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| Name | Class |
|---|---|
| Uppsala University | OTHER |
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This study aims to compare the effects of aerobic exercise with or without addition of resistance exercise to usual care in individuals treated with anthracyclines for lymphomas and to compare exercise effects to age- and sex-matched individuals with no prior history of malignant diseases.
In this study, a comparison of the exercise effects between individuals previously treated for specific lymphoma diagnoses and individuals with no history of cancer will be conducted. Therefore, in addition to a randomized controlled trial in individuals with a previous lymphoma diagnosis (i.e., exercise groups and a non-exercising control group), a reference group comprising age- and sex-matched individuals with no history of a cancer diagnosis will also be included. Participants in the reference group will undergo the same exercise intervention as the aerobic exercise group. This study recruits through invitation only.
The primary endpoint in this study is the change in cardiorespiratory fitness, assessed as VO2peak. Secondary endpoints include common risk factors for cardiovascular disease and cardiometabolic health, other variables derived from the cardiopulmonary exercise test and lung function assessments, and muscle cellular endpoints from muscle biopsies obtained from m. vastus lateralis, in addition to patient-reported outcomes.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Aerobic Exercise | Experimental | Aerobic Exercise twice weekly for 5 months. |
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| Combined Aerobic and Resistance Exercise | Experimental | Combined Aerobic and Resistance Exercise twice weekly for 5 months. |
|
| Standard Care | No Intervention | Standard Care, i.e no exercise intervention. | |
| Reference Aerobic Exercise | Active Comparator | Aerobic Exercise twice weekly for 5 months. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Aerobic Exercise | Behavioral | Participants receive twice weekly supervised aerobic treadmill-based exercise sessions for five months. Session duration varies from 20 to 60 minutes, including warm-up, with exercise intensity ranging from 60 to 95% of peak heart rate. Maximal exercise capacity (VO2peak and peak heart rate) will be determined by the CPET performed by certified exercise physiologists at baseline.The exercise prescription will be sequenced so that the exercise intensity and -duration of each exercise varies within each week, leading to an accumulative increase in weekly exercise volume throughout the intervention. This intervention is also given to the Active Comparator group (i.e. non-cancer reference group) |
| Measure | Description | Time Frame |
|---|---|---|
| VO2peak | Peak oxygen uptake during a treadmill-based cardiopulmonary exercise test | Baseline, five months from baseline (i.e. end of intervention) and 2 years from baseline |
| Measure | Description | Time Frame |
|---|---|---|
| Systolic- and diastolic heart chamber dimensions | Cardiac morphology and function will be assessed by echocardiography (2D and 3D echocardiography and 2D strain echocardiography) | Baseline, five months from baseline (i.e. end of intervention) and 2 years from baseline |
| Systolic- and diastolic longitudinal strain |
| Measure | Description | Time Frame |
|---|---|---|
| Muscle genome-wide DNA methylation and gene expression | Will be assessed in Norway only. For a sub-group of participants, muscle biopsies will be further processed for RNA and DNA | Baseline, five months from baseline (i.e. end of intervention) |
| Adverse events |
Inclusion Criteria Lymphoma participants:
Inclusion Criteria Lymphoma participants and non-cancer reference group:
Exclusion Criteria Lymphoma participants:
Exclusion Criteria Lymphoma participants and non-cancer reference group:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Tormod S. Nilsen, PhD | Contact | 95069857 | 0047 | tormodsn@nih.no |
| Helena Igelström, PhD | Contact | 729999599 | 0046 | helena.igelstrom@neuro.uu.se |
| Name | Affiliation | Role |
|---|---|---|
| Tormod S. Nilsen, PhD | Norwegian School of Sport Sciences | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Norweigan School of Sport Sciences | Not yet recruiting | Oslo | Norway |
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| ID | Term |
|---|---|
| D008223 | Lymphoma |
| D009043 | Motor Activity |
| D066126 | Cardiotoxicity |
| D002318 | Cardiovascular Diseases |
| 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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| Combined Aerobic and Resistance Exercise | Behavioral | Twice weekly, supervised combined aerobic and resistance exercise sessions will be offered to participants. Participants randomized to the combined aerobic and resistance training group will follow the same aerobic exercise prescription as described for the Aerobic Exercise arm. In addition, participants in this group will perform five resistance exercises after the aerobic sessions. The resistance exercises will be leg press, knee extension, and calf rise, followed by seated row and chest press. Following familiarization, the training load will progressively increase following a linear periodization model throughout the intervention. exercise prescription will be sequenced so that the exercise intensity and -duration of each exercise varies within each week, leading to an accumulative increase in weekly exercise volume throughout the intervention. Only Lymphoma participants can be randomized to this arm. |
|
Cardiac morphology and function will be assessed by echocardiography (2D and 3D echocardiography and 2D strain echocardiography) |
| Baseline, five months from baseline (i.e. end of intervention) and 2 years from baseline |
| Lean body mass | Body composition will be assessed by dual x-ray absorptiometry | Baseline, five months from baseline (i.e. end of intervention) and 2 years from baseline |
| Fat mass | Body composition will be assessed by dual x-ray absorptiometry | Baseline, five months from baseline (i.e. end of intervention) and 2 years from baseline |
| Forced Vital Capacity | Lung function are assessed with spirometry. | Baseline, five months from baseline (i.e. end of intervention) and 2 years from baseline |
| Forced Expiratory Volume 1 sec | Lung function are assessed with spirometry. | Baseline, five months from baseline (i.e. end of intervention) and 2 years from baseline |
| Maximal voluntary ventilation | Lung function are assessed with spirometry. | Baseline, five months from baseline (i.e. end of intervention) and 2 years from baseline |
| Diffusion capacity | Diffusion capacity for carbon monoxide is assessed with single breath diffusion capacity test. | Baseline, five months from baseline (i.e. end of intervention) and 2 years from baseline |
| Physical activity | Actigraph accelerometer with physical activity diary. 7 days consecutive measurement at each timepoints. | Baseline, five months from baseline (i.e. end of intervention) and 2 years from baseline |
| Physical activity | Patient reported physical activity is assessed with Godin Leisure-Time Exercise Questionnaire | Baseline, 10-12 weeks from baseline, five months from baseline (i.e. end of intervention) and 2 years from baseline |
| Global Health related Quality of life | Patient reported health related quality of life will be assessed with EORTC QLQ C 30 | Baseline, five months from baseline (i.e. end of intervention) and 2 years from baseline |
| Blood volume | Will be assessed in Norway only. Using the carbon monoxide rebreathing method. | Baseline, five months from baseline (i.e. end of intervention) and 2 years from baseline |
| Muscle fiber area | Will be assessed in Norway only. Change in muscle morphology will be assessed in muscle biopsies using immunohistochemistry | Baseline, five months from baseline (i.e. end of intervention) |
| Muscle fiber type | Will be assessed in Norway only. Change in muscle morphology will be assessed in muscle biopsies using immunohistochemistry | Baseline, five months from baseline (i.e. end of intervention) |
| Muscle mitochondria mass | Will be assessed in Norway only. Change in mitochondrial proteins will be assessed in muscle biopsies using western blot | Baseline, five months from baseline (i.e. end of intervention) |
Medical records and Patient reported outcome version of the Common Terminology Criteria for Adverse Events. |
| Five months from baseline (i.e. end of intervention) |
| Helena Igelström | Recruiting | Uppsala | Sweden |
|
| D006425 | Hemic and Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
| D001519 | Behavior |
| D006331 | Heart Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D064420 | Drug-Related Side Effects and Adverse Reactions |
| D064419 | Chemically-Induced Disorders |
| D011832 | Radiation Injuries |
| D014947 | Wounds and Injuries |