LymphomaNCT06660446
Exercise During Chemotherapy Treatment As Adjuvant Program in Patients with Lymphoma: EDONOLA Study.
A study testing Exercise in people with Lymphoma, run by Biogipuzkoa Health Research Institute at 3 sites in Spain.
Trial summary
In people diagnosed with lymphoma receiving immunochemotherapy treatment, a combined exercise intervention, as opposed to the general recommendations, will achieve: 1.Improve cardiorespiratory fitness, strength, psychological well-being and quality of life. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lymphoma
- What is being tested?
- Exercise
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 180 participants
- Where
- 3 sitesSpain
- Study dates
- 8 Oct 2024to 30 Mar 2027
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age: ≥18 years old.
- Diagnosis of lymphoma with histological confirmation and requirement of systemic treatment including chemotherapy.
- Time available (80 minutes, two days a week for 20 weeks) to carry out physical exercise sessions.
- Have a mobile phone to be able to contact the person and download the physical activity level app.
- Eastern Cooperative Oncology Group performance status (ECOG) ≤2.
- Life expectancy \>12 months.
- Availability and desire to participate throughout the study period.
Who cannot join
- Have a contraindication to moderate-high intensity exercise.
- Other significant medical disorders: including psychiatric illnesses chronic or recurrent; intellectual disability, musculoskeletal problems, cardiac or pulmonary disorders that interfere with physical exercise; other malignant tumors in the last five years, with the exception of therapeutically controlled skin cancer; any other illness that may be seen affected or aggravated by physical exercise.
- Have plans to be outside city more than two weeks.
- People who are already physically active (that comply with the recommendations of WHO: \> 150 minutes of exercise moderate/weekly, plus training force two days/week).
- Treatment based only with immunotherapy.
- Central nervous system involvement due to lymphoma.
- Have any important history that limit the capacity of the patient to participate in the study.
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Clinical Research Platform - Health Research Institut Biogipuzkoa contact
Spain3 sites, 2 recruiting
- Active, not recruiting
Hospital Universitario Galdakao (HUG)
Galdakao, Bizkaia, 48960
- Recruiting
Hospital Universitario Donostia (HUD)
San Sebastián, Guipuzcoa, 20014
Clinical Research Platform - Clinical Research Institute Biogipuzkoa, OSID.INVESTCLINICA@osakidetza.eus
- Not yet recruiting
Hospital Universitario Araba (HUA)
Vitoria - Gateiz, Araba, 01009
Clinical Research Platform - Clinical Research Institute Biogipuzkoa, OSID.INVESTCLINICA@osakidetza.eus
About this study
Official title: Ejercicio Físico Durante El Tratamiento De Quimioterapia Como Programa Adyuvante En Pacientes Con Linfoma: Estudio EDONOLA
In people diagnosed with lymphoma receiving immunochemotherapy treatment, a combined exercise intervention, as opposed to the general recommendations, will achieve: 1.Improve cardiorespiratory fitness, strength, psychological well-being and quality of life. //2.Reduce fatigue//3.Reduce frailty
There is an association between some biological biomarkers with physical capacity and frailty.
Read the detailed description
In this study, the effectiveness of an individualized adjuvant exercise program will be analyzed in a homogeneous population of people diagnosed with lymphoma in active treatment. Taking into account the limited scientific evidence that currently exists in people affected by lymphoma and active treatment, the study could be of great relevance when it comes to providing scientific evidence in this very little field studied. The study will try to respond to the evident need to focus the research area on supervised exercise in people with lymphoma in a way innovative, with the aim of generating new hypotheses that overcome existing limitations and facilitate the introduction of this type of interventions into the health system. The present study will also analyze the effect of exercise from a gender perspective, an aspect not systematically studied until now, providing a new vision on the baseline differences and after intervention of a program based on of sex.
The study will include adults with lymphoma with special focus on the subanalysis of the group of patients equal or more than 70 years old. The lymphoma unit of the Donostia University Hospital (HUD) is part of the Onkofrail project that analyzes the impact of a physical activity in older cancer patients. The Onkofrail study has included everything type of solid tumors and very diverse treatments, which is a limitation methodology that could condition the analysis of the results. Therefore, the need of proposing a new exercise project in a homogeneous population such as that of people with lymphoma, the most prevalent hemopathy in our environment, which has a great survival, but present important adverse effects secondary to treatment systemic. 30 people with lymphoma and treatment have been included in the Onkofrail study asset. The preliminary results of said pilot study have been used for the design of this new study, making adaptations, both in the recruitment time, as well as inclusion and exclusion criteria, which guarantee and optimize the correct research development.
Main objective:
The main objective is to assess whether a supervised (2 days/week) combined (resistance+aerobic interval training) exercise intervention, plus 2 days/week unsupervised for 20 weeks improves cardiorespiratory fitness (CRF) in people diagnosed with lymphoma undergoing chemotherapy, compared to a control group receiving only general recommendations.
Secondary objectives:
- To estimate cardiorespiratory capacity (VO2peak) through a field test Modified Shuttle Walking Test (MSWT) and other covariates related to body composition, heart rate, among others. Validation of the predictive model.
- To characterise and define the profile of the population diagnosed with lymphoma at the physical, emotional, and biochemical (biomarker) and immune system level prior to an intervention with exercise.
- To investigate whether the implementation of an exercise programme adjuvant to immunochemotherapy treatment modifies fatigue, adherence (actual dose-intensity), and toxicity related to clinical treatment.
- To analyse whether the intervention with exercise is effective in increasing strength levels, improving quality of life and sleep.
- To clarify whether there are sex differences in the efficacy of the exercise programme adjuvant to immunochemotherapy treatment.
- To analyse the benefit of adding exercise programmes in different subgroups of people with lymphoma, with a special focus on the group of patients aged ≥70 years, with the aim of maximising the cost-effectiveness of implementation in the care routine in all patients.
- To analyse the degree of adherence to the programme: degree of attendance at planned sessions and percentage of participants who complete the post-intervention evaluation.
- To report the degree of satisfaction by people affected by lymphoma, as reported in an interview.
- Conditions
- Lymphoma
- Being tested
- Exercise
- Keywords
- Lymphoma, Physical Exercise, Fatigue, Cardiorespiratory capacity, Life Quality
- Medical subject headings
- Lymphoma, Motor Activity, Fatigue
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ExerciseOther
The lymphoma unit of the Donostia University Hospital (HUD) is part of the Onkofrail project that analyzes the impact of a physical activity in older cancer patients. The Onkofrail study has included everything type of solid tumors and very diverse treatments, which is a limitation methodology that could condition the analysis of the results. Therefore, the need of proposing a new PE project in a homogeneous population such as that of people with lymphoma, the most prevalent hemopathy in our environment, which has a great survival, but present important adverse effects secondary to treatment systemic.
| Study group | Role | What they receive |
|---|---|---|
| Control Group | No intervention | The control group will receive the usual care and indications. |
| Intervention Group | Experimental | The interventional group will add a exercise program. Receives: Other: Exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cardiorespiratory fitness (CRF)
Measured by peak oxygen uptake (VO2peak) before starting chemotherapy treatment and after 20 weeks of intervention, using the cardiorespiratory exercise test.
Measured: 20 weeks
Secondary outcomes (35)
Sociodemographic, etiological and clinical health variables (A)
Recruitment Center (Donostia University Hospital, Galdakao University Hospital , Alava University Hospital)
Measured: 20 weeks
Sociodemographic, etiological and clinical health variables (B)
Birthdate.
Measured: 20 weeks
Sociodemographic, etiological and clinical health variables (C)
Biological sex (man, woman, I prefer not to answer)
Measured: 20 weeks
Sociodemographic, etiological and clinical health variables (D)
Gender (man, woman, non-binary or I prefer not to answer)
Measured: 20 weeks
Sociodemographic, etiological and clinical health variables (E)
Educational level (no studies, elementary, high school, vocational training, university, I prefer not to answer, others)
Measured: 20 weeks
Sociodemographic, etiological and clinical health variables (F)
Home composition (single person, lives with couple, lives with family, institutionalized, I prefer not to answer, others)
Measured: 20 weeks
Functionality and fragility variables at times T0, T1 and T2 (A.1.)
Muscle power and fragility --> SIT - TO STAND (STS) POWER: time to repeat the action 5 (sec)
Measured: 20 weeks
Functionality and fragility variables at times T0, T1 and T2 (A.2.)
Muscle power and fragility --> FRAILTY TRAIT TEST SCALE (FTS-5): BMI (kg/m)2; running time (sec); grip strength (kg); Progressive Romberg Test (positive/negative).
Measured: 20 weeks
Functionality and fragility variables at times T0, T1 and T2 (B.1.)
G8 Scale (0-17 pts)
Measured: 20 weeks
Functionality and fragility variables at times T0, T1 and T2 (B.2.)
Fried Frailty Phenotype (0-5 pts)
Measured: 20 weeks
Functionality and fragility variables at times T0, T1 and T2 (C)
Physical Condition: Modified Shuttle Walking Field Test (meters)
Measured: 20 weeks
Functionality and fragility variables at times T0, T1 and T2 (D)
UPPER BODY MUSCLE STRENGTH (HANGRIP) (Newton)
Measured: 20 weeks
Functionality and fragility variables at times T0, T1 and T2 (E)
Body composition --> Height (cm); Weight (kg); Waist circumference (cm); hip circumference (cm); body mass index (kg/m2); fat free mass (kg and %); fat mass (kg and %); total body water (kg and %); phase angle (º); systolic blood pressure (mmHG); diastolic blood presure (mmHg); resistance (Ω); reactance (Ω).
Measured: 20 weeks
Functionality and fragility variables at times T0, T1 and T2 (F)
Physical activity level --> Global Questionnaire on Physical Activity (GPAQ)
Measured: 20 weeks
Functionality and fragility variables at times T0, T1 and T2 (G)
Sleep Quality --> Epworth Sleepiness Scale (ESS EPWORTH) (0-24 pts)
Measured: 20 weeks
Functionality and fragility variables at times T0, T1 and T2 (H)
Acelerometry (h/d)
Measured: 20 weeks
Patient Reported Results (A)
Quality of Life Questionnaire --> Hematological Malignancy - Patient Reported Outcome (HM-PRO) at times T0, T1 and T2 (Nothing, mild and serious)
Measured: 20 weeks
3. Patient-reported results (PRO):
EORTC QLQ - FA13
Measured: 20 weeks
Biomarkers
Inflammation (pg/ml or ng/ml), Hematological (pg/ml or ng/ml), Endocrine Nutritional (pg/ml or ng/ml), Immunosenescence (pg/ml or ng/ml),
Measured: 20 weeks
Variables of Geriatric Assessment (VGA) comprehensive in patients (A)
Gijon Scale (3-15 pts)
Measured: 20 weeks
Variables of Geriatric Assessment (VGA) comprehensive in patients (B)
Basic Activity of Dialy Living (BADL) - Barthel Scale (0-10 pts)
Measured: 20 weeks
Variables of Geriatric Assessment (VGA) comprehensive in patients (C)
Instrumental Activity of Dialy Livings (IADL) - Lawton Scale (0-8 pts)
Measured: 20 weeks
Variables of Geriatric Assessment (VGA) comprehensive in patients (D)
Cognitive Function - Pfeiffer Test (0-10 pts)
Measured: 20 weeks
Variables of Geriatric Assessment (VGA) comprehensive in patients (E)
Nutritional Status - Mini Nutritional Assessment Short-form (MNA.SFI) (0-14 pts)
Measured: 20 weeks
Variables of Geriatric Assessment (VGA) comprehensive in patients (F)
Polypharmacy (number of chronica drug consumed by the participant)
Measured: 20 weeks
Variables of Geriatric Assessment (VGA) comprehensive in patients (G)
Geriatric Syndromes - Immobility and pressure ulcers (Yes/No); instability and falls (Yes/No); urinary and faecal incontinence (Yes/No); dementia and acute confusional syndrome ( Yes//No); malnutrition (Yes/No); alterations in sight and hearing (Yes/No);constipation, faecal impaction (Yes/No);depression/insomnia (Yes/No)
Measured: 20 weeks
Variables of Geriatric Assessment (VGA) comprehensive in patients (H)
Pain - Visual Analogue Scale (VAS) (0-10 pts)
Measured: 20 weeks
Variables of Geriatric Assessment (VGA) comprehensive in patients (I)
Emotional Distress - Stress Thermometer (0-10 pts)
Measured: 20 weeks
Treatment data and results after the intervention (T2) (A)
Treatment Suspension (Yes/No)
Measured: 20 weeks
Treatment data and results after the intervention (T2) (B)
Dose Reduction (Yes/No)
Measured: 20 weeks
Treatment data and results after the intervention (T2) (C)
Treatment percentage completed (%)
Measured: 20 weeks
Treatment data and results after the intervention (T2) (D)
Treatment Completion (Yes/No)
Measured: 20 weeks
Assessment of the intervention at T2 (A)
Adverse events associated with intervention (Number of adverse events)
Measured: 20 weeks
Assessment of the intervention at T2 (B)
Satisfaction with the intervention (Yes/No)
Measured: 20 weeks
Assessment of the intervention at T2 (C)
Adherence to the intervention (Yes/No)
Measured: 20 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Oct 2024
- Study start8 Oct 2024
- Primary completion30 Mar 2027 (estimated)
- Study completion30 Mar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for LymphomaStudies 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 180 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Biogipuzkoa Health Research Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Izaskun Zeberio Etxetxipia, Principal investigator, Hospital Donostia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06660446
- Sponsor's protocol ID
- EDONOLA
- Status last verified
- Feb 2025
- First submitted
- 7 Oct 2024
- Last updated
- 19 Feb 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ejercicio Físico Durante El Tratamiento De Quimioterapia Como Programa Adyuvante En Pacientes Con Linfoma: Estudio EDONOLA
- ClinicalTrials.gov ID
- NCT06660446
- Acronym / sponsor ID
- EDONOLA
- Conditions
- Lymphoma
- Keywords
- Lymphoma, Physical Exercise, Fatigue, Cardiorespiratory capacity, Life Quality
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 180 participants (estimated)
- Lead sponsor
- Biogipuzkoa Health Research InstituteUniversity, hospital or other
- Study start
- 8 Oct 2024 (actual)
- Primary completion
- 30 Mar 2027 (estimated)
- Study completion
- 30 Mar 2027 (estimated)
- First posted
- 28 Oct 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.
In people diagnosed with lymphoma receiving immunochemotherapy treatment, a combined exercise intervention, as opposed to the general recommendations, will achieve: 1.Improve cardiorespiratory fitness, strength, psychological well-being and quality of life. //2.Reduce fatigue//3.Reduce frailty
There is an association between some biological biomarkers with physical capacity and frailty.
Detailed description
In this study, the effectiveness of an individualized adjuvant exercise program will be analyzed in a homogeneous population of people diagnosed with lymphoma in active treatment. Taking into account the limited scientific evidence that currently exists in people affected by lymphoma and active treatment, the study could be of great relevance when it comes to providing scientific evidence in this very little field studied. The study will try to respond to the evident need to focus the research area on supervised exercise in people with lymphoma in a way innovative, with the aim of generating new hypotheses that overcome existing limitations and facilitate the introduction of this type of interventions into the health system. The present study will also analyze the effect of exercise from a gender perspective, an aspect not systematically studied until now, providing a new vision on the baseline differences and after intervention of a program based on of sex.
The study will include adults with lymphoma with special focus on the subanalysis of the group of patients equal or more than 70 years old. The lymphoma unit of the Donostia University Hospital (HUD) is part of the Onkofrail project that analyzes the impact of a physical activity in older cancer patients. The Onkofrail study has included everything type of solid tumors and very diverse treatments, which is a limitation methodology that could condition the analysis of the results. Therefore, the need of proposing a new exercise project in a homogeneous population such as that of people with lymphoma, the most prevalent hemopathy in our environment, which has a great survival, but present important adverse effects secondary to treatment systemic. 30 people with lymphoma and treatment have been included in the Onkofrail study asset. The preliminary results of said pilot study have been used for the design of this new study, making adaptations, both in the recruitment time, as well as inclusion and exclusion criteria, which guarantee and optimize the correct research development.
Main objective:
The main objective is to assess whether a supervised (2 days/week) combined (resistance+aerobic interval training) exercise intervention, plus 2 days/week unsupervised for 20 weeks improves cardiorespiratory fitness (CRF) in people diagnosed with lymphoma undergoing chemotherapy, compared to a control group receiving only general recommendations.
Secondary objectives:
- To estimate cardiorespiratory capacity (VO2peak) through a field test Modified Shuttle Walking Test (MSWT) and other covariates related to body composition, heart rate, among others. Validation of the predictive model.
- To characterise and define the profile of the population diagnosed with lymphoma at the physical, emotional, and biochemical (biomarker) and immune system level prior to an intervention with exercise.
- To investigate whether the implementation of an exercise programme adjuvant to immunochemotherapy treatment modifies fatigue, adherence (actual dose-intensity), and toxicity related to clinical treatment.
- To analyse whether the intervention with exercise is effective in increasing strength levels, improving quality of life and sleep.
- To clarify whether there are sex differences in the efficacy of the exercise programme adjuvant to immunochemotherapy treatment.
- To analyse the benefit of adding exercise programmes in different subgroups of people with lymphoma, with a special focus on the group of patients aged ≥70 years, with the aim of maximising the cost-effectiveness of implementation in the care routine in all patients.
- To analyse the degree of adherence to the programme: degree of attendance at planned sessions and percentage of participants who complete the post-intervention evaluation.
- To report the degree of satisfaction by people affected by lymphoma, as reported in an interview.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control Group | No intervention | –The control group will receive the usual care and indications. |
| Intervention Group | Experimental | Other: ExerciseThe interventional group will add a exercise program. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Age: ≥18 years old.
- Diagnosis of lymphoma with histological confirmation and requirement of systemic treatment including chemotherapy.
- Time available (80 minutes, two days a week for 20 weeks) to carry out physical exercise sessions.
- Have a mobile phone to be able to contact the person and download the physical activity level app.
- Eastern Cooperative Oncology Group performance status (ECOG) ≤2.
Key exclusion criteria (7 listed)
- Have a contraindication to moderate-high intensity exercise.
- Other significant medical disorders: including psychiatric illnesses chronic or recurrent; intellectual disability, musculoskeletal problems, cardiac or pulmonary disorders that interfere with physical exercise; other malignant tumors in the last five years, with the exception of therapeutically controlled skin cancer; any other illness that may be seen affected or aggravated by physical exercise.
- Have plans to be outside city more than two weeks.
- People who are already physically active (that comply with the recommendations of WHO: \> 150 minutes of exercise moderate/weekly, plus training force two days/week).
- Treatment based only with immunotherapy.
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 |
|---|---|---|
| ExerciseThe lymphoma unit of the Donostia University Hospital (HUD) is part of the Onkofrail project that analyzes the impact of a physical activity in older cancer patients. The Onkofrail study has included everything type of solid tumors and very diverse treatments, which is a limitation methodology that could condition the analysis of the results. Therefore, the need of proposing a new PE project in a homogeneous population such as that of people with lymphoma, the most prevalent hemopathy in our environment, which has a great survival, but present important adverse effects secondary to treatment systemic. | Other | Intervention Group |
Primary outcome
Cardiorespiratory fitness (CRF)
Time frame: 20 weeks
Measured by peak oxygen uptake (VO2peak) before starting chemotherapy treatment and after 20 weeks of intervention, using the cardiorespiratory exercise test.
35 secondary outcomes
Sociodemographic, etiological and clinical health variables (A)
Time frame: 20 weeks
Sociodemographic, etiological and clinical health variables (B)
Time frame: 20 weeks
Sociodemographic, etiological and clinical health variables (C)
Time frame: 20 weeks
Sociodemographic, etiological and clinical health variables (D)
Time frame: 20 weeks
Sociodemographic, etiological and clinical health variables (E)
Time frame: 20 weeks
Sociodemographic, etiological and clinical health variables (F)
Time frame: 20 weeks
Functionality and fragility variables at times T0, T1 and T2 (A.1.)
Time frame: 20 weeks
Functionality and fragility variables at times T0, T1 and T2 (A.2.)
Time frame: 20 weeks
Functionality and fragility variables at times T0, T1 and T2 (B.1.)
Time frame: 20 weeks
Functionality and fragility variables at times T0, T1 and T2 (B.2.)
Time frame: 20 weeks
Functionality and fragility variables at times T0, T1 and T2 (C)
Time frame: 20 weeks
Functionality and fragility variables at times T0, T1 and T2 (D)
Time frame: 20 weeks
Functionality and fragility variables at times T0, T1 and T2 (E)
Time frame: 20 weeks
Functionality and fragility variables at times T0, T1 and T2 (F)
Time frame: 20 weeks
Functionality and fragility variables at times T0, T1 and T2 (G)
Time frame: 20 weeks
Functionality and fragility variables at times T0, T1 and T2 (H)
Time frame: 20 weeks
Patient Reported Results (A)
Time frame: 20 weeks
3. Patient-reported results (PRO):
Time frame: 20 weeks
Biomarkers
Time frame: 20 weeks
Variables of Geriatric Assessment (VGA) comprehensive in patients (A)
Time frame: 20 weeks
Variables of Geriatric Assessment (VGA) comprehensive in patients (B)
Time frame: 20 weeks
Variables of Geriatric Assessment (VGA) comprehensive in patients (C)
Time frame: 20 weeks
Variables of Geriatric Assessment (VGA) comprehensive in patients (D)
Time frame: 20 weeks
Variables of Geriatric Assessment (VGA) comprehensive in patients (E)
Time frame: 20 weeks
Variables of Geriatric Assessment (VGA) comprehensive in patients (F)
Time frame: 20 weeks
Variables of Geriatric Assessment (VGA) comprehensive in patients (G)
Time frame: 20 weeks
Variables of Geriatric Assessment (VGA) comprehensive in patients (H)
Time frame: 20 weeks
Variables of Geriatric Assessment (VGA) comprehensive in patients (I)
Time frame: 20 weeks
Treatment data and results after the intervention (T2) (A)
Time frame: 20 weeks
Treatment data and results after the intervention (T2) (B)
Time frame: 20 weeks
Treatment data and results after the intervention (T2) (C)
Time frame: 20 weeks
Treatment data and results after the intervention (T2) (D)
Time frame: 20 weeks
Assessment of the intervention at T2 (A)
Time frame: 20 weeks
Assessment of the intervention at T2 (B)
Time frame: 20 weeks
Assessment of the intervention at T2 (C)
Time frame: 20 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 Feb 2025.
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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.
Clinical Research Platform - Health Research Institut Biogipuzkoa contact
Izaskun Zeberio Etxetxipia principal investigator
Hospital Donostia
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Exercise in people with Lymphoma, run by Biogipuzkoa Health Research Institute at 3 sites in Spain.
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 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: looking for participants now, as of the sponsor's last update on 19 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Spain. 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?
Contact Clinical Research Platform - Health Research Institut Biogipuzkoa (+34943006140, OSID.INVESTCLINICA@osakidetza.eus), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cardiorespiratory fitness (CRF) (time frame: 20 weeks). 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 Feb 2025.