STAY-STRONG Study of Exercise Training During Chemotherapy
- Conditions
- ExerciseSarcopeniaLymphoma, B-CellMuscle, SkeletalLymphoma, HodgkinBody CompositionPatient Reported Outcome MeasuresQuality of LifePhysical Functional Performance
- Interventions
- Behavioral: Resistance Exercise Training
- Registration Number
- NCT05556239
- Lead Sponsor
- Rigshospitalet, Denmark
- Brief Summary
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.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 42
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Participants must:
- Be newly diagnosed with diffuse large B-cell lymphoma and Hodgkin Lymphoma
- Be expected to receive treatment with an anthracycline-containing combination chemotherapy at the Department of Hematology, Rigshospitalet
- Be ≥ 18 years of age at the time of signing the informed consent form.
- Be residing in Denmark
- Have an Eastern Cooperative Oncology Group (ECOG) performance status score ≤ 2
- Be able to speak and read Danish, and to provide a signed informed consent form.
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Patients with:
- Clinically significant cardiovascular disease, including, but not limited to: Heart failure NYHA (New York Heart Association) class III-IV, uncontrolled hypertension, and symptomatic cardiac arrhythmias.
- Psychiatric, neurological, or geographical conditions that could influence protocol adherence.
- Disorders that cause an inability to perform exercise training for one hour.
- Any other known malignancy requiring active treatment.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Resistance Exercise Training Resistance Exercise Training Patients included in the intervention group will receive usual care plus the exercise training intervention.
- Primary Outcome Measures
Name Time Method Lean Body Mass Baseline, 4-month follow-up, 8-month follow-up, 1-year follow-up Change in lean body mass. Assessed by whole-body dual-energy x-ray absorptiometry (DXA) scan.
- Secondary Outcome Measures
Name Time Method Functional performance: Stair climbing power Baseline, 4-month follow-up, 8-month follow-up, 1-year follow-up Changes in stair climbing power following a fixed protocol.
Muscle strength:Maximal isometric knee extensor strength Baseline, 4-month follow-up, 8-month follow-up, 1-year follow-up Changes in maximal isometric knee extensor strength. Assessed by a dynamometer
Inflammation marker: Interleukin (IL)-6 Baseline, 4-month follow-up Changes in blood IL-6 concentration
Inflammation markers: High-sensitivity C-reactive Protein (hsCRP) Baseline, 4-month follow-up Changes in blood hsCRP concentration
Biomarker of muscle atrophy and muscle wasting: Growth differentiation factor 15 (GDF15) Baseline, 4-month follow-up Changes in blood GDF15 concentration
Body composition and anthropometrics: Total fat mass Baseline, 4-month follow-up, 8-month follow-up, 1-year follow-up Changes in total fat mass, assessed by DXA
Functional performance: Maximal gait speed Baseline, 4-month follow-up, 8-month follow-up, 1-year follow-up Changes in maximal gait speed assessed using a 10-Meter walk test
Functional performance: Habitual gait speed Baseline, 4-month follow-up, 8-month follow-up, 1-year follow-up Changes in habitual gait speed. Assessed using a 10-Meter walk test
Muscle strength:Hand grip strength Baseline, 4-month follow-up, 8-month follow-up, 1-year follow-up Changes in Hand grip strength. Assessed by a dynamometer
Inflammation marker: Tumor necrosis factor alpha (TNF- α) Baseline, 4-month follow-up Changes in blood TNF- α concentration
Biomarker of muscle atrophy and muscle wasting: Growth differentiation factor 11 (GDF11) Baseline, 4-month follow-up Changes in blood GDF11 concentration
Body composition and anthropometrics: Body mass index (BMI) Baseline, 4-month follow-up, 8-month follow-up, 1-year follow-up 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)
Depression and Anxiety. Baseline, 4-month follow-up, 8-month follow-up, 1-year follow-up Changes in patient-reported depression and anxiety, assessed using the Hospital Anxiety and Depression Scale (HADS).
Exercise feasibility: Exercise sessions attendance rate From baseline to 4-month follow-up Exercise sessions attendance rate (%), defined as number of attended exercise sessions / number of prescribed exercise sessions x 100
Functional performance: Sit-to-stand Baseline, 4-month follow-up, 8-month follow-up, 1-year follow-up Changes in Sit-to-stand performance is evaluated by the 30-seconds Sit-to-Stand Test (30s STS)
Leg-extensor power Baseline, 4-month follow-up, 8-month follow-up, 1-year follow-up Changes in maximum leg power assessed by Nottingham Power Rig
Health Related Quality of Life Baseline, 4-month follow-up, 8-month follow-up, 1-year follow-up 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)
Symptoms burden Baseline, 4-month follow-up, 8-month follow-up, 1-year follow-up Changes in patient-reported symptoms burden assessed using the in M.D. Anderson Symptom Inventory questionnaire (MDASI)
Leisure time physical activity Baseline, 4-month follow-up 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.
Inflammation marker: interleukin (IL)-13 Baseline, 4-month follow-up Changes in blood IL-13 concentration
Body composition and anthropometrics: Fat percentage Baseline, 4-month follow-up, 8-month follow-up, 1-year follow-up Changes in whole-body fat percentage assessed by DXA scan.
Body composition and anthropometrics: Body mass Baseline, 4-month follow-up, 8-month follow-up, 1-year follow-up Changes in body mass
Exercise feasibility: Patient-reported symptomatic adverse events (pain, dizziness, nausea, fatigue, other) Immediately before and immediately after each exercise session performed from baseline to 4-month follow-up Changes in patient-reported symptomatic adverse events (pain, dizziness, nausea, fatigue, other)
Trial Locations
- Locations (1)
Rigshospitalet
🇩🇰Copenhagen, Denmark