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

Heim 2007.

Methods Study design: single‐centre quasi‐RCT
Number randomised: 63; 32 to intervention, 31 to control
Study start: not reported; stop date: not reported
Length of intervention: not reported
Length of follow‐up: at 3 months post intervention
Country: Germany
Participants Age, years; n (%):
  • Intervention: 31 to 50 years, 14 (44); 51 to 70 years, 18 (56)

  • Control: 31 to 50 years, 18 (58); 51 to 70 years, 13 (42)


Stage:
  • Intervention: not reported

  • Control: not reported


Inclusion criteria:
• Score ≥ 4 on a linear analogue scale evaluating fatigue, ranging in value from 0 to 10
Exclusion criteria:
• Psychiatric condition
• < 6 weeks since surgery or chemotherapy
Interventions 32 participants assigned to exercise intervention:
  • Educational programme, physical therapy, group exercises (non‐physical activity), and psycho‐oncological interventions

  • Resistance exercises performed for 30 minutes 3 times per week, and aerobic exercises performed 2 times per week for 30 minutes

  • Brochure with instructions for 9 muscle strength and 9 stretching exercises for all large muscle groups, demonstrated by instructor

  • Instructions for aerobic exercises (walking programme), co‐ordination, and relaxation


Adherence:
  • Adherence to muscle strength was 26% at end of rehabilitation and 37% at 3 months after rehabilitation.

  • Adherence to stretching was 30% at end of rehabilitation and 42% at 3 months after rehabilitation.

  • Adherence to aerobic exercises was 163% at end of rehabilitation and 192% at 3 months after rehabilitation.


31 participants assigned to control:
  • Educational programme, physical therapy, group exercises (non‐physical activity), and psycho‐oncological interventions

Outcomes Outcomes:
  • Quality of life assessed via FACT‐G

  • Fatigue assessed via FACT‐F

  • Depression and anxiety assessed via HADS

  • MFI

  • Questionnaire on physical activity and motivation to perform exercises and sport (self‐developed)

  • Cardiopulmonary fitness via Harvard step test

  • Muscular strength with Digimax Multifunktionstest

  • Maximal isometric muscle strength via dynamometer for arm flexors and leg extensors


Numbers of participants assessed:
  • Intervention: baseline, not reported; end of rehabilitation, 32

  • Control: baseline, not reported; end of rehabilitation, 31


Adverse events: not reported
Notes Trial registration link: none available
Trial authors contacted: yes, contacted for means and s for outcomes. However, trial authors did not provide these data.
Intention‐to‐treat analysis: no
Funding: German Fatigue Society
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) High risk “According to their admission to hospital; depending on the alternating weeks they were allocated to the intervention group or the control group”.
Allocation concealment (selection bias) High risk Owing to use of alternating weeks in the randomisation process, allocation was not concealed from investigators.
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 High risk Study personnel and outcome assessors were not masked or blinded to study interventions.
Incomplete outcome data (attrition bias) 
 All outcomes High risk Complete data were available for 59 participants, but no information on missing participants was provided. “More patients in the control group (15) than in the training group (12) did not continue the study”.
Selective reporting (reporting bias) Low risk No selective reporting of outcomes is apparent.
Other bias High risk Study was poorly described, and adherence to resistance exercises was low (42%).