Trial Outcomes & Findings for Hatha Yoga in Improving Physical Activity, Inflammation, Fatigue, and Distress in Breast Cancer Survivors (NCT NCT00486525)
NCT ID: NCT00486525
Last Updated: 2014-05-05
Results Overview
log-transformed Lipopolysaccharide (LPS) stimulated Tumor Necrosis Factor-alpha (TNF-alpha)
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
200 participants
Primary outcome timeframe
Immediately post-treatment and 3 months post-treatment
Results posted on
2014-05-05
Participant Flow
We enrolled a sample of 200 breast cancer survivors with respect to age, stage of cancer, and treatment modalities between October 2007 and April 2012 in the Ohio State University Medical Center. Women were recruited through oncologists' referrals, community print and web-based announcements, and breast cancer groups and events.
We assessed functional limitations during the screening session. Those who had mobility/functional limitations were dropped out before randomization.
Participant milestones
| Measure |
Arm I: Yoga Therapy
Patients participated in a Hatha yoga session over 90 minutes twice weekly for 12 weeks. Patients were also encouraged to practice yoga at home. Patients recorded their total home/class practice time in weekly logs.
|
Arm II: Wait-List
Wait-listed women were told to continue performing their usual activities, and to refrain from beginning any yoga practice. After their final assessment they were offered the yoga classes.
|
|---|---|---|
|
Overall Study
STARTED
|
100
|
100
|
|
Overall Study
COMPLETED
|
94
|
87
|
|
Overall Study
NOT COMPLETED
|
6
|
13
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Hatha Yoga in Improving Physical Activity, Inflammation, Fatigue, and Distress in Breast Cancer Survivors
Baseline characteristics by cohort
| Measure |
Arm I: Yoga Therapy
n=100 Participants
Patients participated in a Hatha yoga session over 90 minutes twice weekly for 12 weeks. Patients were also encouraged to practice yoga at home. Patients recorded their total home/class practice time in weekly logs.
|
Arm II: Wait-List
n=100 Participants
Wait-listed women were told to continue performing their usual activities, and to refrain from beginning any yoga practice. After their final assessment they were offered the yoga classes.
|
Total
n=200 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
51.8 years
STANDARD_DEVIATION 9.8 • n=99 Participants
|
51.3 years
STANDARD_DEVIATION 8.7 • n=107 Participants
|
51.6 years
STANDARD_DEVIATION 9.2 • n=206 Participants
|
|
Sex: Female, Male
Female
|
100 Participants
n=99 Participants
|
100 Participants
n=107 Participants
|
200 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
BMI
|
27.9 kg/m^2
STANDARD_DEVIATION 5.3 • n=99 Participants
|
27.6 kg/m^2
STANDARD_DEVIATION 6.0 • n=107 Participants
|
27.8 kg/m^2
STANDARD_DEVIATION 5.7 • n=206 Participants
|
|
SAD
|
20.7 cm
STANDARD_DEVIATION 3.3 • n=99 Participants
|
21.0 cm
STANDARD_DEVIATION 3.6 • n=107 Participants
|
20.8 cm
STANDARD_DEVIATION 3.4 • n=206 Participants
|
|
Ethnicity
Asian
|
3 participants
n=99 Participants
|
2 participants
n=107 Participants
|
5 participants
n=206 Participants
|
|
Ethnicity
Black or African American
|
8 participants
n=99 Participants
|
10 participants
n=107 Participants
|
18 participants
n=206 Participants
|
|
Ethnicity
White
|
88 participants
n=99 Participants
|
88 participants
n=107 Participants
|
176 participants
n=206 Participants
|
|
Ethnicity
Not Reported
|
1 participants
n=99 Participants
|
0 participants
n=107 Participants
|
1 participants
n=206 Participants
|
|
CES-D depressive symptoms
|
10.2 units on a scale
STANDARD_DEVIATION 8.2 • n=99 Participants
|
11.2 units on a scale
STANDARD_DEVIATION 8.2 • n=107 Participants
|
10.7 units on a scale
STANDARD_DEVIATION 8.2 • n=206 Participants
|
|
Usage of Cardiac Medication
|
17 participants
n=99 Participants
|
16 participants
n=107 Participants
|
33 participants
n=206 Participants
|
|
CHAMPS activity
|
6.8 total hours/week
STANDARD_DEVIATION 6.3 • n=99 Participants
|
5.8 total hours/week
STANDARD_DEVIATION 5.1 • n=107 Participants
|
6.3 total hours/week
STANDARD_DEVIATION 5.7 • n=206 Participants
|
|
MFSI-SF Fatigue
|
14.3 units on a scale
STANDARD_DEVIATION 19.6 • n=99 Participants
|
17.3 units on a scale
STANDARD_DEVIATION 20.5 • n=107 Participants
|
15.8 units on a scale
STANDARD_DEVIATION 20.1 • n=206 Participants
|
|
SF-36 Vitality
|
48.6 units on a scale
STANDARD_DEVIATION 20.2 • n=99 Participants
|
44.4 units on a scale
STANDARD_DEVIATION 20.9 • n=107 Participants
|
46.5 units on a scale
STANDARD_DEVIATION 20.6 • n=206 Participants
|
|
Marital Status
Single
|
18 participants
n=99 Participants
|
8 participants
n=107 Participants
|
26 participants
n=206 Participants
|
|
Marital Status
Married
|
68 participants
n=99 Participants
|
72 participants
n=107 Participants
|
140 participants
n=206 Participants
|
|
Marital Status
Separated/Divorced
|
14 participants
n=99 Participants
|
15 participants
n=107 Participants
|
29 participants
n=206 Participants
|
|
Marital Status
Widowed
|
0 participants
n=99 Participants
|
5 participants
n=107 Participants
|
5 participants
n=206 Participants
|
|
Education level
High School or Less
|
5 participants
n=99 Participants
|
7 participants
n=107 Participants
|
12 participants
n=206 Participants
|
|
Education level
Some College
|
27 participants
n=99 Participants
|
22 participants
n=107 Participants
|
49 participants
n=206 Participants
|
|
Education level
College Grad
|
29 participants
n=99 Participants
|
33 participants
n=107 Participants
|
62 participants
n=206 Participants
|
|
Education level
Postgraduate
|
39 participants
n=99 Participants
|
38 participants
n=107 Participants
|
77 participants
n=206 Participants
|
|
Employment Status
Employed full or part time
|
71 participants
n=99 Participants
|
66 participants
n=107 Participants
|
137 participants
n=206 Participants
|
|
Employment Status
Unemployed
|
15 participants
n=99 Participants
|
20 participants
n=107 Participants
|
35 participants
n=206 Participants
|
|
Employment Status
Retired
|
14 participants
n=99 Participants
|
14 participants
n=107 Participants
|
28 participants
n=206 Participants
|
|
Income level
$0-$25,000
|
3 participants
n=99 Participants
|
7 participants
n=107 Participants
|
10 participants
n=206 Participants
|
|
Income level
$25,000-$50,000
|
18 participants
n=99 Participants
|
15 participants
n=107 Participants
|
33 participants
n=206 Participants
|
|
Income level
$50,000-$75,000
|
17 participants
n=99 Participants
|
18 participants
n=107 Participants
|
35 participants
n=206 Participants
|
|
Income level
$75,000-$100,000
|
23 participants
n=99 Participants
|
23 participants
n=107 Participants
|
46 participants
n=206 Participants
|
|
Income level
>$100,000
|
30 participants
n=99 Participants
|
29 participants
n=107 Participants
|
59 participants
n=206 Participants
|
|
Income level
No report
|
9 participants
n=99 Participants
|
8 participants
n=107 Participants
|
17 participants
n=206 Participants
|
|
Type of Treatment
Surgery Only
|
13 participants
n=99 Participants
|
13 participants
n=107 Participants
|
26 participants
n=206 Participants
|
|
Type of Treatment
Surgery + Radiation
|
28 participants
n=99 Participants
|
24 participants
n=107 Participants
|
52 participants
n=206 Participants
|
|
Type of Treatment
Surgery + Chemotherapy
|
23 participants
n=99 Participants
|
23 participants
n=107 Participants
|
46 participants
n=206 Participants
|
|
Type of Treatment
Surgery + Radiation + Chemotherapy
|
36 participants
n=99 Participants
|
40 participants
n=107 Participants
|
76 participants
n=206 Participants
|
|
Cancer Stage
Stage 0
|
9 participants
n=99 Participants
|
9 participants
n=107 Participants
|
18 participants
n=206 Participants
|
|
Cancer Stage
Stage I
|
46 participants
n=99 Participants
|
43 participants
n=107 Participants
|
89 participants
n=206 Participants
|
|
Cancer Stage
Stage IIA
|
27 participants
n=99 Participants
|
25 participants
n=107 Participants
|
52 participants
n=206 Participants
|
|
Cancer Stage
Stage IIB
|
10 participants
n=99 Participants
|
13 participants
n=107 Participants
|
23 participants
n=206 Participants
|
|
Cancer Stage
Stage IIIA
|
8 participants
n=99 Participants
|
10 participants
n=107 Participants
|
18 participants
n=206 Participants
|
|
HER2 Receptor Status
Positive
|
18 participants
n=99 Participants
|
17 participants
n=107 Participants
|
35 participants
n=206 Participants
|
|
HER2 Receptor Status
Negative
|
74 participants
n=99 Participants
|
72 participants
n=107 Participants
|
146 participants
n=206 Participants
|
|
HER2 Receptor Status
Unknown
|
8 participants
n=99 Participants
|
11 participants
n=107 Participants
|
19 participants
n=206 Participants
|
|
Progesterone Receptor Status
Positive
|
73 participants
n=99 Participants
|
69 participants
n=107 Participants
|
142 participants
n=206 Participants
|
|
Progesterone Receptor Status
Negative
|
23 participants
n=99 Participants
|
26 participants
n=107 Participants
|
49 participants
n=206 Participants
|
|
Progesterone Receptor Status
Unknown
|
4 participants
n=99 Participants
|
5 participants
n=107 Participants
|
9 participants
n=206 Participants
|
|
Estrogen Receptor Status
Positive
|
81 participants
n=99 Participants
|
78 participants
n=107 Participants
|
159 participants
n=206 Participants
|
|
Estrogen Receptor Status
Negative
|
15 participants
n=99 Participants
|
17 participants
n=107 Participants
|
32 participants
n=206 Participants
|
|
Estrogen Receptor Status
Unknown
|
4 participants
n=99 Participants
|
5 participants
n=107 Participants
|
9 participants
n=206 Participants
|
|
Usage of Tamoxifen/Aromatase Inhibitors
|
72 participants
n=99 Participants
|
71 participants
n=107 Participants
|
143 participants
n=206 Participants
|
|
Post-menopausal
|
76 participants
n=99 Participants
|
77 participants
n=107 Participants
|
153 participants
n=206 Participants
|
|
Time since diagnosis
|
16.3 months
STANDARD_DEVIATION 7.5 • n=99 Participants
|
18.4 months
STANDARD_DEVIATION 8.5 • n=107 Participants
|
17.3 months
STANDARD_DEVIATION 8.1 • n=206 Participants
|
|
Time since treatment
|
9.9 months
STANDARD_DEVIATION 7.1 • n=99 Participants
|
11.8 months
STANDARD_DEVIATION 8.5 • n=107 Participants
|
10.9 months
STANDARD_DEVIATION 7.9 • n=206 Participants
|
PRIMARY outcome
Timeframe: Immediately post-treatment and 3 months post-treatmentPopulation: Any subjects who do not have any measurements post-baseline are excluded from analyses.
log-transformed Lipopolysaccharide (LPS) stimulated Tumor Necrosis Factor-alpha (TNF-alpha)
Outcome measures
| Measure |
Arm I: Yoga Therapy
n=92 Participants
Patients participated in a Hatha yoga session over 90 minutes twice weekly for 12 weeks. Patients were also encouraged to practice yoga at home. Patients recorded their total home/class practice time in weekly logs.
|
Arm II: Wait-List
n=84 Participants
Wait-listed women were told to continue performing their usual activities, and to refrain from beginning any yoga practice. After their final assessment they were offered the yoga classes.
|
|---|---|---|
|
Stimulated ln (TNF-a)
Immediately post-treatment
|
8.31 ln (pg/mL)
Standard Error 0.041
|
8.39 ln (pg/mL)
Standard Error 0.040
|
|
Stimulated ln (TNF-a)
3 months post-treatment
|
8.31 ln (pg/mL)
Standard Error 0.042
|
8.44 ln (pg/mL)
Standard Error 0.043
|
PRIMARY outcome
Timeframe: Immediately post-treatment and 3 months post-treatmentPopulation: Any subjects who do not have any measurements post-baseline are excluded from analyses.
log-transformed Lipopolysaccharide (LPS) stimulated Interleukin-6 (IL-6)
Outcome measures
| Measure |
Arm I: Yoga Therapy
n=92 Participants
Patients participated in a Hatha yoga session over 90 minutes twice weekly for 12 weeks. Patients were also encouraged to practice yoga at home. Patients recorded their total home/class practice time in weekly logs.
|
Arm II: Wait-List
n=84 Participants
Wait-listed women were told to continue performing their usual activities, and to refrain from beginning any yoga practice. After their final assessment they were offered the yoga classes.
|
|---|---|---|
|
Stimulated ln (IL-6)
Immediately post-treatment
|
9.68 ln (pg/mL)
Standard Error 0.043
|
9.76 ln (pg/mL)
Standard Error 0.044
|
|
Stimulated ln (IL-6)
3 months post-treatment
|
9.69 ln (pg/mL)
Standard Error 0.044
|
9.85 ln (pg/mL)
Standard Error 0.047
|
PRIMARY outcome
Timeframe: Immediately post-treatment and 3 months post-treatmentPopulation: Any subjects who do not have any measurements post-baseline are excluded from analyses.
log-transformed Lipopolysaccharide (LPS) stimulated Interleukin-1 beta (IL-1b)
Outcome measures
| Measure |
Arm I: Yoga Therapy
n=92 Participants
Patients participated in a Hatha yoga session over 90 minutes twice weekly for 12 weeks. Patients were also encouraged to practice yoga at home. Patients recorded their total home/class practice time in weekly logs.
|
Arm II: Wait-List
n=84 Participants
Wait-listed women were told to continue performing their usual activities, and to refrain from beginning any yoga practice. After their final assessment they were offered the yoga classes.
|
|---|---|---|
|
Stimulated ln (IL-1b)
Immediately post-treatment
|
8.31 ln (pg/mL)
Standard Error 0.077
|
8.42 ln (pg/mL)
Standard Error 0.071
|
|
Stimulated ln (IL-1b)
3 months post-treatment
|
8.32 ln (pg/mL)
Standard Error 0.079
|
8.55 ln (pg/mL)
Standard Error 0.074
|
PRIMARY outcome
Timeframe: Immediately post-treatment and 3 months post-treatmentPopulation: Any subjects who do not have any measurements post-baseline are excluded from analyses.
The 30-item Multidimensional Fatigue Symptom Inventory-Short form (MFSI-SF) assesses behavioral, cognitive, physical, and affective expressions of fatigue. Items are rated on a 5-point scale indicating how true each statement was for the respondent during the last week (0=not at all; 4=extremely). The total score represents the sum of the subscales measuring general, physical, emotional, and mental fatigue, minus the vigor scale, providing a possible range of scores from -24 to 96, with higher scores indicating greater fatigue.
Outcome measures
| Measure |
Arm I: Yoga Therapy
n=96 Participants
Patients participated in a Hatha yoga session over 90 minutes twice weekly for 12 weeks. Patients were also encouraged to practice yoga at home. Patients recorded their total home/class practice time in weekly logs.
|
Arm II: Wait-List
n=90 Participants
Wait-listed women were told to continue performing their usual activities, and to refrain from beginning any yoga practice. After their final assessment they were offered the yoga classes.
|
|---|---|---|
|
MFSI-SF Fatigue
Immediately post-treatment
|
6.1 units on a scale
Standard Error 1.7
|
10.3 units on a scale
Standard Error 1.4
|
|
MFSI-SF Fatigue
3 months post-treatment
|
5.4 units on a scale
Standard Error 1.7
|
12.4 units on a scale
Standard Error 1.4
|
PRIMARY outcome
Timeframe: Immediately post-treatment and 3 months post-treatmentPopulation: Any subjects who do not have any measurements post-baseline are excluded from analyses.
The SF-36's (RAND Health Survey) energy/fatigue (vitality) scale focuses on the frequency of feelings of fatigue over the last month. Standardized scores on the RAND SF-36 vigor/vitality scale range from 0-100, with higher scores indicating less fatigue.
Outcome measures
| Measure |
Arm I: Yoga Therapy
n=96 Participants
Patients participated in a Hatha yoga session over 90 minutes twice weekly for 12 weeks. Patients were also encouraged to practice yoga at home. Patients recorded their total home/class practice time in weekly logs.
|
Arm II: Wait-List
n=90 Participants
Wait-listed women were told to continue performing their usual activities, and to refrain from beginning any yoga practice. After their final assessment they were offered the yoga classes.
|
|---|---|---|
|
Vitality, SF-36
Immediately post-treatment
|
58.7 units on a scale
Standard Error 1.9
|
52.3 units on a scale
Standard Error 1.7
|
|
Vitality, SF-36
3 months post-treatment
|
58.1 units on a scale
Standard Error 1.9
|
51.6 units on a scale
Standard Error 1.7
|
PRIMARY outcome
Timeframe: Immediately post-treatment and 3 months post-treatmentPopulation: Any subjects who do not have any measurements post-baseline are excluded from analyses.
The Center for Epidemiological Studies Depression Scale (CES-D) is a self-report scale designed to measure current symptoms of depression rated on a four-point likert scale. Scores range from 0-60, with higher scores indicating a higher frequency of depressive symptoms.
Outcome measures
| Measure |
Arm I: Yoga Therapy
n=96 Participants
Patients participated in a Hatha yoga session over 90 minutes twice weekly for 12 weeks. Patients were also encouraged to practice yoga at home. Patients recorded their total home/class practice time in weekly logs.
|
Arm II: Wait-List
n=90 Participants
Wait-listed women were told to continue performing their usual activities, and to refrain from beginning any yoga practice. After their final assessment they were offered the yoga classes.
|
|---|---|---|
|
CES-D
Immediately post-treatment
|
8.1 units on a scale
Standard Error 0.69
|
9.2 units on a scale
Standard Error 0.70
|
|
CES-D
3 months post-treatment
|
8.5 units on a scale
Standard Error 0.69
|
9.7 units on a scale
Standard Error 0.71
|
Adverse Events
Arm I: Yoga Therapy
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Arm II: Wait-List
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Arm I: Yoga Therapy
n=100 participants at risk
Patients participated in a Hatha yoga session over 90 minutes twice weekly for 12 weeks. Patients were also encouraged to practice yoga at home. Patients recorded their total home/class practice time in weekly logs.
|
Arm II: Wait-List
n=100 participants at risk
Wait-listed women were told to continue performing their usual activities, and to refrain from beginning any yoga practice. After their final assessment they were offered the yoga classes.
|
|---|---|---|
|
Musculoskeletal and connective tissue disorders
Recurrence of chronic back and/or shoulder problems
|
2.0%
2/100 • Post-intervention
|
0.00%
0/100 • Post-intervention
|
Additional Information
Janice Kiecolt-Glaser, Principal Investigator
Ohio State University Comprehensive Cancer Center
Phone: 614-293-3499
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place