Breast Cancer, Depression, Fatigue, Pain
Conditions
Keywords
fatigue, depression, pain, cancer survivor, stage IA breast cancer, stage IB breast cancer, stage II breast cancer, stage IIIA breast cancer, breast cancer in situ
Brief summary
RATIONALE: Yoga may improve inflammation, fatigue, and depression in female breast cancer survivors. PURPOSE: This randomized clinical trial is studying how well Hatha yoga works in improving physical activity, inflammation, fatigue, and distress in female breast cancer survivors.
Detailed description
OBJECTIVES: Primary * To determine if the yoga intervention will decrease inflammation, fatigue, and depressive symptoms relative to the waiting-list controls in women who are stage 0-IIIa breast cancer survivors. OUTLINE: Patients are stratified according to stage of cancer (stage 0 vs stage I vs stage II and stage IIIA) and prior radiation therapy (yes vs no). Patients are randomized to 1 of 2 intervention arms. * Arm I (waiting-list control): Patients are encouraged to perform usual activities, but asked to refrain from any yoga practice or other related activities. After a six-month observation period, patients undergo yoga intervention as described in arm II . * Arm II (yoga intervention): Patients participate in a Hatha yoga intervention session comprising body postures and breath control techniques for 1.5 hours twice a week for 12 weeks. Patients are encouraged to practice Hatha yoga at home. Patients complete daily diaries on home Hatha yoga practices and submit them at each session.
Interventions
PROCEDUREYoga Therapy
Patients will undergo yoga therapy
Sponsors
National Cancer Institute (NCI)
Ohio State University Comprehensive Cancer Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
21 Years to No maximum
Healthy volunteers
No
Inclusion criteria
DISEASE CHARACTERISTICS: * Stage 0-IIIA breast cancer survivor * Completed cancer treatment within the past 36 months (except for tamoxifen/aromatase inhibitors) * At least 2 months since prior surgery, adjuvant therapy, or radiotherapy, whichever occurred last * Women who are not currently practicing yoga and have not participated in any of the following activities: * Meditation, tai chi, or related activities * Yoga or tai chi within the past 6 months * Had classes for or practiced yoga for more than 3 months * Women who typically engage in a total of 5 or more hours of vigorous physical activity per week are not eligible * No inflammatory breast cancer PATIENT CHARACTERISTICS: Inclusion criteria: * Hemoglobin ≥ 10 g/dL (patients with a hemoglobin of \< 10 g/dL may be retested in 6 weeks after treatment of anemia and allowed to participate in study if blood counts recovered) * Physically able to fully participate in yoga intervention
Exclusion criteria
* Inability to comfortably get up and down from the floor 2-3 times in a session * Breathing problems requiring use of oxygen * Problems walking without a cane or walker assistance * Prior knee or hip replacement with limited movement in the joint * Inability to comfortably lie on the stomach * Alcohol, or drug abuse * Diagnosis of any of the following conditions: * Diabetes * Chronic obstructive pulmonary disease * Uncontrolled hypertension * Evidence of liver or kidney failure * Symptomatic ischemic heart disease * Significant visual or auditory problems * Mental disorder or cognitive impairment * Notable serious cardiovascular history (e.g., prior life-threatening abnormal heart rhythms) * Other medical conditions involving the immune system such as autoimmune and/or inflammatory diseases including rheumatoid arthritis and ulcerative colitis * History of breast or any other cancer, except basal or squamous cell skin cancer PRIOR CONCURRENT THERAPY: * See Disease Characteristics * No regular use of medications with major immunological consequences (e.g., steroids)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Stimulated ln (TNF-a) | Immediately post-treatment and 3 months post-treatment | log-transformed Lipopolysaccharide (LPS) stimulated Tumor Necrosis Factor-alpha (TNF-alpha) |
| Stimulated ln (IL-6) | Immediately post-treatment and 3 months post-treatment | log-transformed Lipopolysaccharide (LPS) stimulated Interleukin-6 (IL-6) |
| Stimulated ln (IL-1b) | Immediately post-treatment and 3 months post-treatment | log-transformed Lipopolysaccharide (LPS) stimulated Interleukin-1 beta (IL-1b) |
| MFSI-SF Fatigue | Immediately post-treatment and 3 months post-treatment | 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. |
| Vitality, SF-36 | Immediately post-treatment and 3 months post-treatment | 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. |
| CES-D | Immediately post-treatment and 3 months post-treatment | 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. |
Countries
United States
Participant flow
Recruitment details
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.
Pre-assignment details
We assessed functional limitations during the screening session. Those who had mobility/functional limitations were dropped out before randomization.
Participants by arm
| Arm | Count |
|---|---|
| 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. | 100 |
| 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. | 100 |
| Total | 200 |
Baseline characteristics
| Characteristic | Arm I: Yoga Therapy | Arm II: Wait-List | Total |
|---|---|---|---|
| Age, Continuous | 51.8 years STANDARD_DEVIATION 9.8 | 51.3 years STANDARD_DEVIATION 8.7 | 51.6 years STANDARD_DEVIATION 9.2 |
| BMI | 27.9 kg/m^2 STANDARD_DEVIATION 5.3 | 27.6 kg/m^2 STANDARD_DEVIATION 6 | 27.8 kg/m^2 STANDARD_DEVIATION 5.7 |
| Cancer Stage Stage 0 | 9 participants | 9 participants | 18 participants |
| Cancer Stage Stage I | 46 participants | 43 participants | 89 participants |
| Cancer Stage Stage IIA | 27 participants | 25 participants | 52 participants |
| Cancer Stage Stage IIB | 10 participants | 13 participants | 23 participants |
| Cancer Stage Stage IIIA | 8 participants | 10 participants | 18 participants |
| CES-D depressive symptoms | 10.2 units on a scale STANDARD_DEVIATION 8.2 | 11.2 units on a scale STANDARD_DEVIATION 8.2 | 10.7 units on a scale STANDARD_DEVIATION 8.2 |
| CHAMPS activity | 6.8 total hours/week STANDARD_DEVIATION 6.3 | 5.8 total hours/week STANDARD_DEVIATION 5.1 | 6.3 total hours/week STANDARD_DEVIATION 5.7 |
| Education level College Grad | 29 participants | 33 participants | 62 participants |
| Education level High School or Less | 5 participants | 7 participants | 12 participants |
| Education level Postgraduate | 39 participants | 38 participants | 77 participants |
| Education level Some College | 27 participants | 22 participants | 49 participants |
| Employment Status Employed full or part time | 71 participants | 66 participants | 137 participants |
| Employment Status Retired | 14 participants | 14 participants | 28 participants |
| Employment Status Unemployed | 15 participants | 20 participants | 35 participants |
| Estrogen Receptor Status Negative | 15 participants | 17 participants | 32 participants |
| Estrogen Receptor Status Positive | 81 participants | 78 participants | 159 participants |
| Estrogen Receptor Status Unknown | 4 participants | 5 participants | 9 participants |
| Ethnicity Asian | 3 participants | 2 participants | 5 participants |
| Ethnicity Black or African American | 8 participants | 10 participants | 18 participants |
| Ethnicity Not Reported | 1 participants | 0 participants | 1 participants |
| Ethnicity White | 88 participants | 88 participants | 176 participants |
| HER2 Receptor Status Negative | 74 participants | 72 participants | 146 participants |
| HER2 Receptor Status Positive | 18 participants | 17 participants | 35 participants |
| HER2 Receptor Status Unknown | 8 participants | 11 participants | 19 participants |
| Income level $0-$25,000 | 3 participants | 7 participants | 10 participants |
| Income level >$100,000 | 30 participants | 29 participants | 59 participants |
| Income level $25,000-$50,000 | 18 participants | 15 participants | 33 participants |
| Income level $50,000-$75,000 | 17 participants | 18 participants | 35 participants |
| Income level $75,000-$100,000 | 23 participants | 23 participants | 46 participants |
| Income level No report | 9 participants | 8 participants | 17 participants |
| Marital Status Married | 68 participants | 72 participants | 140 participants |
| Marital Status Separated/Divorced | 14 participants | 15 participants | 29 participants |
| Marital Status Single | 18 participants | 8 participants | 26 participants |
| Marital Status Widowed | 0 participants | 5 participants | 5 participants |
| MFSI-SF Fatigue | 14.3 units on a scale STANDARD_DEVIATION 19.6 | 17.3 units on a scale STANDARD_DEVIATION 20.5 | 15.8 units on a scale STANDARD_DEVIATION 20.1 |
| Post-menopausal | 76 participants | 77 participants | 153 participants |
| Progesterone Receptor Status Negative | 23 participants | 26 participants | 49 participants |
| Progesterone Receptor Status Positive | 73 participants | 69 participants | 142 participants |
| Progesterone Receptor Status Unknown | 4 participants | 5 participants | 9 participants |
| SAD | 20.7 cm STANDARD_DEVIATION 3.3 | 21.0 cm STANDARD_DEVIATION 3.6 | 20.8 cm STANDARD_DEVIATION 3.4 |
| Sex: Female, Male Female | 100 Participants | 100 Participants | 200 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants |
| SF-36 Vitality | 48.6 units on a scale STANDARD_DEVIATION 20.2 | 44.4 units on a scale STANDARD_DEVIATION 20.9 | 46.5 units on a scale STANDARD_DEVIATION 20.6 |
| Time since diagnosis | 16.3 months STANDARD_DEVIATION 7.5 | 18.4 months STANDARD_DEVIATION 8.5 | 17.3 months STANDARD_DEVIATION 8.1 |
| Time since treatment | 9.9 months STANDARD_DEVIATION 7.1 | 11.8 months STANDARD_DEVIATION 8.5 | 10.9 months STANDARD_DEVIATION 7.9 |
| Type of Treatment Surgery + Chemotherapy | 23 participants | 23 participants | 46 participants |
| Type of Treatment Surgery Only | 13 participants | 13 participants | 26 participants |
| Type of Treatment Surgery + Radiation | 28 participants | 24 participants | 52 participants |
| Type of Treatment Surgery + Radiation + Chemotherapy | 36 participants | 40 participants | 76 participants |
| Usage of Cardiac Medication | 17 participants | 16 participants | 33 participants |
| Usage of Tamoxifen/Aromatase Inhibitors | 72 participants | 71 participants | 143 participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 2 / 100 | 0 / 100 |
| serious Total, serious adverse events | 0 / 100 | 0 / 100 |
Outcome results
Primary
CES-D
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.
Time frame: Immediately post-treatment and 3 months post-treatment
Population: Any subjects who do not have any measurements post-baseline are excluded from analyses.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Arm I: Yoga Therapy | CES-D | Immediately post-treatment | 8.1 units on a scale | Standard Error 0.69 |
| Arm I: Yoga Therapy | CES-D | 3 months post-treatment | 8.5 units on a scale | Standard Error 0.69 |
| Arm II: Wait-List | CES-D | Immediately post-treatment | 9.2 units on a scale | Standard Error 0.7 |
| Arm II: Wait-List | CES-D | 3 months post-treatment | 9.7 units on a scale | Standard Error 0.71 |
Comparison: Mixed effect models were used to test the intervention's effect on primary outcomes. Fixed effects included visit, intervention group, their interaction, and baseline outcome levels. Random effects included a subject-specific random intercept, accounting for within-subject correlation, and a random effect for yoga-group, accounting for the partially-nested data arising from small groups being present in the intervention arm but not in the control arm.p-value: 0.2895% CI: [-3, 0.88]Mixed Models Analysis
Comparison: Mixed effect models were used to test the intervention's effect on primary outcomes. Fixed effects included visit, intervention group, their interaction, and baseline outcome levels. Random effects included a subject-specific random intercept, accounting for within-subject correlation, and a random effect for yoga-group, accounting for the partially-nested data arising from small groups being present in the intervention arm but not in the control arm.p-value: 0.2195% CI: [-3.2, 0.69]Mixed Models Analysis
Comparison: Secondary analysis on change of CES-D for each 10 minute increase in yoga practice frequency, adjusting for baseline outcome levels, age, and SAD.p-value: 0.05195% CI: [-1.3, 0.0039]Mixed Models Analysis
Comparison: Secondary analysis on change of CESD for each 10 minute increase in yoga practice frequency, adjusting for baseline outcome levels, age, and SAD.p-value: 0.09895% CI: [-1.2, 0.1]Mixed Models Analysis
Primary
MFSI-SF Fatigue
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.
Time frame: Immediately post-treatment and 3 months post-treatment
Population: Any subjects who do not have any measurements post-baseline are excluded from analyses.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Arm I: Yoga Therapy | MFSI-SF Fatigue | Immediately post-treatment | 6.1 units on a scale | Standard Error 1.7 |
| Arm I: Yoga Therapy | MFSI-SF Fatigue | 3 months post-treatment | 5.4 units on a scale | Standard Error 1.7 |
| Arm II: Wait-List | MFSI-SF Fatigue | Immediately post-treatment | 10.3 units on a scale | Standard Error 1.4 |
| Arm II: Wait-List | MFSI-SF Fatigue | 3 months post-treatment | 12.4 units on a scale | Standard Error 1.4 |
Comparison: Mixed effect models were used to test the intervention's effect on primary outcomes. Fixed effects included visit, intervention group, their interaction, and baseline outcome levels. Random effects included a subject-specific random intercept, accounting for within-subject correlation, and a random effect for yoga-group, accounting for the partially-nested data arising from small groups being present in the intervention arm but not in the control arm.p-value: 0.05895% CI: [-8.5, 0.15]Mixed Models Analysis
Comparison: Mixed effect models were used to test the intervention's effect on primary outcomes. Fixed effects included visit, intervention group, their interaction, and baseline outcome levels. Random effects included a subject-specific random intercept, accounting for within-subject correlation, and a random effect for yoga-group, accounting for the partially-nested data arising from small groups being present in the intervention arm but not in the control arm.p-value: 0.00295% CI: [-11.4, -2.7]Mixed Models Analysis
Comparison: Secondary analysis on change of MFSI-SF Fatigue for each 10 minute increase in yoga practice frequency, adjusting for baseline outcome levels, age, and SAD.p-value: 0.01995% CI: [-3.1, -0.28]Mixed Models Analysis
Comparison: Secondary analysis on change of MFSI-SF fatigue for each 10 minute increase in yoga practice frequency, adjusting for baseline outcome levels, age, and SAD.p-value: 0.000195% CI: [-4.2, -1.4]Mixed Models Analysis
Primary
Stimulated ln (IL-1b)
log-transformed Lipopolysaccharide (LPS) stimulated Interleukin-1 beta (IL-1b)
Time frame: Immediately post-treatment and 3 months post-treatment
Population: Any subjects who do not have any measurements post-baseline are excluded from analyses.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Arm I: Yoga Therapy | Stimulated ln (IL-1b) | Immediately post-treatment | 8.31 ln (pg/mL) | Standard Error 0.077 |
| Arm I: Yoga Therapy | Stimulated ln (IL-1b) | 3 months post-treatment | 8.32 ln (pg/mL) | Standard Error 0.079 |
| Arm II: Wait-List | Stimulated ln (IL-1b) | Immediately post-treatment | 8.42 ln (pg/mL) | Standard Error 0.071 |
| Arm II: Wait-List | Stimulated ln (IL-1b) | 3 months post-treatment | 8.55 ln (pg/mL) | Standard Error 0.074 |
Comparison: Mixed effect models were used to test the intervention's effect on primary outcomes. Fixed effects included visit, intervention group, their interaction, and baseline outcome levels. Random effects included a subject-specific random intercept, accounting for within-subject correlation, and a random effect for yoga-group, accounting for the partially-nested data arising from small groups being present in the intervention arm but not in the control arm.p-value: 0.3395% CI: [-0.31, 0.11]Mixed Models Analysis
Comparison: Mixed effect models were used to test the intervention's effect on primary outcomes. Fixed effects included visit, intervention group, their interaction, and baseline outcome levels. Random effects included a subject-specific random intercept, accounting for within-subject correlation, and a random effect for yoga-group, accounting for the partially-nested data arising from small groups being present in the intervention arm but not in the control arm.p-value: 0.03795% CI: [-0.44, -0.014]Mixed Models Analysis
Comparison: Secondary analysis on change of ln (IL-1b) for each 10 minute increase in yoga practice frequency, adjusting for baseline outcome levels, age, and SAD.p-value: 0.3395% CI: [-0.1, 0.035]Mixed Models Analysis
Comparison: Secondary analysis on change of ln (IL-1b) for each 10 minute increase in yoga practice frequency, adjusting for baseline outcome levels, age, and SAD.p-value: 0.0395% CI: [-0.15, -0.0074]Mixed Models Analysis
Primary
Stimulated ln (IL-6)
log-transformed Lipopolysaccharide (LPS) stimulated Interleukin-6 (IL-6)
Time frame: Immediately post-treatment and 3 months post-treatment
Population: Any subjects who do not have any measurements post-baseline are excluded from analyses.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Arm I: Yoga Therapy | Stimulated ln (IL-6) | Immediately post-treatment | 9.68 ln (pg/mL) | Standard Error 0.043 |
| Arm I: Yoga Therapy | Stimulated ln (IL-6) | 3 months post-treatment | 9.69 ln (pg/mL) | Standard Error 0.044 |
| Arm II: Wait-List | Stimulated ln (IL-6) | Immediately post-treatment | 9.76 ln (pg/mL) | Standard Error 0.044 |
| Arm II: Wait-List | Stimulated ln (IL-6) | 3 months post-treatment | 9.85 ln (pg/mL) | Standard Error 0.047 |
Comparison: Secondary analysis on change of ln (IL-6) for each 10 minute increase in yoga practice frequency, adjusting for baseline outcome levels, age, and SAD.p-value: 0.395% CI: [-0.063, 0.019]Mixed Models Analysis
Comparison: Secondary analysis on change of ln (IL-6) for each 10 minute increase in yoga practice frequency, adjusting for baseline outcome levels, age, and SAD.p-value: 0.0195% CI: [-0.098, -0.013]Mixed Models Analysis
Comparison: Mixed effect models were used to test the intervention's effect on primary outcomes. Fixed effects included visit, intervention group, their interaction, and baseline outcome levels. Random effects included a subject-specific random intercept, accounting for within-subject correlation, and a random effect for yoga-group, accounting for the partially-nested data arising from small groups being present in the intervention arm but not in the control arm.p-value: 0.295% CI: [-0.2, -0.042]Mixed Models Analysis
Comparison: Mixed effect models were used to test the intervention's effect on primary outcomes. Fixed effects included visit, intervention group, their interaction, and baseline outcome levels. Random effects included a subject-specific random intercept, accounting for within-subject correlation, and a random effect for yoga-group, accounting for the partially-nested data arising from small groups being present in the intervention arm but not in the control arm.p-value: 0.01595% CI: [-0.28, -0.031]Mixed Models Analysis
Primary
Stimulated ln (TNF-a)
log-transformed Lipopolysaccharide (LPS) stimulated Tumor Necrosis Factor-alpha (TNF-alpha)
Time frame: Immediately post-treatment and 3 months post-treatment
Population: Any subjects who do not have any measurements post-baseline are excluded from analyses.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Arm I: Yoga Therapy | Stimulated ln (TNF-a) | Immediately post-treatment | 8.31 ln (pg/mL) | Standard Error 0.041 |
| Arm I: Yoga Therapy | Stimulated ln (TNF-a) | 3 months post-treatment | 8.31 ln (pg/mL) | Standard Error 0.042 |
| Arm II: Wait-List | Stimulated ln (TNF-a) | Immediately post-treatment | 8.39 ln (pg/mL) | Standard Error 0.04 |
| Arm II: Wait-List | Stimulated ln (TNF-a) | 3 months post-treatment | 8.44 ln (pg/mL) | Standard Error 0.043 |
Comparison: Mixed effect models were used to test the intervention's effect on primary outcomes. Fixed effects included visit, intervention group, their interaction, and baseline outcome levels. Random effects included a subject-specific random intercept, accounting for within-subject correlation, and a random effect for yoga-group, accounting for the partially-nested data arising from small groups being present in the intervention arm but not in the control arm.p-value: 0.295% CI: [-0.19, 0.039]Mixed Models Analysis
Comparison: Mixed effect models were used to test the intervention's effect on primary outcomes. Fixed effects included visit, intervention group, their interaction, and baseline outcome levels. Random effects included a subject-specific random intercept, accounting for within-subject correlation, and a random effect for yoga-group, accounting for the partially-nested data arising from small groups being present in the intervention arm but not in the control arm.p-value: 0.02795% CI: [-0.25, -0.015]Mixed Models Analysis
Comparison: Secondary analysis on change of ln (TNF-a) for each 10 minute increase in yoga practice frequency, adjusting for baseline outcome levels, age, and SAD.p-value: 0.2895% CI: [-0.06, 0.018]Mixed Models Analysis
Comparison: Secondary analysis on change of ln (TNF-a) for each 10 minute increase in yoga practice frequency, adjusting for baseline outcome levels, age, and SAD.p-value: 0.06395% CI: [-0.079, 0.0021]Mixed Models Analysis
Primary
Vitality, SF-36
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.
Time frame: Immediately post-treatment and 3 months post-treatment
Population: Any subjects who do not have any measurements post-baseline are excluded from analyses.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Arm I: Yoga Therapy | Vitality, SF-36 | Immediately post-treatment | 58.7 units on a scale | Standard Error 1.9 |
| Arm I: Yoga Therapy | Vitality, SF-36 | 3 months post-treatment | 58.1 units on a scale | Standard Error 1.9 |
| Arm II: Wait-List | Vitality, SF-36 | Immediately post-treatment | 52.3 units on a scale | Standard Error 1.7 |
| Arm II: Wait-List | Vitality, SF-36 | 3 months post-treatment | 51.6 units on a scale | Standard Error 1.7 |
Comparison: Mixed effect models were used to test the intervention's effect on primary outcomes. Fixed effects included visit, intervention group, their interaction, and baseline outcome levels. Random effects included a subject-specific random intercept, accounting for within-subject correlation, and a random effect for yoga-group, accounting for the partially-nested data arising from small groups being present in the intervention arm but not in the control arm.p-value: 0.0195% CI: [1.4, 11.4]Mixed Models Analysis
Comparison: Mixed effect models were used to test the intervention's effect on primary outcomes. Fixed effects included visit, intervention group, their interaction, and baseline outcome levels. Random effects included a subject-specific random intercept, accounting for within-subject correlation, and a random effect for yoga-group, accounting for the partially-nested data arising from small groups being present in the intervention arm but not in the control arm.p-value: 0.0195% CI: [1.5, 11.6]Mixed Models Analysis
Comparison: Secondary analysis on change of vitality (SF-36) for each 10 minute increase in yoga practice frequency, adjusting for baseline outcome levels, age, and SAD.p-value: 0.01695% CI: [0.4, 3.75]Mixed Models Analysis
Comparison: Secondary analysis on change of vitality (SF-36) for each 10 minute increase in yoga practice frequency, adjusting for baseline outcome levels, age, and SAD.p-value: 0.004595% CI: [0.77, 4.14]Mixed Models Analysis