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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.
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:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Exercise | Other | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Cardiorespiratory fitness (CRF) | Measured by peak oxygen uptake (VO2peak) before starting chemotherapy treatment and after 20 weeks of intervention, using the cardiorespiratory exercise test. | 20 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Sociodemographic, etiological and clinical health variables (A) | Recruitment Center (Donostia University Hospital, Galdakao University Hospital , Alava University Hospital) | 20 weeks |
| Sociodemographic, etiological and clinical health variables (B) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Clinical Research Platform - Health Research Institut Biogipuzkoa | Contact | +34943006140 | OSID.INVESTCLINICA@osakidetza.eus |
| Name | Affiliation | Role |
|---|---|---|
| Izaskun Zeberio Etxetxipia | Hospital Donostia | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital Universitario Araba (HUA) | Not yet recruiting | Vitoria - Gateiz | Araba | 01009 | Spain |
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| ID | Term |
|---|---|
| D008223 | Lymphoma |
| D009043 | Motor Activity |
| D005221 | Fatigue |
| ID | Term |
|---|---|
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
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| ID | Term |
|---|---|
| D015444 | Exercise |
| ID | Term |
|---|---|
| D009043 | Motor Activity |
| D009068 | Movement |
| D009142 | Musculoskeletal Physiological Phenomena |
| D055687 | Musculoskeletal and Neural Physiological Phenomena |
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|
Birthdate.
| 20 weeks |
| Sociodemographic, etiological and clinical health variables (C) | Biological sex (man, woman, I prefer not to answer) | 20 weeks |
| Sociodemographic, etiological and clinical health variables (D) | Gender (man, woman, non-binary or I prefer not to answer) | 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) | 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) | 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) | 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). | 20 weeks |
| Functionality and fragility variables at times T0, T1 and T2 (B.1.) | G8 Scale (0-17 pts) | 20 weeks |
| Functionality and fragility variables at times T0, T1 and T2 (B.2.) | Fried Frailty Phenotype (0-5 pts) | 20 weeks |
| Functionality and fragility variables at times T0, T1 and T2 (C) | Physical Condition: Modified Shuttle Walking Field Test (meters) | 20 weeks |
| Functionality and fragility variables at times T0, T1 and T2 (D) | UPPER BODY MUSCLE STRENGTH (HANGRIP) (Newton) | 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). | 20 weeks |
| Functionality and fragility variables at times T0, T1 and T2 (F) | Physical activity level --> Global Questionnaire on Physical Activity (GPAQ) | 20 weeks |
| Functionality and fragility variables at times T0, T1 and T2 (G) | Sleep Quality --> Epworth Sleepiness Scale (ESS EPWORTH) (0-24 pts) | 20 weeks |
| Functionality and fragility variables at times T0, T1 and T2 (H) | Acelerometry (h/d) | 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) | 20 weeks |
| 3. Patient-reported results (PRO): | EORTC QLQ - FA13 | 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), | 20 weeks |
| Variables of Geriatric Assessment (VGA) comprehensive in patients (A) | Gijon Scale (3-15 pts) | 20 weeks |
| Variables of Geriatric Assessment (VGA) comprehensive in patients (B) | Basic Activity of Dialy Living (BADL) - Barthel Scale (0-10 pts) | 20 weeks |
| Variables of Geriatric Assessment (VGA) comprehensive in patients (C) | Instrumental Activity of Dialy Livings (IADL) - Lawton Scale (0-8 pts) | 20 weeks |
| Variables of Geriatric Assessment (VGA) comprehensive in patients (D) | Cognitive Function - Pfeiffer Test (0-10 pts) | 20 weeks |
| Variables of Geriatric Assessment (VGA) comprehensive in patients (E) | Nutritional Status - Mini Nutritional Assessment Short-form (MNA.SFI) (0-14 pts) | 20 weeks |
| Variables of Geriatric Assessment (VGA) comprehensive in patients (F) | Polypharmacy (number of chronica drug consumed by the participant) | 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) | 20 weeks |
| Variables of Geriatric Assessment (VGA) comprehensive in patients (H) | Pain - Visual Analogue Scale (VAS) (0-10 pts) | 20 weeks |
| Variables of Geriatric Assessment (VGA) comprehensive in patients (I) | Emotional Distress - Stress Thermometer (0-10 pts) | 20 weeks |
| Treatment data and results after the intervention (T2) (A) | Treatment Suspension (Yes/No) | 20 weeks |
| Treatment data and results after the intervention (T2) (B) | Dose Reduction (Yes/No) | 20 weeks |
| Treatment data and results after the intervention (T2) (C) | Treatment percentage completed (%) | 20 weeks |
| Treatment data and results after the intervention (T2) (D) | Treatment Completion (Yes/No) | 20 weeks |
| Assessment of the intervention at T2 (A) | Adverse events associated with intervention (Number of adverse events) | 20 weeks |
| Assessment of the intervention at T2 (B) | Satisfaction with the intervention (Yes/No) | 20 weeks |
| Assessment of the intervention at T2 (C) | Adherence to the intervention (Yes/No) | 20 weeks |
| Hospital Universitario Galdakao (HUG) | Active, not recruiting | Galdakao | Bizkaia | 48960 | Spain |
| Hospital Universitario Donostia (HUD) | Recruiting | San Sebastián | Guipuzcoa | 20014 | Spain |
|
| D006425 | Hemic and Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
| D001519 | Behavior |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |