Chronic Lymphocytic LeukemiaADRENALINENCT06396611
Exercise As Intervention in Chronic Lymphocytic Leukemia
A study testing Exercise Training as Intervention in people with Chronic Lymphocytic Leukemia, run by Universidade do Porto at 1 site in Portugal.
Trial summary
PURPOSE: The purpose of the study is to determine the effects of 16-weeks of exercise training, as measured by aerobic capacity, strength and physical function, and body composition, in patients with Chronic Lymphocytic Leukemia (CLL). DESIGN: Subjects will have confirmed treatment naïve CLL. Read more about this study
- Who is it for?
- Ages 45 to 80 years
- Conditions the study is for
- Chronic Lymphocytic Leukemia
- What is being tested?
- Exercise Training as Intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 11 participants
- Where
- 1 sitePortugal
- Study dates
- 1 Sep 2023to 31 Aug 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 45 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Confirmed diagnosis of CLL as per the International Workshop on CLL Guidelines
- No history of previous treatment of CLL
- Able to walk on a treadmill or cycle ergometer
- Able to carry weights, or use weight machines
- Pass initial evaluations (CPET for cardiac health, Isokinetic for muscular health)
- Willing to adhere to the exercise program
- Signed informed consent
Who cannot join
- Previous CLL treatments
- Ongoing engagement in a regular exercise program
- Indication of disease progression and for starting treatment within 6 months
- Other primary tumour
- Inability to perform exercise (Heart disease, advanced stage respiratory, renal, hepatic, neurological, or osteoarticular disease)
- Unable to travel to FADEUP facilities or comply with other study requirements
Trial locations and contacts
1 site in 1 country.
Portugal1 site
Faculty of Sport of University of Porto
Porto, Porto District, 4200-450
About this study
Official title: Randomised Controlled Clinical Trial of Exercise As Intervention in Chronic Lymphocytic Leukemia
PURPOSE: The purpose of the study is to determine the effects of 16-weeks of exercise training, as measured by aerobic capacity, strength and physical function, and body composition, in patients with Chronic Lymphocytic Leukemia (CLL).
DESIGN: Subjects will have confirmed treatment naïve CLL. Subjects will be assigned to either a 16-week control group (no supervised exercise) or an intervention group of Resistance Training (REx). Before and after the 16-week protocol, patients will undergo several tests including: 1) a maximal cycle ergometer test, 2) Body Composition, 3) Muscle strength, 4) physical activity levels, 5) blood measures (e.g. immune and inflammatory functions).
Read more
DATA ANALYSES \& SAFETY ISSUES: For outcomes, group change differences from baseline to 16-weeks will be compared with ANCOVA. Resistance training is a very safe exercise modality already studied in other cancer patients. The regular use of vigorous-intensity exercise has been used extensively in exercise training. It will always be respected for each subject's safety tolerance while challenging.
HYPOTHESIS: The investigators hypothesize that the protocol will be feasible exercise interventions for people with CLL and will improve health and fitness markers.
Read the detailed description
PURPOSE: The purpose of the study is to determine the effects of 16-weeks of exercise training, as measured by aerobic capacity, strength and physical function, and body composition, in patients with CLL and without any prior treatment.
DESIGN: Subjects will have confirmed treatment naïve CLL. Subjects will be assigned to either a 16-week control group (no supervised exercise) or an intervention group of Resistance Training (REx). Before and after the 16-week protocol, patients will undergo several tests including: 1) a Cardiopulmonary Exercise Test with Electrocardiogram (CPET+ECG) maximal cycle ergometer test, 2) a dual-energy X-ray absorptiometry (DEXA) Body Composition test, 3) a Muscle strength test with dynamometry, 4) a characterization of physical activity (PA) levels with accelerometry, and 5) blood measures (e.g. immune and inflammatory functions). The REx group will undertake a strength-based type of training with intensities near 80% of 1-Repetition Maximum (1-RM), with individual supervision (personal training approach).
DATA ANALYSES \& SAFETY ISSUES: For outcomes, group change differences from baseline to 16-weeks will be compared with ANCOVA. Resistance training is a very safe exercise modality already studied in other cancer patients. The regular use of vigorous-intensity exercise has been used extensively in exercise training. It will always be respected for each subject's safety tolerance while challenging.
HYPOTHESIS: The investigators hypothesize that the protocol will be feasible exercise interventions for people with CLL and will improve health and fitness markers. It is also expected to have a positive correlation between physical fitness improvement and blood and immunologic parameters.
- Conditions
- Chronic Lymphocytic Leukemia
- Being tested
- Exercise Training as Intervention
- Keywords
- Strength Training, Physical Activity, Chronic Lymphocytic Leukemia, Vigorous Physical Activity
- Medical subject headings
- Leukemia, Lymphocytic, Chronic, B-Cell, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Exercise Training as InterventionBehavioural
Supervised Exercise Training as an Intervention using Resistance Training.
| Study group | Role | What they receive |
|---|---|---|
| Resistance Exercise Training | Experimental | Patients in the REx program are submitted to resistance machine exercises for the major muscle groups aiming to achieve the intensity of 80% of 1-Repetition Maximum (1-RM). A warmup and cool down of 10 and 5 minutes, respectively, were included in each session aiming workloads of 60%-85% of peak heart rate (HRp). Enrolment through the REx program resistance machines will be conducted from major muscle groups to minor muscle groups, from polyarticular to monoarticular exercises, and alternating between agonist and antagonist contraction according to the following laydown: Leg Press -> Leg Curl -> Leg Extension -> Chest Press -> Latissimus Pulldown -> Shoulder Press -> Triceps Extension -> Biceps Curl -> Abdominal Crunch. Receives: Behavioral: Exercise Training as Intervention |
| Conventional Care (Control Group) | No intervention | Control group patients received advice to follow their habitual physical activity routines and are contacted bimonthly to ensure participant retention in the study. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in VO2 peak as measured by cardiopulmonary exercise test
Cardio metabolic CPET + Stress ECG
Measured: Baseline to 16-weeks
Change in muscular strength (peak torque and power) as measured by isokinetic dynamometer exercise test
BIODEX Concentric/Concentric Strength Test for Lower Body evaluation
Measured: Baseline to 16-weeks
Change in muscular strength (grip force in kg) as measured by dynamometer exercise test
JAMAR Hand Grip for Upper Body Evaluation
Measured: Baseline to 16-weeks
Change in muscular strength (kg of weight lifted) as measured by 1 repetition maximum exercise test
1 Repetition Maximum For Strength Evaluation of Whole Body
Measured: Baseline to 16-weeks
Change in Whole Body Composition (comprehending grams of total mass, total fat mass, total lean mass and percentage of fat mass)
DEXA Test for Whole Body Composition
Measured: Baseline to 16-weeks
Change in Bone Mineral Density (comprehending Total Femural and Femural Neck bone mineral density)
DEXA Test for Bone Mineral Density
Measured: Baseline to 16-weeks
Secondary outcomes (6)
Change in Health Related Quality of Life as measured by FACIT-F questionnaire
Questionnaire The Functional Assessment of Chronic Illness Therapy - Fatigue (FACIT-F), a 40-item measure that assesses self-reported fatigue.
Measured: Baseline to 16-weeks
Change in Health Related Quality of Life as measured by EORTC QLQ-C30 and CLL17 questionnaires
Questionnaire from EORTC Quality of Life Group (EORTC QLQ-C30) a 30-item instrument designed to measure quality of life in all cancer patients, with the supplement of CLL17 a 17-item instrument designed to measure quality of life in chronic lymphocytic leukemia patients
Measured: Baseline to 16-weeks
Change in Physical Activity patterns as measured by Accelerometry over a period of seven consecutive days
GT9XLink accelerometer from Actigraph to collect data of the Physical Activity patterns, over a period of seven consecutive days, with a minimum of 10 hours of daily assessment
Measured: Baseline to 16-weeks
Change in Blood counts (hemoglobin (g/dL) and platelets (10^9/L)) as measured by Peripheral Blood Collection
Peripheral Blood Collection during Hospital Consultation
Measured: Baseline to 16-weeks
Change in Leukocytes counts (in percentage of lymphocytes, monocytes, neutrophils) as measured by Peripheral Blood Collection
Peripheral Blood Collection during Hospital Consultation
Measured: Baseline to 16-weeks
Change in Minerals counts (comprehending iron (ug/dL), sodium (mEq/L), potassium (mEq/L) and magnesium (mEq/L)) as measured by Peripheral Blood Collection
Peripheral Blood Collection during Hospital Consultation
Measured: Baseline to 16-weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 May 2024
- Study start1 Sep 2023
- Primary completion31 Aug 2025 (estimated)
- Study completion31 Aug 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Lymphocytic LeukemiaStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Model description
- Eligible patients who fulfil criteria will be randomized into a controlled design (RCT) comparing the effects of 16 weeks intervention program with a maximum of 2 sessions per week ensuring a 24h rest period between similar sessions, for the same aims and muscular groups. All participants are assessed in primary and secondary outcome measures before and after the intervention period. The intervention is designed with: a) Resistance Exercise Training (REX); b) Control Group (CG). We also expect to follow up those patients, after the intervention protocol terminus, using routine consultation on participating Hospitals, and acquiring data to support the long-term effects of the protocol. The follow-up will maintain the Onco-Hematology consultations routine and periodicity (6 months after last medical appointment), where all initial assessments will be undertaken.
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 11 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidade do Porto
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Pedro MP Cunha, MSc., Principal investigator, Faculty of Sport of University of Porto
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06396611
- Sponsor's protocol ID
- CLL_FADEUP
- Acronym
- ADRENALINE
- Status last verified
- Feb 2025
- First submitted
- 18 Apr 2024
- Last updated
- 19 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The datasets generated during the present study will not be publicly available, owing to the risk of disclosure or deduction of private individual information, but can be available from the corresponding author on reasonable request.
Study at a glance
From the registry record, last updated by the sponsor on 19 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomised Controlled Clinical Trial of Exercise As Intervention in Chronic Lymphocytic Leukemia
- ClinicalTrials.gov ID
- NCT06396611
- Acronym / sponsor ID
- ADRENALINE / CLL_FADEUP
- Conditions
- Chronic Lymphocytic Leukemia
- Keywords
- Strength Training, Physical Activity, Chronic Lymphocytic Leukemia, Vigorous Physical Activity
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 11 participants (actual)
- Lead sponsor
- Universidade do PortoUniversity, hospital or other
- Study start
- 1 Sep 2023 (actual)
- Primary completion
- 31 Aug 2025 (estimated)
- Study completion
- 31 Aug 2025 (estimated)
- First posted
- 2 May 2024 (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.
PURPOSE: The purpose of the study is to determine the effects of 16-weeks of exercise training, as measured by aerobic capacity, strength and physical function, and body composition, in patients with Chronic Lymphocytic Leukemia (CLL).
DESIGN: Subjects will have confirmed treatment naïve CLL. Subjects will be assigned to either a 16-week control group (no supervised exercise) or an intervention group of Resistance Training (REx). Before and after the 16-week protocol, patients will undergo several tests including: 1) a maximal cycle ergometer test, 2) Body Composition, 3) Muscle strength, 4) physical activity levels, 5) blood measures (e.g. immune and inflammatory functions).
DATA ANALYSES \& SAFETY ISSUES: For outcomes, group change differences from baseline to 16-weeks will be compared with ANCOVA. Resistance training is a very safe exercise modality already studied in other cancer patients. The regular use of vigorous-intensity exercise has been used extensively in exercise training. It will always be respected for each subject's safety tolerance while challenging.
HYPOTHESIS: The investigators hypothesize that the protocol will be feasible exercise interventions for people with CLL and will improve health and fitness markers.
Detailed description
PURPOSE: The purpose of the study is to determine the effects of 16-weeks of exercise training, as measured by aerobic capacity, strength and physical function, and body composition, in patients with CLL and without any prior treatment.
DESIGN: Subjects will have confirmed treatment naïve CLL. Subjects will be assigned to either a 16-week control group (no supervised exercise) or an intervention group of Resistance Training (REx). Before and after the 16-week protocol, patients will undergo several tests including: 1) a Cardiopulmonary Exercise Test with Electrocardiogram (CPET+ECG) maximal cycle ergometer test, 2) a dual-energy X-ray absorptiometry (DEXA) Body Composition test, 3) a Muscle strength test with dynamometry, 4) a characterization of physical activity (PA) levels with accelerometry, and 5) blood measures (e.g. immune and inflammatory functions). The REx group will undertake a strength-based type of training with intensities near 80% of 1-Repetition Maximum (1-RM), with individual supervision (personal training approach).
DATA ANALYSES \& SAFETY ISSUES: For outcomes, group change differences from baseline to 16-weeks will be compared with ANCOVA. Resistance training is a very safe exercise modality already studied in other cancer patients. The regular use of vigorous-intensity exercise has been used extensively in exercise training. It will always be respected for each subject's safety tolerance while challenging.
HYPOTHESIS: The investigators hypothesize that the protocol will be feasible exercise interventions for people with CLL and will improve health and fitness markers. It is also expected to have a positive correlation between physical fitness improvement and blood and immunologic parameters.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
- Model description
- Eligible patients who fulfil criteria will be randomized into a controlled design (RCT) comparing the effects of 16 weeks intervention program with a maximum of 2 sessions per week ensuring a 24h rest period between similar sessions, for the same aims and muscular groups. All participants are assessed in primary and secondary outcome measures before and after the intervention period. The intervention is designed with: a) Resistance Exercise Training (REX); b) Control Group (CG). We also expect to follow up those patients, after the intervention protocol terminus, using routine consultation on participating Hospitals, and acquiring data to support the long-term effects of the protocol. The follow-up will maintain the Onco-Hematology consultations routine and periodicity (6 months after last medical appointment), where all initial assessments will be undertaken.
| Arm | Type | Receives |
|---|---|---|
| Resistance Exercise Training | Experimental | Behavioral: Exercise Training as InterventionPatients in the REx program are submitted to resistance machine exercises for the major muscle groups aiming to achieve the intensity of 80% of 1-Repetition Maximum (1-RM). A warmup and cool down of 10 and 5 minutes, respectively, were included in each session aiming workloads of 60%-85% of peak heart rate (HRp). Enrolment through the REx program resistance machines will be conducted from major muscle groups to minor muscle groups, from polyarticular to monoarticular exercises, and alternating between agonist and antagonist contraction according to the following laydown: Leg Press -> Leg Curl -> Leg Extension -> Chest Press -> Latissimus Pulldown -> Shoulder Press -> Triceps Extension -> Biceps Curl -> Abdominal Crunch. |
| Conventional Care (Control Group) | No intervention | –Control group patients received advice to follow their habitual physical activity routines and are contacted bimonthly to ensure participant retention in the study. |
Who may qualify
- Ages
- 45 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Confirmed diagnosis of CLL as per the International Workshop on CLL Guidelines
- No history of previous treatment of CLL
- Able to walk on a treadmill or cycle ergometer
- Able to carry weights, or use weight machines
- Pass initial evaluations (CPET for cardiac health, Isokinetic for muscular health)
Key exclusion criteria (6 listed)
- Previous CLL treatments
- Ongoing engagement in a regular exercise program
- Indication of disease progression and for starting treatment within 6 months
- Other primary tumour
- Inability to perform exercise (Heart disease, advanced stage respiratory, renal, hepatic, neurological, or osteoarticular disease)
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 |
|---|---|---|
| Exercise Training as InterventionSupervised Exercise Training as an Intervention using Resistance Training. | Behavioural | Resistance Exercise Training |
Primary outcome
Change in VO2 peak as measured by cardiopulmonary exercise test
Time frame: Baseline to 16-weeks
Cardio metabolic CPET + Stress ECG
Change in muscular strength (peak torque and power) as measured by isokinetic dynamometer exercise test
Time frame: Baseline to 16-weeks
BIODEX Concentric/Concentric Strength Test for Lower Body evaluation
Change in muscular strength (grip force in kg) as measured by dynamometer exercise test
Time frame: Baseline to 16-weeks
JAMAR Hand Grip for Upper Body Evaluation
Change in muscular strength (kg of weight lifted) as measured by 1 repetition maximum exercise test
Time frame: Baseline to 16-weeks
1 Repetition Maximum For Strength Evaluation of Whole Body
Change in Whole Body Composition (comprehending grams of total mass, total fat mass, total lean mass and percentage of fat mass)
Time frame: Baseline to 16-weeks
DEXA Test for Whole Body Composition
Change in Bone Mineral Density (comprehending Total Femural and Femural Neck bone mineral density)
Time frame: Baseline to 16-weeks
DEXA Test for Bone Mineral Density
6 secondary outcomes
Change in Health Related Quality of Life as measured by FACIT-F questionnaire
Time frame: Baseline to 16-weeks
Change in Health Related Quality of Life as measured by EORTC QLQ-C30 and CLL17 questionnaires
Time frame: Baseline to 16-weeks
Change in Physical Activity patterns as measured by Accelerometry over a period of seven consecutive days
Time frame: Baseline to 16-weeks
Change in Blood counts (hemoglobin (g/dL) and platelets (10^9/L)) as measured by Peripheral Blood Collection
Time frame: Baseline to 16-weeks
Change in Leukocytes counts (in percentage of lymphocytes, monocytes, neutrophils) as measured by Peripheral Blood Collection
Time frame: Baseline to 16-weeks
Change in Minerals counts (comprehending iron (ug/dL), sodium (mEq/L), potassium (mEq/L) and magnesium (mEq/L)) as measured by Peripheral Blood Collection
Time frame: Baseline to 16-weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Mar 2025.
- Individual participant dataSharing planned: No. The datasets generated during the present study will not be publicly available, owing to the risk of disclosure or deduction of private individual information, but can be available from the corresponding author on reasonable request.
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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.
Pedro MP Cunha, MSc. principal investigator
Faculty of Sport of University of Porto
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Exercise Training as Intervention in people with Chronic Lymphocytic Leukemia, run by Universidade do Porto at 1 site in Portugal.
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 7 inclusion and 6 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: under way, not looking for participants, as of the sponsor's last update on 19 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Portugal. 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?
This study is still under way. Results are not available in the source record yet.
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?
Change in VO2 peak as measured by cardiopulmonary exercise test (time frame: Baseline to 16-weeks). The study lists 6 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 19 Mar 2025.