Loudon 2014.
Methods | Randomised controlled trial | |
Participants | Women with diagnosed breast cancer and stage I unilateral secondary lymphoedema of the arm Recruited from community health centres Mean age 57.7 years N = 23 |
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Interventions | • Satyananda yoga (yoga postures, breathing techniques, relaxation techniques, meditation), 8 weeks, once weekly for 90 minutes • Wait‐list, usual care for 8 weeks |
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Outcomes | Health‐related quality of life (Lymphoedema Quality of Life Tool) at week 8 and week 12 Fatigue (Visual Analogue Scale) at week 8 and week 12 |
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Notes | Other outcome measures related to lymphoedema | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Randomisation was conducted by a person not associated with the trial by a computer‐generated random number system. |
Allocation concealment (selection bias) | Low risk | Participants received notification of their group allocation in sealed envelopes after baseline testing. |
Blinding of participants and personnel (performance bias) All outcomes | Unclear risk | No information on blinding of participants and personnel |
Blinding of outcome assessment (detection bias) All outcomes | Low risk | Researchers blinded to group allocation and previous results |
Incomplete outcome data (attrition bias) All outcomes | Low risk | 20% dropout in yoga group, 15% dropout in control group at week 8 |
Selective reporting (reporting bias) | High risk | Results differ compared with study protocol. Quality of life changed from primary to secondary outcome. 4‐week measurements no longer mentioned, not all outcomes reported |
Other bias | High risk | Small sample size; original sample size calculation: 19 participants per group necessary. From Mixed‐Methods Study (Protocol) to Pilot Study |