Cognition in Allogeneic Stem Cell Transplanted Patients and Sports

NCT ID: NCT02533947

Last Updated: 2019-04-30

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 80 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-06-30
• Study Completion Date: 2019-08-31

Brief Summary

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.

Detailed Description

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.

Conditions

Allogeneic Stem Cell Transplantation; Exercise Intervention

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

Exercise group

The exercise program will be developed through a pilot phase with 10 patients prior to the start of the main study.

Group Type: EXPERIMENTAL

Exercise

Intervention Type: BEHAVIORAL

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

Control group

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

Group Type: OTHER

Control

Intervention Type: BEHAVIORAL

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

Interventions

Exercise

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

Intervention Type: BEHAVIORAL

Control

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

Intervention Type: BEHAVIORAL

Eligibility Criteria

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

• ≥ 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 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):

• > 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Deutsche José Carreras Leukämie-Stiftung (DJCLS)

UNKNOWN

Sponsor Role: collaborator

Universitätsklinikum Hamburg-Eppendorf

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Karl-Heinz Schulz, Prof.Dr.Dr.

Role: PRINCIPAL_INVESTIGATOR

Universitätsklinikum Hamburg-Eppendorf

Locations

University Medical Center Hamburg-Eppendorf

Hamburg, , Germany

Site Status: RECRUITING

Countries

Germany

Central Contacts

Angela Scherwath, Dr. phil.

Role: CONTACT

a.scherwath@uke.de

+49(40) 7410- 57565

Karl-Heinz Schulz, Prof.Dr.Dr.

Role: CONTACT

khschulz@uke.de

+49(40) 7410- 54132

Facility Contacts

Angela Scherwath, Dr. phil.

Role: primary

a.scherwath@uke.de

+49(40) 7410- 57565

Karl-Heinz Schulz, Prof.Dr.Dr.

Role: backup

khschulz@uke.de

+49(40) 7410- 54132

Other Identifiers

DJCLS R 13/23

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

CaSpo

Identifier Type: -

Identifier Source: org_study_id