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. 2018 Jan 29;2018(1):CD011292. doi: 10.1002/14651858.CD011292.pub2

Blank 2005.

Methods Study design: single‐centre RCT
Number randomised: 18; 9 to intervention, 9 to control
Study start, not reported; stop date, not reported
Length of intervention: 8 weeks
Length of follow‐up: to end of intervention
Country: USA
Participants Age:
  • Ages 48 to 69 years


Stage:
  • Stage I‐III breast cancer


Inclusion criteria:
• Minimum of 8 weeks post chemotherapy
• Oestrogen receptor positive status
• Surgery for lumpectomy, modified mastectomy, or full mastectomy (with/without reconstruction)
• Life expectancy greater than 6 months
• Adequate blood cell counts and kidney, liver, and cardiac function
• Physical and mental ability to attend all yoga training sessions
Exclusion criteria:
• Receiving Herceptin therapy, current steroid therapy, or other known immunomodulating medications
• Pregnancy or current lactation
• Past or current history of another neoplasm, active serious infection, or immune deficiency
 • Documented alcohol or drug abuse
• History of psychiatric disorders requiring use of psychotropic medications
Interventions 9 participants assigned to exercise intervention:
  • Beginning level Iyengar yoga class 3 times per week (2 supervised and 1 home‐based). Attention to alignment and symmetry, use of props, and careful sequencing all improve stamina, strength, flexibility, and confidence, while decreasing stress and side effects.


Adherence: not reported
9 participants assigned to control:
  • Wait‐list control

Outcomes Outcomes:
  • 31‐Question self‐report survey about reasons for participation, feelings of stress, level of physical and mental effort during class sessions, and perceptions about how yoga practice influenced awareness


Numbers of participants assessed:
  • Intervention: at 6 weeks, 9

  • Control: at 6 weeks, 9


Adverse events: not reported
Notes Trial registration link: none available
Trial authors contacted: no
Intention‐to‐treat analysis: unclear
Funding: not reported
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Unclear risk "Women were randomized", but it was unclear how the allocation sequence was generated.
Allocation concealment (selection bias) Unclear risk Whether treatment assignment was concealed from study personnel and participants was not described.
Blinding of participants and personnel (performance bias) 
 All outcomes High risk Owing to the nature of the intervention, it was not possible to conceal allocation to the intervention from participants.
Blinding of outcome assessment (detection bias) 
 All outcomes Unclear risk Blinding of outcome assessments was not described.
Incomplete outcome data (attrition bias) 
 All outcomes Unclear risk It is unclear how many participants were included in each outcome assessment.
Selective reporting (reporting bias) High risk Outcome measures were poorly described and reported. Scores for each question were not reported.
Other bias High risk Outcomes were not assessed at baseline, so it was not possible to assess whether outcomes changed as a result of intervention.