Effect of physical exercise on cognitive function and brain measures after chemotherapy in patients with breast cancer (PAM study): Protocol of a randomised controlled trial

Lenja Witlox, Sanne B. Schagen, Michiel B. De Ruiter, Mirjam I. Geerlings, Petra H.M. Peeters, Emmie W. Koevoets, Elsken Van Der Wall, Martijn Stuiver, Gabe Sonke, Miranda J. Velthuis, Job A.M.Van Der Palen, Jan J. Jobsen, Anne M. May, E. M. Monninkhof

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Abstract

Introduction After treatment with chemotherapy, many patients with breast cancer experience cognitive problems. While limited interventions are available to improve cognitive functioning, physical exercise showed positive effects in healthy older adults and people with mild cognitive impairment. The Physical Activity and Memory study aims to investigate the effect of physical exercise on cognitive functioning and brain measures in chemotherapy-exposed patients with breast cancer with cognitive problems. Methods and analytics One hundred and eighty patients with breast cancer with cognitive problems 2-4 years after diagnosis are randomised (1:1) into an exercise intervention or a control group. The 6-month exercise intervention consists of twice a week 1-hour aerobic and strength exercises supervised by a physiotherapist and twice a week 1-hour Nordic or power walking. The control group is asked to maintain their habitual activity pattern during 6 months. The primary outcome (verbal learning) is measured at baseline and 6 months. Further measurements include online neuropsychological tests, self-reported cognitive complaints, a 3-tesla brain MRI, patient-reported outcomes (quality of life, fatigue, depression, anxiety, work performance), blood sampling and physical fitness. The MRI scans and blood sampling will be used to gain insight into underlying mechanisms. At 18 months online neuropsychological tests, self-reported cognitive complaints and patient-reported outcomes will be repeated. Ethics and dissemination Study results may impact usual care if physical exercise improves cognitive functioning for breast cancer survivors. Trial registration number NTR6104

Original languageEnglish
Article numbere028117
JournalBMJ open
Volume9
Issue number6
DOIs
Publication statusPublished - 20 Jun 2019

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Cognition
Randomized Controlled Trials
Exercise
Breast Neoplasms
Drug Therapy
Brain
Neuropsychological Tests
Verbal Learning
Control Groups
Physical Fitness
Physical Therapists
MAP protocol
Ethics
Walking
Fatigue
Survivors
Anxiety
Quality of Life
Magnetic Resonance Imaging
Depression

Keywords

  • breast cancer
  • cognitive problems
  • exercise intervention
  • MRI
  • oncology

Cite this

Witlox, L., Schagen, S. B., De Ruiter, M. B., Geerlings, M. I., Peeters, P. H. M., Koevoets, E. W., ... Monninkhof, E. M. (2019). Effect of physical exercise on cognitive function and brain measures after chemotherapy in patients with breast cancer (PAM study): Protocol of a randomised controlled trial. BMJ open, 9(6), [e028117]. https://doi.org/10.1136/bmjopen-2018-028117
Witlox, Lenja ; Schagen, Sanne B. ; De Ruiter, Michiel B. ; Geerlings, Mirjam I. ; Peeters, Petra H.M. ; Koevoets, Emmie W. ; Van Der Wall, Elsken ; Stuiver, Martijn ; Sonke, Gabe ; Velthuis, Miranda J. ; Palen, Job A.M.Van Der ; Jobsen, Jan J. ; May, Anne M. ; Monninkhof, E. M. / Effect of physical exercise on cognitive function and brain measures after chemotherapy in patients with breast cancer (PAM study) : Protocol of a randomised controlled trial. In: BMJ open. 2019 ; Vol. 9, No. 6.
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abstract = "Introduction After treatment with chemotherapy, many patients with breast cancer experience cognitive problems. While limited interventions are available to improve cognitive functioning, physical exercise showed positive effects in healthy older adults and people with mild cognitive impairment. The Physical Activity and Memory study aims to investigate the effect of physical exercise on cognitive functioning and brain measures in chemotherapy-exposed patients with breast cancer with cognitive problems. Methods and analytics One hundred and eighty patients with breast cancer with cognitive problems 2-4 years after diagnosis are randomised (1:1) into an exercise intervention or a control group. The 6-month exercise intervention consists of twice a week 1-hour aerobic and strength exercises supervised by a physiotherapist and twice a week 1-hour Nordic or power walking. The control group is asked to maintain their habitual activity pattern during 6 months. The primary outcome (verbal learning) is measured at baseline and 6 months. Further measurements include online neuropsychological tests, self-reported cognitive complaints, a 3-tesla brain MRI, patient-reported outcomes (quality of life, fatigue, depression, anxiety, work performance), blood sampling and physical fitness. The MRI scans and blood sampling will be used to gain insight into underlying mechanisms. At 18 months online neuropsychological tests, self-reported cognitive complaints and patient-reported outcomes will be repeated. Ethics and dissemination Study results may impact usual care if physical exercise improves cognitive functioning for breast cancer survivors. Trial registration number NTR6104",
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author = "Lenja Witlox and Schagen, {Sanne B.} and {De Ruiter}, {Michiel B.} and Geerlings, {Mirjam I.} and Peeters, {Petra H.M.} and Koevoets, {Emmie W.} and {Van Der Wall}, Elsken and Martijn Stuiver and Gabe Sonke and Velthuis, {Miranda J.} and Palen, {Job A.M.Van Der} and Jobsen, {Jan J.} and May, {Anne M.} and Monninkhof, {E. M.}",
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Witlox, L, Schagen, SB, De Ruiter, MB, Geerlings, MI, Peeters, PHM, Koevoets, EW, Van Der Wall, E, Stuiver, M, Sonke, G, Velthuis, MJ, Palen, JAMVD, Jobsen, JJ, May, AM & Monninkhof, EM 2019, 'Effect of physical exercise on cognitive function and brain measures after chemotherapy in patients with breast cancer (PAM study): Protocol of a randomised controlled trial' BMJ open, vol. 9, no. 6, e028117. https://doi.org/10.1136/bmjopen-2018-028117

Effect of physical exercise on cognitive function and brain measures after chemotherapy in patients with breast cancer (PAM study) : Protocol of a randomised controlled trial. / Witlox, Lenja; Schagen, Sanne B.; De Ruiter, Michiel B.; Geerlings, Mirjam I.; Peeters, Petra H.M.; Koevoets, Emmie W.; Van Der Wall, Elsken; Stuiver, Martijn; Sonke, Gabe; Velthuis, Miranda J.; Palen, Job A.M.Van Der; Jobsen, Jan J.; May, Anne M.; Monninkhof, E. M.

In: BMJ open, Vol. 9, No. 6, e028117, 20.06.2019.

Research output: Contribution to journalArticleAcademicpeer-review

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T1 - Effect of physical exercise on cognitive function and brain measures after chemotherapy in patients with breast cancer (PAM study)

T2 - Protocol of a randomised controlled trial

AU - Witlox, Lenja

AU - Schagen, Sanne B.

AU - De Ruiter, Michiel B.

AU - Geerlings, Mirjam I.

AU - Peeters, Petra H.M.

AU - Koevoets, Emmie W.

AU - Van Der Wall, Elsken

AU - Stuiver, Martijn

AU - Sonke, Gabe

AU - Velthuis, Miranda J.

AU - Palen, Job A.M.Van Der

AU - Jobsen, Jan J.

AU - May, Anne M.

AU - Monninkhof, E. M.

PY - 2019/6/20

Y1 - 2019/6/20

N2 - Introduction After treatment with chemotherapy, many patients with breast cancer experience cognitive problems. While limited interventions are available to improve cognitive functioning, physical exercise showed positive effects in healthy older adults and people with mild cognitive impairment. The Physical Activity and Memory study aims to investigate the effect of physical exercise on cognitive functioning and brain measures in chemotherapy-exposed patients with breast cancer with cognitive problems. Methods and analytics One hundred and eighty patients with breast cancer with cognitive problems 2-4 years after diagnosis are randomised (1:1) into an exercise intervention or a control group. The 6-month exercise intervention consists of twice a week 1-hour aerobic and strength exercises supervised by a physiotherapist and twice a week 1-hour Nordic or power walking. The control group is asked to maintain their habitual activity pattern during 6 months. The primary outcome (verbal learning) is measured at baseline and 6 months. Further measurements include online neuropsychological tests, self-reported cognitive complaints, a 3-tesla brain MRI, patient-reported outcomes (quality of life, fatigue, depression, anxiety, work performance), blood sampling and physical fitness. The MRI scans and blood sampling will be used to gain insight into underlying mechanisms. At 18 months online neuropsychological tests, self-reported cognitive complaints and patient-reported outcomes will be repeated. Ethics and dissemination Study results may impact usual care if physical exercise improves cognitive functioning for breast cancer survivors. Trial registration number NTR6104

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