Pre-Exercise for Allogeneic Stem Cell Transplant Patients (PRESENT-P)

Pre-Exercise for Allogeneic Stem Cell Transplant Patients: a Pilot Study

The PRESENT-P study is a one-arm exercise intervention study for hematological cancer patients prior allogeneic stem cell transplantation (allo-HCT). This pilot study will investigate in a prehabilitation approach the safety and feasibility of high-intensity exercise program directly prior transplantation.

Study Overview

• Status: Terminated
• Conditions: Cancer, Hematological
• Intervention / Treatment: Behavioral: Experimental: moderate to high-intensity exercise

Detailed Description

The major objective of PRESENT-P is to investigate the feasibility and safety of a high intensity endurance exercise training (HIIT) and progressive resistance exercise prior allo-HCT. This multicenter pilot study will include n=30 patients. Patients perform two supervised exercise sessions per week. Recruitment take place 6-12 weeks prior allogeneic stem cell transplantation. Further aims of this pilot study are: to estimate the number of eligible patients, evaluate the recruitment procedure, and to explore the effect of HIIT prior allo-HCT on maximal oxygen uptake (VO2peak),submaximal endurance capacity, muscle strength, patient-reported-outcomes including QoL and physical functioning.

• Study Type: Interventional
• Enrollment (Actual): 14
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Germany
  • Cologne, Germany, 50937
    • University of Colone
  • Dresden, Germany, 01307
    • University Hospital Carl Gustav Carus Dresden
  • Frankfurt, Germany, 60488
    • UCT Frankfurt / Hospital North-West
  • Freiburg, Germany, 79106
    • Medical Center - University Freiburg
  • Heidelberg, Germany, 69120
    • Heidelberg University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Hematological cancer, e.g. AML, CLL, MM
• Scheduled for allo-HCT at the University Clinic Heidelberg or other cooperation sites within the next 4-12 weeks
• Patients ≥ 18 years of age
• Sufficient German language skills
• Willing/ able to train at the provided exercise facilities twice per week and to take part in the scheduled testing
• Signed informed consent

Exclusion Criteria:

• Heart insufficiency > NYHA III or uncertain arrhythmia
• Uncontrolled hypertension
• Severe renal dysfunction (GFR < 30%, Creatinine> 3mg/dl)
• Reduced standing or walking ability
• Insufficient hematological capacity (either hemoglobin value below 8 g/dl or thrombocytes below 30.000/µL)
• Any other comorbidities that preclude participation in the exercise programs
• Engaging in systematic intense exercise training (at least 1h twice per week)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: SUPPORTIVE_CARE
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Exercise; Exercise Intervention, moderate to high-intensity endurance and resistance exercise	Behavioral: Experimental: moderate to high-intensity exercise; 2x per week endurance exercise (continuous moderate and high intensity intervall training on a cycle ergometer) and progressive resistance training (machine based hypertrophy training)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Feasibility of supervised high-intensity aerobic exercise training and high-intensity resistance training prior allo-HCT in hematological cancer patients. Measured as adherence to the training protocol	Adherence is defined as >50% of prescribed exercise sessions completed.	4-12 weeks
Safety of supervised high-intensity exercise aerobic exercise training and high-intensity resistance training prior allo-HCT in hematological cancer	Minor and Major adverse events that are related to the exercise intervention	4-12 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in maximal oxygen uptake (VO2peak), assessed in a maximal incremental exercise test (CPET) on a cycle ergometer		4-12 weeks
Change in submaximal endurance performance, assessed in a 6-minute walk test (6MWT)		4-12 weeks
Change in maximal voluntary isometric contraction (MVIC) in a stationary dynamometer test		4-12 weeks
Change in maximal voluntary isometric hand-grip strength		4-12 weeks
Change in Quality of Life (QoL)	European Research and Treatment in Cancer Quality of Life Questionnaire (EORTC QLQ-C30)	4-12 weeks
Change in Fatigue	Multidimensional Fatigue Inventory, MFI 20	4-12 weeks
Change in depression	Center for Epidemiologic Studies Depression Scale, CES-D	4-12 weeks
Body Composition	Bioelectrical impendance analysis	4-12 weeks
Estimate the number of eligible patients		12 month
Evaluation of recruitment procedures	Description of possible recruiting procedures in the ambulatory and stationary setting.	12 month

Collaborators and Investigators

• Sponsor: University Hospital Heidelberg
• Collaborators: University of Cologne; University Hospital Freiburg; University Hospital Dresden
• Investigators: Principal Investigator: Joachim Wiskemann, Dr., Heidelberg University Hospital, National Center for Tumor Disease, Division of Medical Oncology, Working Group Exercise Oncology

Study record dates

Study Major Dates

• Study Start (ACTUAL): November 1, 2016
• Primary Completion (ACTUAL): December 1, 2018
• Study Completion (ACTUAL): June 1, 2019

Study Registration Dates

• First Submitted: December 16, 2016
• First Submitted That Met QC Criteria: March 9, 2017
• First Posted (ACTUAL): March 15, 2017

Study Record Updates

• Last Update Posted (ACTUAL): June 4, 2021
• Last Update Submitted That Met QC Criteria: June 1, 2021
• Last Verified: June 1, 2021

More Information

Terms related to this study

• Keywords: exercise; cancer; stem cell transplantation; high intensity interval training; resistance training; physical fitness
• Other Study ID Numbers: PRESENT-P/ S-030/2016

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO