specific meditation or exercise training sessions, those in the control group will be treated in essentially the same manner as "experimental" participants.
|
|---|---|---|---|
|
Absenteeism
|
73 Total # of ARI-related Missed Work days
|
81 Total # of ARI-related Missed Work days
|
105 Total # of ARI-related Missed Work days
|
SECONDARY outcome
Timeframe: 8 monthsCumulative total number of health care visits, ARI-related health care visits, and ARI-related prescriptions, including antibiotics and anti-influenza anti-virals will be documented. Each weekly communication will include the question, "Have you seen a doctor or visited a clinic, hospital or urgent care center?" Persons answering "Yes" will be asked the reason for the visit. Those answers will then be classified by blinded study personnel as either "Related," or "Unrelated" to ARI illness, including upper respiratory infection, influenza, pharyngitis, acute sinusitis, bronchitis, and pneumonia.
Outcome measures
| Measure |
Mindfulness Meditation
n=138 Participants
Training will consist of a standardized 8-week Mindfulness Based Stress Reduction (MBSR) program, including 2½ hour weekly sessions and approximately 45 minutes per day at-home daily practice.
Mindfulness Meditation: Training will consist of a standardized 8-week Mindfulness Based Stress Reduction (MBSR) program, including 2½ hour weekly sessions and regular at-home daily practice. Didactic sessions center on awareness of physical, emotional, cognitive, and interpersonal responses to stress. A half day meditation "retreat" on a weekend day at the end of week 6 will allow participants to practice their skills.
|
Exercise
n=137 Participants
The exercise intervention structure is consistent with many standardized exercise programs. The exercise program will match the meditation program in duration (8 weeks), attention (weekly 2½ hour group sessions), and intensity (daily 45 minute at-home practice).
Exercise: Exercise training will primarily focus on walking or jogging, activities that are convenient, easy to teach and do not require special equipment. Individualized programs will be developed for those who have access to specific equipment, are unable to do walking/jogging, or prefer different types of exercise. Each weekly exercise session will include 1½ hours of didactic and 1 hour of group exercise. A half day exercise retreat designed to match the meditation retreat will occur the weekend of week 6. The retreat will include didactics, group discussion and activities, and individualized exercise practice.
|
Wait-list Control
n=138 Participants
Apart from not attending any of the specific meditation or exercise training sessions, those in the control group will be treated in essentially the same manner as "experimental" participants.
|
|---|---|---|---|
|
Health Care Utilization
|
22 Total # ARI-related Medical visits
|
21 Total # ARI-related Medical visits
|
24 Total # ARI-related Medical visits
|
SECONDARY outcome
Timeframe: Baseline and 8 months (exit from study)Population: Obtained participant data reported.
Also known as the Medical Outcomes Study Short Form, this 12-item questionnaire is commonly used to measure overall health, including physical (SF12-P) and mental health (SF12-M) subscales. It has been extensively assessed for reliability, responsiveness and criterion validity. In this study, it will be used to assess potential changes in general physical and mental health due to interventions, and as a covariate to control for baseline between-person differences in multivariate efficacy analyses. Physical and Mental Health Composite Scores are computed using the scores of twelve questions and range from 0 to 100, where a zero score indicates the lowest level of health measured by the scales and 100 indicates the highest level of health.
Outcome measures
| Measure |
Mindfulness Meditation
n=138 Participants
Training will consist of a standardized 8-week Mindfulness Based Stress Reduction (MBSR) program, including 2½ hour weekly sessions and approximately 45 minutes per day at-home daily practice.
Mindfulness Meditation: Training will consist of a standardized 8-week Mindfulness Based Stress Reduction (MBSR) program, including 2½ hour weekly sessions and regular at-home daily practice. Didactic sessions center on awareness of physical, emotional, cognitive, and interpersonal responses to stress. A half day meditation "retreat" on a weekend day at the end of week 6 will allow participants to practice their skills.
|
Exercise
n=137 Participants
The exercise intervention structure is consistent with many standardized exercise programs. The exercise program will match the meditation program in duration (8 weeks), attention (weekly 2½ hour group sessions), and intensity (daily 45 minute at-home practice).
Exercise: Exercise training will primarily focus on walking or jogging, activities that are convenient, easy to teach and do not require special equipment. Individualized programs will be developed for those who have access to specific equipment, are unable to do walking/jogging, or prefer different types of exercise. Each weekly exercise session will include 1½ hours of didactic and 1 hour of group exercise. A half day exercise retreat designed to match the meditation retreat will occur the weekend of week 6. The retreat will include didactics, group discussion and activities, and individualized exercise practice.
|
Wait-list Control
n=138 Participants
Apart from not attending any of the specific meditation or exercise training sessions, those in the control group will be treated in essentially the same manner as "experimental" participants.
|
|---|---|---|---|
|
SF-12
SF12-P Baseline
|
51.2 score on a scale
Interval 35.6 to 67.1
|
51.4 score on a scale
Interval 34.9 to 67.8
|
51.4 score on a scale
Interval 35.1 to 67.6
|
|
SF-12
SF-12-P Exit
|
50.5 score on a scale
Interval 31.4 to 71.7
|
51.9 score on a scale
Interval 32.2 to 70.9
|
51.5 score on a scale
Interval 33.9 to 69.2
|
|
SF-12
SF12-M Baseline
|
48.0 score on a scale
Interval 28.0 to 67.1
|
47.9 score on a scale
Interval 27.1 to 68.0
|
47.6 score on a scale
Interval 28.2 to 66.9
|
|
SF-12
SF-12-M Exit
|
49.7 score on a scale
Interval 25.2 to 66.5
|
47.8 score on a scale
Interval 26.2 to 65.6
|
45.9 score on a scale
Interval 25.1 to 66.6
|
SECONDARY outcome
Timeframe: Baseline and 8 months (exit from study)Population: Obtained participant data reported.
The PSS-10 has been validated in multiple studies. PSS scores predict rates of viral infection among volunteers inoculated with rhinovirus, and correlate with physiologic and self-report indicators of ARI illness, including nasal IL-6 level. Because stress reduction is one of the hypothesized mechanisms of action, this study population will include working-age participants, who are presumed to be more stressed. Individual scores on the PSS can range from 0 to 40 with higher scores indicating higher perceived stress. * Scores ranging from 0-13 would be considered low stress. * Scores ranging from 14-26 would be considered moderate stress. * Scores ranging from 27-40 would be considered high perceived stress.
Outcome measures
| Measure |
Mindfulness Meditation
n=138 Participants
Training will consist of a standardized 8-week Mindfulness Based Stress Reduction (MBSR) program, including 2½ hour weekly sessions and approximately 45 minutes per day at-home daily practice.
Mindfulness Meditation: Training will consist of a standardized 8-week Mindfulness Based Stress Reduction (MBSR) program, including 2½ hour weekly sessions and regular at-home daily practice. Didactic sessions center on awareness of physical, emotional, cognitive, and interpersonal responses to stress. A half day meditation "retreat" on a weekend day at the end of week 6 will allow participants to practice their skills.
|
Exercise
n=137 Participants
The exercise intervention structure is consistent with many standardized exercise programs. The exercise program will match the meditation program in duration (8 weeks), attention (weekly 2½ hour group sessions), and intensity (daily 45 minute at-home practice).
Exercise: Exercise training will primarily focus on walking or jogging, activities that are convenient, easy to teach and do not require special equipment. Individualized programs will be developed for those who have access to specific equipment, are unable to do walking/jogging, or prefer different types of exercise. Each weekly exercise session will include 1½ hours of didactic and 1 hour of group exercise. A half day exercise retreat designed to match the meditation retreat will occur the weekend of week 6. The retreat will include didactics, group discussion and activities, and individualized exercise practice.
|
Wait-list Control
n=138 Participants
Apart from not attending any of the specific meditation or exercise training sessions, those in the control group will be treated in essentially the same manner as "experimental" participants.
|
|---|---|---|---|
|
Perceived Stress Scale (PSS-10)
PSS-10 Baseline
|
13.1 score on a scale
Interval -0.3 to 25.0
|
13.3 score on a scale
Interval -0.5 to 25.3
|
12.4 score on a scale
Interval 0.8 to 24.0
|
|
Perceived Stress Scale (PSS-10)
PSS-10 Exit
|
11.6 score on a scale
Interval 0.8 to 26.0
|
13.3 score on a scale
Interval -0.5 to 27.4
|
13.4 score on a scale
Interval 0.6 to 26.2
|
SECONDARY outcome
Timeframe: 8 months (exit from study)The MSES is one of the more recent questionnaires, developed by Cayoun and Freestun to assess effects of MBSR training on perceived self-efficacy. The MSES assesses 7 domains related to mindfulness self-efficacy, including behavior, cognition, interoception, affect, interpersonal, avoidance and mindfulness. The MSES will provide a nice counterpart to the ESES to help distinguish effects of interventions on ARI outcomes. The lower the score, the lower self-efficacy is in using mindfulness skills. The current lack of psychometric data for the MSES renders the following ranges very tentative. They are currently only a rough clinical guide and scores must be interpreted with caution. 0-34 Poor sense of self-efficacy 35-69 Weak sense of self-efficacy 70-104 Moderate sense of self-efficacy 105-140 Good sense of self-efficacy
Outcome measures
| Measure |
Mindfulness Meditation
n=138 Participants
Training will consist of a standardized 8-week Mindfulness Based Stress Reduction (MBSR) program, including 2½ hour weekly sessions and approximately 45 minutes per day at-home daily practice.
Mindfulness Meditation: Training will consist of a standardized 8-week Mindfulness Based Stress Reduction (MBSR) program, including 2½ hour weekly sessions and regular at-home daily practice. Didactic sessions center on awareness of physical, emotional, cognitive, and interpersonal responses to stress. A half day meditation "retreat" on a weekend day at the end of week 6 will allow participants to practice their skills.
|
Exercise
n=137 Participants
The exercise intervention structure is consistent with many standardized exercise programs. The exercise program will match the meditation program in duration (8 weeks), attention (weekly 2½ hour group sessions), and intensity (daily 45 minute at-home practice).
Exercise: Exercise training will primarily focus on walking or jogging, activities that are convenient, easy to teach and do not require special equipment. Individualized programs will be developed for those who have access to specific equipment, are unable to do walking/jogging, or prefer different types of exercise. Each weekly exercise session will include 1½ hours of didactic and 1 hour of group exercise. A half day exercise retreat designed to match the meditation retreat will occur the weekend of week 6. The retreat will include didactics, group discussion and activities, and individualized exercise practice.
|
Wait-list Control
n=138 Participants
Apart from not attending any of the specific meditation or exercise training sessions, those in the control group will be treated in essentially the same manner as "experimental" participants.
|
|---|---|---|---|
|
Mindfulness-based Self Efficacy Scale (MSES)
|
97.6 score on a scale
Standard Deviation 15.7
|
97.3 score on a scale
Standard Deviation 14.7
|
96.8 score on a scale
Standard Deviation 14.6
|
SECONDARY outcome
Timeframe: Baseline and 8 months (exit from study)Population: Obtained participant data reported.
Self-efficacy has been defined as "the belief in one's capabilities to organize and execute the courses of action required to manage prospective situations." The ESES scale was developed based on work by Bandura and colleagues,and has been validated by Shin, Kroll,and Everett. For this study, the ESES will be used to verify results of the exercise intervention, and to help explain potential mediational effects of exercise. The total score is derived by summing the scores for the individual items; possible scores range from 0 to 180. Total score (out of 180) is sum of item scores. Higher score represents greater perceived self efficacy.
Outcome measures
| Measure |
Mindfulness Meditation
n=138 Participants
Training will consist of a standardized 8-week Mindfulness Based Stress Reduction (MBSR) program, including 2½ hour weekly sessions and approximately 45 minutes per day at-home daily practice.
Mindfulness Meditation: Training will consist of a standardized 8-week Mindfulness Based Stress Reduction (MBSR) program, including 2½ hour weekly sessions and regular at-home daily practice. Didactic sessions center on awareness of physical, emotional, cognitive, and interpersonal responses to stress. A half day meditation "retreat" on a weekend day at the end of week 6 will allow participants to practice their skills.
|
Exercise
n=137 Participants
The exercise intervention structure is consistent with many standardized exercise programs. The exercise program will match the meditation program in duration (8 weeks), attention (weekly 2½ hour group sessions), and intensity (daily 45 minute at-home practice).
Exercise: Exercise training will primarily focus on walking or jogging, activities that are convenient, easy to teach and do not require special equipment. Individualized programs will be developed for those who have access to specific equipment, are unable to do walking/jogging, or prefer different types of exercise. Each weekly exercise session will include 1½ hours of didactic and 1 hour of group exercise. A half day exercise retreat designed to match the meditation retreat will occur the weekend of week 6. The retreat will include didactics, group discussion and activities, and individualized exercise practice.
|
Wait-list Control
n=138 Participants
Apart from not attending any of the specific meditation or exercise training sessions, those in the control group will be treated in essentially the same manner as "experimental" participants.
|
|---|---|---|---|
|
Exercise Self-Efficacy Scale (ESES)
ESES - Baseline
|
112.5 score on a scale
Interval 41.0 to 191.0
|
112.4 score on a scale
Interval 40.3 to 191.6
|
116.0 score on a scale
Interval 39.9 to 192.1
|
|
Exercise Self-Efficacy Scale (ESES)
ESES - Exit
|
94.3 score on a scale
Interval 8.9 to 160.2
|
104.4 score on a scale
Interval 13.4 to 155.8
|
84.6 score on a scale
Interval 13.3 to 155.9
|
SECONDARY outcome
Timeframe: Baseline and 8 months (exit from study)Population: Obtained participant data reported.
Sleep quality has been linked to several important quality of life and health outcomes. The PSQI is widely used and has been assessed for reliability and validity.In this study, improved sleep is a potential mediator of intervention effects, and a potentially important outcome on its own. The PSQI includes a scoring key for calculating a patient's seven subscores, each of which can range from 0 to 3. The subscores are tallied, yielding a "global" score that can range from 0 to 21. A global score of 5 or more indicates poor sleep quality; the higher the score, the worse the quality.
Outcome measures
| Measure |
Mindfulness Meditation
n=138 Participants
Training will consist of a standardized 8-week Mindfulness Based Stress Reduction (MBSR) program, including 2½ hour weekly sessions and approximately 45 minutes per day at-home daily practice.
Mindfulness Meditation: Training will consist of a standardized 8-week Mindfulness Based Stress Reduction (MBSR) program, including 2½ hour weekly sessions and regular at-home daily practice. Didactic sessions center on awareness of physical, emotional, cognitive, and interpersonal responses to stress. A half day meditation "retreat" on a weekend day at the end of week 6 will allow participants to practice their skills.
|
Exercise
n=137 Participants
The exercise intervention structure is consistent with many standardized exercise programs. The exercise program will match the meditation program in duration (8 weeks), attention (weekly 2½ hour group sessions), and intensity (daily 45 minute at-home practice).
Exercise: Exercise training will primarily focus on walking or jogging, activities that are convenient, easy to teach and do not require special equipment. Individualized programs will be developed for those who have access to specific equipment, are unable to do walking/jogging, or prefer different types of exercise. Each weekly exercise session will include 1½ hours of didactic and 1 hour of group exercise. A half day exercise retreat designed to match the meditation retreat will occur the weekend of week 6. The retreat will include didactics, group discussion and activities, and individualized exercise practice.
|
Wait-list Control
n=138 Participants
Apart from not attending any of the specific meditation or exercise training sessions, those in the control group will be treated in essentially the same manner as "experimental" participants.
|
|---|---|---|---|
|
Pittsburgh Sleep Quality Index (PSQI)
PSQI - EXIT
|
5.1 score on a scale
Interval -0.1 to 11.8
|
5.3 score on a scale
Interval -0.4 to 12.0
|
5.8 score on a scale
Interval -1.3 to 13.0
|
|
Pittsburgh Sleep Quality Index (PSQI)
PSQI - BASELINE
|
5.8 score on a scale
Interval -0.7 to 12.0
|
6.2 score on a scale
Interval -1.4 to 12.7
|
5.7 score on a scale
Interval -0.8 to 12.1
|
SECONDARY outcome
Timeframe: Baseline and 8 months (exit from study)Population: Obtained participant data reported.
Body habitus is associated with many disease processes, and may be related to immune function and susceptibility to respiratory infection. Height will be assessed at baseline only. Weight will be measured at baseline, 1 and 4 months post-intervention, and at exit. Baseline BMI will be calculated and used as a covariate in statistical models. BMI will also be considered a secondary outcome of potential importance.
Outcome measures
| Measure |
Mindfulness Meditation
n=138 Participants
Training will consist of a standardized 8-week Mindfulness Based Stress Reduction (MBSR) program, including 2½ hour weekly sessions and approximately 45 minutes per day at-home daily practice.
Mindfulness Meditation: Training will consist of a standardized 8-week Mindfulness Based Stress Reduction (MBSR) program, including 2½ hour weekly sessions and regular at-home daily practice. Didactic sessions center on awareness of physical, emotional, cognitive, and interpersonal responses to stress. A half day meditation "retreat" on a weekend day at the end of week 6 will allow participants to practice their skills.
|
Exercise
n=137 Participants
The exercise intervention structure is consistent with many standardized exercise programs. The exercise program will match the meditation program in duration (8 weeks), attention (weekly 2½ hour group sessions), and intensity (daily 45 minute at-home practice).
Exercise: Exercise training will primarily focus on walking or jogging, activities that are convenient, easy to teach and do not require special equipment. Individualized programs will be developed for those who have access to specific equipment, are unable to do walking/jogging, or prefer different types of exercise. Each weekly exercise session will include 1½ hours of didactic and 1 hour of group exercise. A half day exercise retreat designed to match the meditation retreat will occur the weekend of week 6. The retreat will include didactics, group discussion and activities, and individualized exercise practice.
|
Wait-list Control
n=138 Participants
Apart from not attending any of the specific meditation or exercise training sessions, those in the control group will be treated in essentially the same manner as "experimental" participants.
|
|---|---|---|---|
|
Body Mass Index (BMI)
BMI - BASELINE
|
29.8 kg/m2
Interval 13.7 to 44.4
|
29.3 kg/m2
Interval 15.4 to 42.7
|
29.0 kg/m2
Interval 16.0 to 42.0
|
|
Body Mass Index (BMI)
BMI - EXIT
|
28.2 kg/m2
Interval 24.2 to 33.4
|
27.4 kg/m2
Interval 24.3 to 32.0
|
27.9 kg/m2
Interval 24.1 to 33.0
|
SECONDARY outcome
Timeframe: Baseline and 8 months (exit from study)Population: Obtained participant data reported.
Standard brachial blood pressure will be assessed by trained nurses using calibrated sphygmomanometers.
Outcome measures
| Measure |
Mindfulness Meditation
n=138 Participants
Training will consist of a standardized 8-week Mindfulness Based Stress Reduction (MBSR) program, including 2½ hour weekly sessions and approximately 45 minutes per day at-home daily practice.
Mindfulness Meditation: Training will consist of a standardized 8-week Mindfulness Based Stress Reduction (MBSR) program, including 2½ hour weekly sessions and regular at-home daily practice. Didactic sessions center on awareness of physical, emotional, cognitive, and interpersonal responses to stress. A half day meditation "retreat" on a weekend day at the end of week 6 will allow participants to practice their skills.
|
Exercise
n=137 Participants
The exercise intervention structure is consistent with many standardized exercise programs. The exercise program will match the meditation program in duration (8 weeks), attention (weekly 2½ hour group sessions), and intensity (daily 45 minute at-home practice).
Exercise: Exercise training will primarily focus on walking or jogging, activities that are convenient, easy to teach and do not require special equipment. Individualized programs will be developed for those who have access to specific equipment, are unable to do walking/jogging, or prefer different types of exercise. Each weekly exercise session will include 1½ hours of didactic and 1 hour of group exercise. A half day exercise retreat designed to match the meditation retreat will occur the weekend of week 6. The retreat will include didactics, group discussion and activities, and individualized exercise practice.
|
Wait-list Control
n=138 Participants
Apart from not attending any of the specific meditation or exercise training sessions, those in the control group will be treated in essentially the same manner as "experimental" participants.
|
|---|---|---|---|
|
Blood Pressure
Systolic - Baseline
|
120.4 mm Hg
Interval 92.0 to 156.4
|
121.8 mm Hg
Interval 94.2 to 154.2
|
124.2 mm Hg
Interval 91.6 to 156.8
|
|
Blood Pressure
Diastolic-Baseline
|
74.3 mm Hg
Interval 59.4 to 92.3
|
75.0 mm Hg
Interval 58.3 to 93.4
|
75.8 mm Hg
Interval 57.7 to 94.0
|
|
Blood Pressure
Systolic - Exit
|
121.0 mm Hg
Interval 109.0 to 133.0
|
122.0 mm Hg
Interval 108.0 to 130.0
|
124.0 mm Hg
Interval 113.0 to 132.0
|
|
Blood Pressure
Diastolic - Exit
|
77.0 mm Hg
Interval 69.0 to 82.0
|
76.0 mm Hg
Interval 69.0 to 82.0
|
78.0 mm Hg
Interval 71.0 to 83.0
|
SECONDARY outcome
Timeframe: Baseline, 4 months post-intervention (December) and 8 months post-intervention (March).Population: Obtained participant data reported.
Laboratory-assessed objective measures will primarily serve to corroborate self-reports of disease severity. High sensitivity C-reactive protein (HS-CRP) is a well-established indicator of disease severity during respiratory infection, and can be measured in serum and in nasal wash.Concentrations of interleukin-6 (IL-6)and interleukin-8 (IL-8)in nasal wash have been shown to correlate with illness severity. More recently, interferon-gamma-induced protein 10 (IP-10) has been shown to be measurably increased in both serum and nasal wash during times of acute viral ARI. Biomarker levels were measured at the two standardized follow-up visits in December and March when participants were not ill.
Outcome measures
| Measure |
Mindfulness Meditation
n=138 Participants
Training will consist of a standardized 8-week Mindfulness Based Stress Reduction (MBSR) program, including 2½ hour weekly sessions and approximately 45 minutes per day at-home daily practice.
Mindfulness Meditation: Training will consist of a standardized 8-week Mindfulness Based Stress Reduction (MBSR) program, including 2½ hour weekly sessions and regular at-home daily practice. Didactic sessions center on awareness of physical, emotional, cognitive, and interpersonal responses to stress. A half day meditation "retreat" on a weekend day at the end of week 6 will allow participants to practice their skills.
|
Exercise
n=137 Participants
The exercise intervention structure is consistent with many standardized exercise programs. The exercise program will match the meditation program in duration (8 weeks), attention (weekly 2½ hour group sessions), and intensity (daily 45 minute at-home practice).
Exercise: Exercise training will primarily focus on walking or jogging, activities that are convenient, easy to teach and do not require special equipment. Individualized programs will be developed for those who have access to specific equipment, are unable to do walking/jogging, or prefer different types of exercise. Each weekly exercise session will include 1½ hours of didactic and 1 hour of group exercise. A half day exercise retreat designed to match the meditation retreat will occur the weekend of week 6. The retreat will include didactics, group discussion and activities, and individualized exercise practice.
|
Wait-list Control
n=138 Participants
Apart from not attending any of the specific meditation or exercise training sessions, those in the control group will be treated in essentially the same manner as "experimental" participants.
|
|---|---|---|---|
|
Pro-Inflammatory Cytokines
hsCRP - Baseline
|
1.6 pg/mL
Interval 0.7 to 4.5
|
1.4 pg/mL
Interval 0.6 to 3.9
|
1.5 pg/mL
Interval 0.7 to 4.8
|
|
Pro-Inflammatory Cytokines
hsCRP - December
|
1.7 pg/mL
Interval 0.8 to 4.8
|
1.7 pg/mL
Interval 0.7 to 3.3
|
1.6 pg/mL
Interval 0.7 to 4.4
|
|
Pro-Inflammatory Cytokines
hsCRP - March
|
1.3 pg/mL
Interval 0.7 to 3.3
|
1.3 pg/mL
Interval 0.6 to 3.2
|
1.4 pg/mL
Interval 0.6 to 3.9
|
|
Pro-Inflammatory Cytokines
IL-6 nasal - Baseline
|
1.3 pg/mL
Interval 0.8 to 2.2
|
1.0 pg/mL
Interval 0.6 to 2.1
|
1.1 pg/mL
Interval 0.5 to 2.3
|
|
Pro-Inflammatory Cytokines
IL-6 nasal - December
|
1.7 pg/mL
Interval 0.8 to 3.9
|
1.8 pg/mL
Interval 0.8 to 2.9
|
1.3 pg/mL
Interval 0.6 to 2.8
|
|
Pro-Inflammatory Cytokines
IL-6 nasal - March
|
1.6 pg/mL
Interval 0.9 to 2.6
|
1.6 pg/mL
Interval 0.8 to 2.8
|
1.6 pg/mL
Interval 0.8 to 3.6
|
|
Pro-Inflammatory Cytokines
IL-6 serum - Baseline
|
1.6 pg/mL
Interval 1.0 to 2.8
|
1.8 pg/mL
Interval 1.1 to 2.9
|
1.7 pg/mL
Interval 1.0 to 2.9
|
|
Pro-Inflammatory Cytokines
IL-6 serum - December
|
1.6 pg/mL
Interval 0.9 to 3.2
|
1.7 pg/mL
Interval 1.0 to 3.0
|
1.5 pg/mL
Interval 1.0 to 2.6
|
|
Pro-Inflammatory Cytokines
IL-6 serum - March
|
1.7 pg/mL
Interval 0.9 to 2.6
|
1.6 pg/mL
Interval 0.9 to 2.5
|
1.8 pg/mL
Interval 1.1 to 3.0
|
|
Pro-Inflammatory Cytokines
IP-10 - Baseline
|
141 pg/mL
Interval 117.0 to 183.0
|
156 pg/mL
Interval 126.0 to 198.0
|
152 pg/mL
Interval 127.0 to 198.0
|
|
Pro-Inflammatory Cytokines
IP-10 - December
|
140 pg/mL
Interval 116.0 to 183.0
|
139 pg/mL
Interval 116.0 to 172.0
|
148 pg/mL
Interval 121.0 to 205.0
|
|
Pro-Inflammatory Cytokines
IP-10 - March
|
149 pg/mL
Interval 114.0 to 192.0
|
145 pg/mL
Interval 111.0 to 190.0
|
147 pg/mL
Interval 123.0 to 192.0
|
|
Pro-Inflammatory Cytokines
IL-8 - Baseline
|
167 pg/mL
Interval 86.0 to 313.0
|
157 pg/mL
Interval 79.0 to 271.0
|
194 pg/mL
Interval 87.0 to 352.0
|
|
Pro-Inflammatory Cytokines
IL-8 - December
|
238 pg/mL
Interval 144.0 to 356.0
|
214 pg/mL
Interval 127.0 to 354.0
|
255 pg/mL
Interval 140.0 to 446.0
|
|
Pro-Inflammatory Cytokines
IL-8 - March
|
258 pg/mL
Interval 157.0 to 424.0
|
227 pg/mL
Interval 158.0 to 414.0
|
248 pg/mL
Interval 155.0 to 390.0
|
Adverse Events
Mindfulness Meditation
Serious events: 0 serious events
Other events: 10 other events
Deaths: 0 deaths
Exercise
Serious events: 0 serious events
Other events: 20 other events
Deaths: 0 deaths
Wait-list Control
Serious events: 0 serious events
Other events: 16 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Mindfulness Meditation
n=138 participants at risk
Training will consist of a standardized 8-week Mindfulness Based Stress Reduction (MBSR) program, including 2½ hour weekly sessions and approximately 45 minutes per day at-home daily practice.
Mindfulness Meditation: Training will consist of a standardized 8-week Mindfulness Based Stress Reduction (MBSR) program, including 2½ hour weekly sessions and regular at-home daily practice. Didactic sessions center on awareness of physical, emotional, cognitive, and interpersonal responses to stress. A half day meditation "retreat" on a weekend day at the end of week 6 will allow participants to practice their skills.
|
Exercise
n=137 participants at risk
The exercise intervention structure is consistent with many standardized exercise programs. The exercise program will match the meditation program in duration (8 weeks), attention (weekly 2½ hour group sessions), and intensity (daily 45 minute at-home practice).
Exercise: Exercise training will primarily focus on walking or jogging, activities that are convenient, easy to teach and do not require special equipment. Individualized programs will be developed for those who have access to specific equipment, are unable to do walking/jogging, or prefer different types of exercise. Each weekly exercise session will include 1½ hours of didactic and 1 hour of group exercise. A half day exercise retreat designed to match the meditation retreat will occur the weekend of week 6. The retreat will include didactics, group discussion and activities, and individualized exercise practice.
|
Wait-list Control
n=138 participants at risk
Apart from not attending any of the specific meditation or exercise training sessions, those in the control group will be treated in essentially the same manner as "experimental" participants.
|
|---|---|---|---|
|
Cardiac disorders
Cardiac Disorders
|
0.72%
1/138 • Number of events 1 • Each cohort was followed for no more than 10 months (August through June).
|
5.8%
8/137 • Number of events 8 • Each cohort was followed for no more than 10 months (August through June).
|
0.72%
1/138 • Number of events 1 • Each cohort was followed for no more than 10 months (August through June).
|
|
General disorders
General
|
3.6%
5/138 • Number of events 5 • Each cohort was followed for no more than 10 months (August through June).
|
5.1%
7/137 • Number of events 7 • Each cohort was followed for no more than 10 months (August through June).
|
5.8%
8/138 • Number of events 8 • Each cohort was followed for no more than 10 months (August through June).
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal
|
7.2%
10/138 • Number of events 10 • Each cohort was followed for no more than 10 months (August through June).
|
9.5%
13/137 • Number of events 13 • Each cohort was followed for no more than 10 months (August through June).
|
11.6%
16/138 • Number of events 16 • Each cohort was followed for no more than 10 months (August through June).
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place