NCT02533947 - Cognition in Allogeneic Stem Cell Transplanted Patients and Sports | Crick

Overview

Studies suggest that patients with hematological malignancies undergoing allogeneic hematopoietic stem cell transplantation (HSCT) are at risk for cognitive decline and long-term cognitive dysfunction. To address this issue, a randomized controlled intervention trial on the effect of physical exercise on cognition is conducted. In addition, the impact on psychological and physical health outcomes is evaluated. Results may benefit patients who suffer from disease- or treatment-associated cognitive change.

Studies suggest that patients with hematological malignancies undergoing allogeneic hematopoietic stem cell transplantation (HSCT) are at risk for cognitive decline and long-term cognitive dysfunction. To address this issue, a randomized controlled intervention trial on the effect of physical exercise on cognition is conducted. In addition, the impact on psychological and physical health outcomes such as depression, fatigue, health-related quality of life and physical fitness is evaluated. A healthy control group matched to the patients on age, gender, and education will be included to both control for practice effects on neuropsychological measures and allow additional comparisons on self-report measures. The healthy control group will undergo neuropsychological testing and questionnaire survey at baseline and 4 months. Demographic data will be collected from all study participants at baseline. Medical data will be collected from patients at all time points. Results may benefit patients who suffer from disease- or treatment-associated cognitive change.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

NONE

Enrollment

80

Conditions

Allogeneic Stem Cell Transplantation Exercise Intervention

Interventions

ExerciseBEHAVIORAL

The intervention consists of an individually tailored supervised exercise program with aerobic, strength and coordinative components.

ControlBEHAVIORAL

A waitlist control group will get the intervention after 7 month of treatment as usual.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 75 YearsHealthy volunteers:

Medical Language ↔ Plain English

Patients: Inclusion Criteria: * hematological malignancy (AML, ALL, MDS, OMF, CML, MM, NHL, Hodgkin, AA) * 3 to 6 months after allogeneic HSCT * ≥ 18 years of age at time of transplantation * German as mother tongue * regular follow-up visits at the transplantation center during the first year after transplantation Exclusion Criteria: * \> 75 years of age at time of transplantation * relapse/progress * thrombocyte count ≤ 50 G/l * GvHD with lung involvement * compromised lung function (patients who need oxygen) * compromised cardiovascular function (\< 10-m walk) * florid infection * immobility * neurological disease * severe psychiatric disease * regular intake of psychoactive drugs or substance abuse * uncontrolled diabetes * high fracture risk * impaired vision and/or hearing Healthy controls (matched for age, gender, and education): Inclusion Criteria: * ≥ 18 years of age at time of enrolment * German as mother tongue * residence in the area of the transplantation center or family members/friends accompanying the patients to clinical follow-up visits Exclusion Criteria: * \> 75 years of age at time of enrolment * hematological malignancy * solid tumour disease * neurological disease * severe psychiatric disease * regular intake of psychoactive drugs or substance abuse * impaired vision and/or hearing

Locations (1)

University Medical Center Hamburg-Eppendorf

Hamburg, Germany

RECRUITING

Outcomes

Primary Outcomes

Change in cognitive functioning as assessed by Change in total z-score

Change in total z-score derived from a neuropsychological test battery (TMT-A, TMT-B, subtests Alertness, Sustained Attention and Flexibility from the German TAP, German Version of the Rey Auditory Verbal Learning Test, Digit Span from the WAIS-IV, German Version of the COWA, Tower of London).

Time frame: Baseline and 4 months

Secondary Outcomes

Change in cognitive functioning as assessed by Change in total z-score

Change in total z-score derived from a neuropsychological test battery (TMT-A, TMT-B, subtests Alertness, Sustained Attention and Flexibility from the German TAP, German Version of the Rey Auditory Verbal Learning Test, Digit Span from the WAIS-IV, German Version of the COWA, Tower of London).

Time frame: Baseline and 7 months

Change in self-reported cognitive functioning as assessed by Change in scale sum score (composite score) of the FEDA and FLei questionnaires

Change in scale sum score of the FEDA and FLei questionnaires measuring self-perceived attentional (FEDA scale 1: Distractibility and Retardation in Mental Processes, FEDA scale 2: Fatigue and Retardation in Activities of Daily Living, FEDA scale 3: Decrease in Drive), memory (FLei scale memory), and executive dysfunctions (FLei scale executive function).

Time frame: Baseline, 4 months, 7 months

Change in fine-motor function

Change in z-score derived from the GPT dominant hand

Time frame: Baseline, 4 months, 7 months

Change in physical fitness (muscle strength)

Measured with M. quadriceps isometric strength test, one 10-sec trial on each leg (change in mean strength value)

Time frame: Baseline, 4 months, 7 months

Central Contacts

Angela Scherwath, Dr. phil.

CONTACT

+49(40) 7410- 57565 a.scherwath@uke.de

Karl-Heinz Schulz, Prof.Dr.Dr.

CONTACT

+49(40) 7410- 54132 khschulz@uke.de