Rigshospitalet, Denmark
Jan Christensen
This study evaluates the effectiveness of a supervised progressive resistance training program in patients malignant lymphomas with the primary outcome being lean body mass. The study is designed as a a single center, two-armed, parallel-group, investigator-initiated clinical randomized controlled superiority trail evaluating the effectiveness of a 4-month supervised progressive resistance training intervention compared to usual care.
Lymphoma, B-Cell
Lymphoma, Hodgkin
Exercise
Body Composition
Physical Functional Performance
Quality of Life
Sarcopenia
Muscle, Skeletal
Patient Reported Outcome Measures
Resistance Exercise Training
Not Applicable
New approaches of early rehabilitation are needed to maintain physical function levels in patients with malignant lymphoma patients during chemotherapy treatment. The STAY STRONG TRAIL has the potential to become the future model of care and rehabilitation with the prospect of reducing the complex symptom burden, supporting treatment tolerance, maintaining physical function and, by extension, improve the patient's chances of survival and quality of life. This study will be among the first to include structured and supervised progressive resistance training during the complete 1st line anthracycline-containing combination chemotherapy regime in patients treated with Diffuse Large B-Cell Lymphoma and Hodgkin Lymphoma. At present, there is a lack of knowledge regarding the potential effect of exercise to counteract muscle atrophy during chemotherapy in patients with malignant lymphomas. The overall aim of the present STAY STRONG TRAIL is to investigate whether a structured and supervised progressive resistance training program during the complete first line anthracycline-containing combination chemotherapy with support from an 'exercise ambassador' can preserve muscle function and prevent muscle dysfunction in patients newly diagnosed with Diffuse Large B-Cell Lymphoma and Hodgkin Lymphoma referred to first line treatment.}}
| Study Type : | Interventional |
| Estimated Enrollment : | 42 participants |
| Masking : | Single |
| Primary Purpose : | Treatment |
| Official Title : | The Effect of Resistance Training in Patients With Malignant Lymphoma Undergoing Chemotherapy Treatment - the STAY STRONG TRIAL - a Randomized Controlled Trial. |
| Actual Study Start Date : | October 25, 2022 |
| Estimated Primary Completion Date : | October 1, 2024 |
| Estimated Study Completion Date : | January 1, 2025 |
| Arm | Intervention/treatment |
|---|---|
|
No Intervention: The usual care group The usual care group receives standard care in accordance to current clinical practice at Rigshospitalet |
|
|
Experimental: Resistance Exercise Training Patients included in the intervention group will receive usual care plus the exercise training intervention. |
| Ages Eligible for Study: | 18 Years |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
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Recruiting
Rigshospitalet
Copenhagen, Denmark,