title: Effects of an 18-week exercise programme started early during breast cancer treatment: a randomised controlled trial.
abstract: BACKGROUND
  Exercise started shortly after breast cancer diagnosis might prevent or diminish fatigue complaints. The Physical Activity during Cancer Treatment (PACT) study was designed to primarily examine the effects of an 18-week exercise intervention, offered in the daily clinical practice setting and starting within 6 weeks after diagnosis, on preventing an increase in fatigue.
  
  
  METHODS
  This multi-centre controlled trial randomly assigned 204 breast cancer patients to usual care (n = 102) or supervised aerobic and resistance exercise (n = 102). By design, all patients received chemotherapy between baseline and 18 weeks. Fatigue (i.e., primary outcome at 18 weeks), quality of life, anxiety, depression, and physical fitness were measured at 18 and 36 weeks.
  
  
  RESULTS
  Intention-to-treat mixed linear model analyses showed that physical fatigue increased significantly less during cancer treatment in the intervention group compared to control (mean between-group differences at 18 weeks: -1.3; 95 % CI -2.5 to -0.1; effect size -0.30). Results for general fatigue were comparable but did not reach statistical significance (-1.0, 95%CI -2.1; 0.1; effect size -0.23). At 18 weeks, submaximal cardiorespiratory fitness and several muscle strength tests (leg extension and flexion) were significantly higher in the intervention group compared to control, whereas peak oxygen uptake did not differ between groups. At 36 weeks these differences were no longer statistically significant. Quality of life outcomes favoured the exercise group but were not significantly different between groups.
  
  
  CONCLUSIONS
  A supervised 18-week exercise programme offered early in routine care during adjuvant breast cancer treatment showed positive effects on physical fatigue, submaximal cardiorespiratory fitness, and muscle strength. Exercise early during treatment of breast cancer can be recommended. At 36 weeks, these effects were no longer statistically significant. This might have been caused by the control participants' high physical activity levels during follow-up.
  
  
  BACKGROUND
  Current Controlled Trials ISRCTN43801571, Dutch Trial Register NTR2138. Trial registered on December 9th, 2009.
authors.affiliation: Julius Center for Health Sciences and Primary Care, University Medical Center Utrecht, PO Box 85500, STR 6.131, 3508 GA, Utrecht, The Netherlands. ntravier@iconcologia.net.|Unit of Nutrition and Cancer, Catalan Institute of Oncology (ICO-IDIBELL), Barcelona, 08907, Spain. ntravier@iconcologia.net.|Department of Clinical Sciences, University of Barcelona, Barcelona, 08907, Spain. ntravier@iconcologia.net.
authors.forename: Noémie
authors.initials: N
authors.lastname: Travier
authors.affiliation: Comprehensive Cancer Organisation (IKNL), PO Box 19079, 3501 DB, Utrecht, The Netherlands. m.velthuis@iknl.nl.
authors.forename: Miranda J
authors.initials: MJ
authors.lastname: Velthuis
authors.affiliation: Julius Center for Health Sciences and Primary Care, University Medical Center Utrecht, PO Box 85500, STR 6.131, 3508 GA, Utrecht, The Netherlands. cnsteinsbisschop@gmail.com.
authors.forename: Charlotte N
authors.initials: CN
authors.lastname: Steins Bisschop
authors.affiliation: Department of Rehabilitation, Nursing Sciences and Sport, University Medical Center Utrecht, Heidelberglaan 100, 3584 CG, Utrecht, The Netherlands. b.j.w.vandenbuijs@umcutrecht.nl.
authors.forename: Bram
authors.initials: B
authors.lastname: van den Buijs
authors.affiliation: Julius Center for Health Sciences and Primary Care, University Medical Center Utrecht, PO Box 85500, STR 6.131, 3508 GA, Utrecht, The Netherlands. e.monninkhof@umcutrecht.nl.
authors.forename: Evelyn M
authors.initials: EM
authors.lastname: Monninkhof
authors.affiliation: Department of Rehabilitation, Nursing Sciences and Sport, University Medical Center Utrecht, Heidelberglaan 100, 3584 CG, Utrecht, The Netherlands. f.j.g.backx@umcutrecht.nl.
authors.forename: Frank
authors.initials: F
authors.lastname: Backx
authors.affiliation: Medical Oncology, St. Antonius Ziekenhuis, Koekoekslaan 1, 3435 CM, Nieuwegein, The Netherlands. m.los@antoniusziekenhuis.nl.
authors.forename: Maartje
authors.initials: M
authors.lastname: Los
authors.affiliation: Internal Medicine - Medical Oncology, Obis Medisch Centrum, Dr vander Hoffplein 1, 6166 BG, Sittard-Geleen, The Netherlands. f.erdkamp@orbisconcern.nl.
authors.forename: Frans
authors.initials: F
authors.lastname: Erdkamp
authors.affiliation: Department of Internal Medicine, Medical Center, Maatweg 3, 3818 TZ, Amersfoort, The Netherlands. h.bloemendal@meandermc.nl.
authors.forename: Haiko J
authors.initials: HJ
authors.lastname: Bloemendal
authors.affiliation: Department of Radiation Oncology, University Medical Center Utrecht, Heidelberglaan 100, 3584 CG, Utrecht, The Netherlands. c.c.rodenhuis@umcutrecht.nl.
authors.forename: Carla
authors.initials: C
authors.lastname: Rodenhuis
authors.affiliation: Department of Surgery, Ziekenhuis Rivierenland, President Kennedylaan 1, 4002 WP, Tiel, The Netherlands. m.de.roos@zrt.nl.
authors.forename: Marnix A J
authors.initials: MA
authors.lastname: de Roos
authors.affiliation: Department of internal medicine, Hofpoort Ziekenhuis, Polanerbaan 2, 3447 GN, Woerden, The Netherlands. mverhaar@zuwehofpoort.nl.
authors.forename: Marlies
authors.initials: M
authors.lastname: Verhaar
authors.affiliation: Internal Medicine, Diakonessenhuis, Bosboomstraat 1, 3582 KE, Utrecht, The Netherlands. dtbokkelhuinink@diakhuis.nl.
authors.forename: Daan
authors.initials: D
authors.lastname: ten Bokkel Huinink
authors.affiliation: Cancer Center, University Medical Center Utrecht, Heidelberglaan 100, 3584 CX, Utrecht, The Netherlands. e.vanderwall@umcutrecht.nl.
authors.forename: Elsken
authors.initials: E
authors.lastname: van der Wall
authors.affiliation: Julius Center for Health Sciences and Primary Care, University Medical Center Utrecht, PO Box 85500, STR 6.131, 3508 GA, Utrecht, The Netherlands. p.h.m.peeters@umcutrecht.nl.
authors.forename: Petra H M
authors.initials: PH
authors.lastname: Peeters
authors.affiliation: Julius Center for Health Sciences and Primary Care, University Medical Center Utrecht, PO Box 85500, STR 6.131, 3508 GA, Utrecht, The Netherlands. a.m.may@umcutrecht.nl.
authors.forename: Anne M
authors.initials: AM
authors.lastname: May
mesh_terms: D000328:Adult; D000368:Aged; D001943:Breast Neoplasms / Q000188:drug therapy / Q000523:psychology* / Q000534:rehabilitation*; D003863:Depression / Q000209:etiology / Q000517:prevention & control; D005081:Exercise Therapy / Q000379:methods*; D005221:Fatigue / Q000517:prevention & control*; D005260:Female; D006801:Humans; D008875:Middle Aged; D053580:Muscle Strength; D010809:Physical Fitness; D011788:Quality of Life