Cognition in Allogeneic Stem Cell Transplanted Patients and Sports

NCT02533947 | Unknown

• 2 other identifiers: CaSpoDJCLS R 13/23
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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.

Conditions

Allogeneic Stem Cell Transplantation; Exercise Intervention

Keywords

Allogeneic Stem Cell Transplantation; Hematological Malignancies; Exercise Intervention; Cognitive Function; Fatigue; Randomized Controlled Trial

Outcome Measures

Primary Outcomes (1)

• 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).

  Baseline and 4 months

Secondary Outcomes (13)

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

  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

  Baseline, 4 months, 7 months

• Change in fine-motor function

  Baseline, 4 months, 7 months

• Change in physical fitness (muscle strength)

  Baseline, 4 months, 7 months

• Change in physical ability/capability (walking ability)

  Baseline, 4 months, 7 months

Other Outcomes (5)

• Intentional behaviour related to physical activity

  4 months, 7 months

• Self-efficacy towards physical exercise

  4 months, 7 months

• Situational barriers for physical exercise

  4 months, 7 months

Study Arms (2)

Exercise group

EXPERIMENTAL

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

Behavioral: Exercise

Control group

OTHER

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

Behavioral: Control

Interventions

Exercise BEHAVIORAL

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

Exercise group

Control BEHAVIORAL

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

Control group

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• hematological malignancy (AML, ALL, MDS, OMF, CML, MM, NHL, Hodgkin, AA)
• 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

You may not qualify if:

• \> 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):

Sponsors & Collaborators

• Universitätsklinikum Hamburg-Eppendorf: lead
• Deutsche José Carreras Leukämie-Stiftung (DJCLS): collaborator

Study Sites (1)

University Medical Center Hamburg-Eppendorf

Hamburg, 20246, Germany

RECRUITING

MeSH Terms

Conditions

Hematologic Neoplasms; Fatigue

Interventions

Exercise

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Karl-Heinz Schulz, Prof.Dr.Dr.

  Universitätsklinikum Hamburg-Eppendorf

  PRINCIPAL INVESTIGATOR

Central Study 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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 2, 2015
• First Posted: August 27, 2015
• Study Start: June 1, 2014
• Primary Completion: May 1, 2019
• Study Completion: August 1, 2019
• Last Updated: April 30, 2019

Record last verified: 2019-04

Locations

DE (1)