Cancer, HematologicalPRESENT-PNCT03080792
Pre-Exercise for Allogeneic Stem Cell Transplant Patients
A study testing Experimental: moderate to high-intensity exercise in people with Cancer, Hematological, run by University Hospital Heidelberg at 5 sites in Germany.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cancer, Hematological
- What is being tested?
- Experimental: moderate to high-intensity exercise
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 14 participants
- Where
- 5 sitesGermany
- Study dates
- Nov 2016to Jun 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
5 sites in 1 country.
5 sites in 1 country
Germany5 sites
University of Colone
Cologne, 50937
University Hospital Carl Gustav Carus Dresden
Dresden, 01307
UCT Frankfurt / Hospital North-West
Frankfurt, 60488
Medical Center - University Freiburg
Freiburg im Breisgau, 79106
Heidelberg University Hospital
Heidelberg, 69120
About this study
Official title: 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.
Read the 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.
- Conditions
- Cancer, Hematological
- Being tested
- Experimental: moderate to high-intensity exercise
- Keywords
- stem cell transplantation, exercise, high intensity interval training, resistance training, physical fitness, cancer
- Medical subject headings
- Neoplasms, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Experimental: moderate to high-intensity exerciseBehavioural
2x per week endurance exercise (continuous moderate and high intensity intervall training on a cycle ergometer) and progressive resistance training (machine based hypertrophy training)
| Study group | Role | What they receive |
|---|---|---|
| Exercise | Experimental | Exercise Intervention, moderate to high-intensity endurance and resistance exercise Receives: Behavioral: Experimental: moderate to high-intensity exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
Measured: 4-12 weeks
Secondary outcomes (10)
Change in maximal oxygen uptake (VO2peak), assessed in a maximal incremental exercise test (CPET) on a cycle ergometer
Measured: 4-12 weeks
Change in submaximal endurance performance, assessed in a 6-minute walk test (6MWT)
Measured: 4-12 weeks
Change in maximal voluntary isometric contraction (MVIC) in a stationary dynamometer test
Measured: 4-12 weeks
Change in maximal voluntary isometric hand-grip strength
Measured: 4-12 weeks
Change in Quality of Life (QoL)
European Research and Treatment in Cancer Quality of Life Questionnaire (EORTC QLQ-C30)
Measured: 4-12 weeks
Change in Fatigue
Multidimensional Fatigue Inventory, MFI 20
Measured: 4-12 weeks
Change in depression
Center for Epidemiologic Studies Depression Scale, CES-D
Measured: 4-12 weeks
Body Composition
Bioelectrical impendance analysis
Measured: 4-12 weeks
Estimate the number of eligible patients
Measured: 12 month
Evaluation of recruitment procedures
Description of possible recruiting procedures in the ambulatory and stationary setting.
Measured: 12 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Mar 2017
- Study startNov 2016
- Primary completionDec 2018
- Study completionJun 2019
Why it stopped: Recruitment difficult
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cancer, HematologicalStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 14 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital Heidelberg
- Sponsor type
- University, hospital or other
- Collaborators
- University Hospital Freiburg, University of Cologne, University Hospital Dresden
- Responsible party
- Principal investigator, Joachim Wiskemann, University Hospital Heidelberg
- Investigators
- Joachim Wiskemann, Dr., Principal investigator, Heidelberg University Hospital, National Center for Tumor Disease, Division of Medical Oncology, Working Group Exercise Oncology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03080792
- Sponsor's protocol ID
- PRESENT-P/ S-030/2016
- Acronym
- PRESENT-P
- Status last verified
- Jun 2021
- First submitted
- 16 Dec 2016
- Last updated
- 4 Jun 2021
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pre-Exercise for Allogeneic Stem Cell Transplant Patients: a Pilot Study
- ClinicalTrials.gov ID
- NCT03080792
- Acronym / sponsor ID
- PRESENT-P / PRESENT-P/ S-030/2016
- Conditions
- Cancer, Hematological
- Keywords
- stem cell transplantation, exercise, high intensity interval training, resistance training, physical fitness, cancer
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Recruitment difficult
- Enrolment
- 14 participants (actual)
- Lead sponsor
- University Hospital HeidelbergUniversity, hospital or other
- Collaborators
- University Hospital Freiburg, University of Cologne, University Hospital Dresden
- Study start
- Nov 2016 (actual)
- Primary completion
- Dec 2018 (actual)
- Study completion
- Jun 2019 (actual)
- First posted
- 15 Mar 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Exercise | Experimental | Behavioral: Experimental: moderate to high-intensity exerciseExercise Intervention, moderate to high-intensity endurance and resistance exercise |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (7 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Experimental: moderate to high-intensity exercise2x per week endurance exercise (continuous moderate and high intensity intervall training on a cycle ergometer) and progressive resistance training (machine based hypertrophy training) | Behavioural | Exercise |
Primary outcome
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
Time frame: 4-12 weeks
Adherence is defined as >50% of prescribed exercise sessions completed.
Safety of supervised high-intensity exercise aerobic exercise training and high-intensity resistance training prior allo-HCT in hematological cancer
Time frame: 4-12 weeks
Minor and Major adverse events that are related to the exercise intervention
10 secondary outcomes
Change in maximal oxygen uptake (VO2peak), assessed in a maximal incremental exercise test (CPET) on a cycle ergometer
Time frame: 4-12 weeks
Change in submaximal endurance performance, assessed in a 6-minute walk test (6MWT)
Time frame: 4-12 weeks
Change in maximal voluntary isometric contraction (MVIC) in a stationary dynamometer test
Time frame: 4-12 weeks
Change in maximal voluntary isometric hand-grip strength
Time frame: 4-12 weeks
Change in Quality of Life (QoL)
Time frame: 4-12 weeks
Change in Fatigue
Time frame: 4-12 weeks
Change in depression
Time frame: 4-12 weeks
Body Composition
Time frame: 4-12 weeks
Estimate the number of eligible patients
Time frame: 12 month
Evaluation of recruitment procedures
Time frame: 12 month
Results and safety
The study was stopped early (reason given: Recruitment difficult). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jun 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Joachim Wiskemann, Dr. principal investigator
Heidelberg University Hospital, National Center for Tumor Disease, Division of Medical Oncology, Working Group Exercise Oncology
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Experimental: moderate to high-intensity exercise in people with Cancer, Hematological, run by University Hospital Heidelberg at 5 sites in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 4 Jun 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Recruitment difficult). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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 (time frame: 4-12 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Jun 2021.