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

Coleman 2012.

Methods Randomisation
  • 2 arms: stretching, aerobics and strength resistance training versus standard care


Recruitment period
  • Not reported


Median follow‐up time
  • No follow‐up analysis


Sample size calculation
  • unclear, various assumptions in the published papers

Participants Eligibility criteria
  • New diagnosis of multiple myeloma

  • Eligible for tandem autologous peripheral‐blood stem cell transplantation

  • No risk for pathologic fractures or spinal cord compression


Participants (N = 187)
  • Intervention group (N = 95)

  • Control group (N = 92)


Mean age
  • Intervention group: 56.0 years

  • Control group: 56.4 years


Stage of disease
  • Not reported


Therapy
  • Intervention group: 69% Total Therapy II, 31% Total Therapy III; 36% no thalidomide, 64% thalidomide

  • Control group: 75% Total Therapy II, 25% Total Therapy III; 43% no thalidomide, 57% thalidomide


Country
  • USA

Interventions Exercise group
  • Aerobic exercise: walking to tolerance (until tired)

  • Stretching: performed daily for various muscles

  • Strength resistance training on alternate days with stretch bands.


Control group
  • Participants advised to follow written exercise recommendations provided by their physician. Advised to remain as active as possible and to try to walk 20 minutes per day

  • All participants received high‐dose therapy and tandem transplantation (Total Therapy II or Total Therapy III). 50% of those receiving Total Therapy II were randomised to receive thalidomide during induction, after transplantation consolidation, and maintenance therapy. All Total Therapy III participants (62) received thalidomide. EPO administered to first 102 study participants (investigational algorithm) that allowed haemoglobin levels to reach 15 g/dL before dose reduction or delay, and started before chemotherapy unless baseline haemoglobin was < 15 g/dL, differing from recommended haemoglobin parameters for EPO administration to participants who are receiving chemotherapy outside of a clinical trial setting.

  • Duration of short‐term study was 15 weeks. The first 70 participants who met eligibility for long‐term participation (i.e. response to EPO) continued in the study for an additional 15 weeks, which included administration of DCEP, melphalan and the first peripheral‐blood stem cell transplantation

  • EPO was administered to the first 102 study participants according to an investigational algorithm that allowed haemoglobin levels to reach 15 g/dL before dose reduction or delay, and started before chemotherapy unless baseline haemoglobin was less than 15 g/dL.

Outcomes Reported and analysed in this review
  • Fatigue

  • 6‐minute walk test

  • Adverse events


Reported but not relevant for this review
  • Response to intensive treatment protocol for multiple myeloma

  • Time to recovery after transplantation

  • Haemoglobin levels

  • Number of red blood cell‐ and platelet transfusions

  • Number of attempts at and total days of stem cell collection

Notes Conflict of interest not reported, funding not reported
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Unclear risk Not reported
Allocation concealment (selection bias) Unclear risk Not reported
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) Unclear risk Not reported
Incomplete outcome data (attrition bias) 
 All outcomes High risk 15 participants who dropped out were not analysed
Selective reporting (reporting bias) Low risk All outcomes mentioned in the protocol are reported
Other bias High risk 50% of participants received thalidomide. In the study analysis this drug administration was not considered and no subgroup data were provided for participants receiving or not receiving thalidomide