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Effects of endurance exercise on incidence and severity of cognitive impairments and other therapy-related side effects in leukemia and lymphoma patients undergoing high-dose chemotherapy. A randomized controlled trial.

Effects of endurance exercise on incidence and severity of cognitive impairments and other therapy-related side effects in leukemia and lymphoma patients undergoing high-dose chemotherapy. A randomized controlled trial.

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
DRKS
Registry ID
DRKS00007824
Enrollment
75
Registered
2016-01-26
Start date
2016-05-03
Completion date
Unknown
Last updated
2025-04-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

C92.0 C91.0 C91.8 C83.5 C83.7

Interventions

Group 1: The intervention group recieves a cycle intervention on an ergometer 3x/week for 15-25 minutes at the date of recruiting (during their ca. 4-weeks of highly dosed chemotherapy). The ergometer

Sponsors

Prof. Dr. Wilhelm Bloch Institut für Kreislaufforschung und SportmedizinAbteilung für molekulare und zelluläre SportmedizinDeutsche Sporthochschule Köln
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: - A Diagnosis of an acute leukemia - Approach induction therapy or high dose chemotherapie (for example B-ALL-protocol, GMALL-protocol) or protocols with the therapy aim of a stem cell transplantation (for example DHAP-Induction, S-HAM)

Exclusion criteria

Exclusion criteria: - Age 3, orthopedic illness, cerebral spasm, psychological illness) - A planned surgery - Metastasis of CNS - Other medical reasons not to participate in the study - Cognitive impairment (dementia, MS, apoplex, traumatic brain injury, brain tumor - Lack of willingness for data tob e saved and further processed - outpatient therapy, which does not allow training on a regulare basis

Design outcomes

Primary

MeasureTime frame
The following tests are executed to analyse the cognitive performance at all points of measurment: a) For examining inhibition performance the response inhibition test (INHIB) was applied. The INHIB is a typical task from the Go/No-go paradigm. Therefore the participants are presented to 202 triangle in grey (Go-stimuli) and 48 circle in grey (No-go-stimuli) in a random order on the computer screen and they are instructed to respond as quickly as possible to Go-stimuli by pushing a button on a special keyboard and to show no reaction at all to No-go-stimuli. Every single stimuli will be presented for 200 milliseconds. There is a time lag of one second between the stimuli. For this time, the monitore stays black. The main variable the system counts the number of wrong executions on Go-Stimuli and the mean motor time of these stimuli. This is known as a valid measurement of response inhibiton (see also Royall, Lauterbach, Cummings, Reeve, Rummans, Kaufer et al., 2002). b) Trail-Making-Test Langensteibacher version: The TMT is a test of visuomotor speed (part A) and executive function (part B). In TMT-A, participants are asked to draw a line connection cicled numbers from 1 to 25 as fast and accurately as possible. The score is the time required to connect the circles. TMT-A measures selective attention (see also Daamen & Raab, 2012; Rüsseler, 2010). In TMT-B, participants are asked to draw a line connection ascending, alternating, numbers and letters (1-A-2-B-3-C, etc.). The score is the time required to complete the task. TMT-B measures reactive kognitive flexibility and set shifting (see Daamen & Raab, 2012). If participants cannot complete the task in 300 seconds, the test is terminated. c) The Hopkins Verbal Learning Test --> This procedure examines verbal learning. Participants are presented a list of 12 nouns belonging to three different semantic categories. There are three learning trials and after each participants recall as many words as they remember. 20-

Secondary

MeasureTime frame
Following dependent variable are recordet at t0, t1 and t2: Subjective cognitive performance --> Functional Assessment of Cancer Therapy - Cognitive Function) The quality of life of patients --> EORTC QLQ-C30 questionnaires Psychological stress of patients --> Hospital Anxiety and Depression Scale Patients` fatigue --> Multidimensional Fatigue Inventory - 20 Items questionnaire Level of activity: körperliche Aktivitätsskala Perfromance Status --> Classification of the Eastern Cooperative Oncology Group (ECOG Performance Status) Determination of immune statues and periphere neurotrophic factors of patients --> analyse relevant blood parameters Physical performance of patients --> spiroergometric performance and hand dynamomter Relief of sleep disturbance of the patients --> Pittsburgh sleep quality index Mesurment of acute effects: Color/word interference (Stroop-Test), metal state (MDBF), verbal memory (HVLT-R form 5&6)

Countries

Germany

Contacts

Public ContactFlorian Wolf

Institut für Kreislaufforschung und SportmedizinAbteilung für molekulare und zelluläre SportmedizinDeutsche Sporthochschule Köln

f.wolf@dshs-koeln.de+49-221-4982-5450

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Feb 22, 2026