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. 2019 Jan 31;2019(1):CD009075. doi: 10.1002/14651858.CD009075.pub3

Jarden 2016.

Methods Randomisation
  • 2 arms: 12‐weeks exercises and counselling versus usual care


Recruitment period
  • July 2011 to January 2014


Median follow‐up time
  • 12 weeks


Sample size calculation
  • Reported, sample size 35 participants per arm: quote: "Sample size calculation is based on the primary endpoint; the 6‐minute walk distance (6MWD) and the results from our pilot study"

Participants Eligibility criteria
  • Adults (≥ 18 years of age)

  • Diagnosed with acute leukaemia

  • In complete remission after completing induction treatment

  • Written informed consent


Participants (N = 70)
  • Intervention group (N = 34)

  • Control group (N = 36)


Mean age
  • Intervention group: 54 years (not reported individually)

  • Control group: 54 years (not reported individually)


Stage/type of disease
  • Intervention group: 34 acute leukaemia

  • Control group: 36 acute leukaemia


Country
  • Denmark

Interventions Exercise group
  • All participants received a 12‐week exercise program, 3 times week, 60 to 70 minutes per session

  • Sessions consisted of stationary cycling for 20‐25 minutes, six dynamic resistance exercises using hand weights in 2 sets of 12 repetitions and nutrition support

  • Counseling sessions were conducted at week 0, 6 and 12


Control group
  • Usual care, without any structured or supervised training and without encouragement to do physical exercise

  • Patients were not asked to refrain from physical activity

Outcomes Reported and analysed in this review
  • Physical capacity

  • Functional performance

  • Leisure‐time activity

  • QoL

  • Fatigue

  • Adverse events

Notes Financially supported by The Center for Integrated Rehabilitation of Cancer Patients, The Novo Nordic Foundation, The University Hospitals’ Centre for Health Research (UCSF), The Lundbeck Foundation, The Novo Nordic Foundation for Clinical Nursing Research and The Danish Cancer Society. The authors report no competing interests.
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk Quote: "randomized... using the computerized Clinical Trial Management System"
Allocation concealment (selection bias) Low risk Quote: "A block design with allocation weight of 1:1 will be used to generate treatment allocation"
Blinding of participants and personnel (performance bias) 
 All outcomes High risk Blinding in this context is not feasible
Blinding of outcome assessor (primary endpoint; mortality) Low risk Outcome not reported. The review authors judge that the outcome mortality in this unblinded trial is unlikely to be influenced by lack of blinding
Blinding of outcome assessor (patient‐reported outcomes) High risk Blinding in this context is not feasible
Blinding of outcome assessor (physical performance, AEs, SAEs) Low risk Quote: "however the outcome assessors...be blinded to the participants study allocation"
Incomplete outcome data (attrition bias) 
 All outcomes High risk Out of 70 participants 62 completed study requirements (89%). 8 participants dropped out, 2 from the IG and 6 from the CG
Selective reporting (reporting bias) Low risk All outcomes mentioned in the protocol are reported
Other bias Low risk Financially supported by The Center for Integrated Rehabilitation of Cancer Patients, The Novo Nordic Foundation, The University Hospitals’ Centre for Health Research (UCSF), The Lundbeck Foundation, The Novo Nordic Foundation for Clinical Nursing Research and The Danish Cancer Society. Any bias due to this support is not expected