An interventional study of Resistance Exercise Training in Lymphoma, B-Cell, Lymphoma, Hodgkin and Exercise, sponsored by Rigshospitalet, Denmark. Completed at 1 site in Denmark. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-12-08.
Sponsored by Rigshospitalet, Denmark · Not applicable, Interventional, and Treatment
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.
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.
1,411 studies on the registry are indexed under Lymphoma, B-Cell; 329 are open to participants now.
This study's enrollment of 42 is above the median of 36 across 1,218 interventional studies indexed under Lymphoma, B-Cell.
Browse Lymphoma, B-Cell studies →Rigshospitalet, Denmark is the lead sponsor of 1,017 studies on the registry; 183 are open to participants now.
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Participants must:
Exclusion Criteria:
Patients with:
The usual care group receives standard care in accordance to current clinical practice at Rigshospitalet
Patients included in the intervention group will receive usual care plus the exercise training intervention.
Behavioral: Resistance Exercise Training
Supervised resistance training program planned as 3 sessions per week of approximately 60 minutes. The resistance training program comprises 6 exercises for the major muscle groups, starting at 2 sets of 15 repetitions maximum progressing to 4 sets of 8 repetitions maximum. Each session will be supervised by physiotherapist to ensure proper technique, and progression in training load. The participants will choose an exercise ambassador from their network, who during the period will be encouraged to, on a weekly basis, to be in contact with the participant.
Lean Body Mass
Change in lean body mass. Assessed by whole-body dual-energy x-ray absorptiometry (DXA) scan.
Time frame: Baseline, 4-month follow-up, 8-month follow-up, 1-year follow-up
Functional performance: Habitual gait speed
Changes in habitual gait speed. Assessed using a 10-Meter walk test
Time frame: Baseline, 4-month follow-up, 8-month follow-up, 1-year follow-up
Functional performance: Maximal gait speed
Changes in maximal gait speed assessed using a 10-Meter walk test
Time frame: Baseline, 4-month follow-up, 8-month follow-up, 1-year follow-up
Functional performance: Stair climbing power
Changes in stair climbing power following a fixed protocol.
Time frame: Baseline, 4-month follow-up, 8-month follow-up, 1-year follow-up
Functional performance: Sit-to-stand
Changes in Sit-to-stand performance is evaluated by the 30-seconds Sit-to-Stand Test (30s STS)
Time frame: Baseline, 4-month follow-up, 8-month follow-up, 1-year follow-up
Muscle strength:Hand grip strength
Changes in Hand grip strength. Assessed by a dynamometer
Time frame: Baseline, 4-month follow-up, 8-month follow-up, 1-year follow-up
Muscle strength:Maximal isometric knee extensor strength
Changes in maximal isometric knee extensor strength. Assessed by a dynamometer
Time frame: Baseline, 4-month follow-up, 8-month follow-up, 1-year follow-up
Leg-extensor power
Changes in maximum leg power assessed by Nottingham Power Rig
Time frame: Baseline, 4-month follow-up, 8-month follow-up, 1-year follow-up
Health Related Quality of Life
Changes in patient-reported health-related quality of life assessed using the European Organization for Research and Treatment of Cancer Quality of Life Core Questionnaire EORTC (EORTC-QLQ-C30)
Time frame: Baseline, 4-month follow-up, 8-month follow-up, 1-year follow-up
Symptoms burden
Changes in patient-reported symptoms burden assessed using the in M.D. Anderson Symptom Inventory questionnaire (MDASI)
Time frame: Baseline, 4-month follow-up, 8-month follow-up, 1-year follow-up
Depression and Anxiety.
Changes in patient-reported depression and anxiety, assessed using the Hospital Anxiety and Depression Scale (HADS).
Time frame: Baseline, 4-month follow-up, 8-month follow-up, 1-year follow-up
Leisure time physical activity
Changes in leisure time physical activity. Assessed by activity accelerometer (ActiGraph wGT3x-BT). Participants will be instructed to wear the accelerometer at their waist for 24 h during ten consecutive days.
Time frame: Baseline, 4-month follow-up
Inflammation marker: Tumor necrosis factor alpha (TNF- α)
Changes in blood TNF- α concentration
Time frame: Baseline, 4-month follow-up
Inflammation marker: interleukin (IL)-13
Changes in blood IL-13 concentration
Time frame: Baseline, 4-month follow-up
Inflammation marker: Interleukin (IL)-6
Changes in blood IL-6 concentration
Time frame: Baseline, 4-month follow-up
Inflammation markers: High-sensitivity C-reactive Protein (hsCRP)
Changes in blood hsCRP concentration
Time frame: Baseline, 4-month follow-up
Biomarker of muscle atrophy and muscle wasting: Growth differentiation factor 11 (GDF11)
Changes in blood GDF11 concentration
Time frame: Baseline, 4-month follow-up
Biomarker of muscle atrophy and muscle wasting: Growth differentiation factor 15 (GDF15)
Changes in blood GDF15 concentration
Time frame: Baseline, 4-month follow-up
Body composition and anthropometrics: Fat percentage
Changes in whole-body fat percentage assessed by DXA scan.
Time frame: Baseline, 4-month follow-up, 8-month follow-up, 1-year follow-up
Body composition and anthropometrics: Body mass
Changes in body mass
Time frame: Baseline, 4-month follow-up, 8-month follow-up, 1-year follow-up
Body composition and anthropometrics: Total fat mass
Changes in total fat mass, assessed by DXA
Time frame: Baseline, 4-month follow-up, 8-month follow-up, 1-year follow-up
Body composition and anthropometrics: Body mass index (BMI)
Changes in BMI. Weight will be measured by scale (kg). Height will be measured by measuring (m). BMI will be derived from weight and height (kg/m\^2)
Time frame: Baseline, 4-month follow-up, 8-month follow-up, 1-year follow-up
Exercise feasibility: Exercise sessions attendance rate
Exercise sessions attendance rate (%), defined as number of attended exercise sessions / number of prescribed exercise sessions x 100
Time frame: From baseline to 4-month follow-up
Exercise feasibility: Patient-reported symptomatic adverse events (pain, dizziness, nausea, fatigue, other)
Changes in patient-reported symptomatic adverse events (pain, dizziness, nausea, fatigue, other)
Time frame: Immediately before and immediately after each exercise session performed from baseline to 4-month follow-up
Muscle biopsies
Muscle biopsies will be taken on a selected number of subjects from the vastus lateralis muscle, for the use in future analysis of i.e. muscle fibre size and distribution, myogenic stem cell activity,
Time frame: Baseline, 4-month follow-up
Muscle Architecture: Muscle Thickness
Changes in muscle thickness will be assessed by ultrasound imaging.
Time frame: Baseline, 4-month follow-up, 8-month follow-up, 1-year follow-up
Muscle Architecture: Pennation Angle
Changes in pennation angle will be assessed by ultrasound imaging.
Time frame: Baseline, 4-month follow-up, 8-month follow-up, 1-year follow-up
Self-reported physical activity
Changes in patient-reported weekly duration of physical activity assessed using The International Physical Activity Questionnaires (I-PAQ, short form)
Time frame: Baseline
Nutrition
Changes in patient-reported nutritional status assessed using The Short Nutritional Assessment Questionnaire (SNAQ)
Time frame: Baseline, 4-month follow-up, 8-month follow-up, 1-year follow-up
This study is completed, as verified in Dec 2025. You cannot join it, but the record below documents what was studied.
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Rigshospitalet, Denmark