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

University Hospital Heidelberg

Status: Terminated

Conditions: Cancer, Hematological

Treatments: Behavioral: Experimental: moderate to high-intensity exercise

Study type: Interventional

Funder types: Other

Identifiers

NCT03080792

PRESENT-P/ S-030/2016

Details and patient eligibility

About

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.

Full 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.

Enrollment: 14 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Supportive Care

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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14 participants in 1 patient group

Exercise

Experimental group

Description:

Exercise Intervention, moderate to high-intensity endurance and resistance exercise

Treatment:

Behavioral: Experimental: moderate to high-intensity exercise