Quality of Life Clinical Trial
— STAY-STRONGOfficial title:
The Effect of Resistance Training in Patients With Malignant Lymphoma Undergoing Chemotherapy Treatment - the STAY STRONG TRIAL - a Randomized Controlled Trial.
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.
Status | Recruiting |
Enrollment | 42 |
Est. completion date | January 1, 2025 |
Est. primary completion date | October 1, 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - 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. Exclusion Criteria: - 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. |
Country | Name | City | State |
---|---|---|---|
Denmark | Rigshospitalet | Copenhagen |
Lead Sponsor | Collaborator |
---|---|
Rigshospitalet, Denmark |
Denmark,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | 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, | Baseline, 4-month follow-up | |
Other | Muscle Architecture: Muscle Thickness | Changes in muscle thickness will be assessed by ultrasound imaging. | Baseline, 4-month follow-up, 8-month follow-up, 1-year follow-up | |
Other | Muscle Architecture: Pennation Angle | Changes in pennation angle will be assessed by ultrasound imaging. | Baseline, 4-month follow-up, 8-month follow-up, 1-year follow-up | |
Other | Self-reported physical activity | Changes in patient-reported weekly duration of physical activity assessed using The International Physical Activity Questionnaires (I-PAQ, short form) | Baseline | |
Other | Nutrition | Changes in patient-reported nutritional status assessed using The Short Nutritional Assessment Questionnaire (SNAQ) | Baseline, 4-month follow-up, 8-month follow-up, 1-year follow-up | |
Primary | Lean Body Mass | Change in lean body mass. Assessed by whole-body dual-energy x-ray absorptiometry (DXA) scan. | Baseline, 4-month follow-up, 8-month follow-up, 1-year follow-up | |
Secondary | Functional performance: Habitual gait speed | Changes in habitual gait speed. Assessed using a 10-Meter walk test | Baseline, 4-month follow-up, 8-month follow-up, 1-year follow-up | |
Secondary | Functional performance: Maximal gait speed | Changes in maximal gait speed assessed using a 10-Meter walk test | Baseline, 4-month follow-up, 8-month follow-up, 1-year follow-up | |
Secondary | Functional performance: Stair climbing power | Changes in stair climbing power following a fixed protocol. | Baseline, 4-month follow-up, 8-month follow-up, 1-year follow-up | |
Secondary | Functional performance: Sit-to-stand | Changes in Sit-to-stand performance is evaluated by the 30-seconds Sit-to-Stand Test (30s STS) | Baseline, 4-month follow-up, 8-month follow-up, 1-year follow-up | |
Secondary | Muscle strength:Hand grip strength | Changes in Hand grip strength. Assessed by a dynamometer | Baseline, 4-month follow-up, 8-month follow-up, 1-year follow-up | |
Secondary | Muscle strength:Maximal isometric knee extensor strength | Changes in maximal isometric knee extensor strength. Assessed by a dynamometer | Baseline, 4-month follow-up, 8-month follow-up, 1-year follow-up | |
Secondary | Leg-extensor power | Changes in maximum leg power assessed by Nottingham Power Rig | Baseline, 4-month follow-up, 8-month follow-up, 1-year follow-up | |
Secondary | 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) | Baseline, 4-month follow-up, 8-month follow-up, 1-year follow-up | |
Secondary | Symptoms burden | Changes in patient-reported symptoms burden assessed using the in M.D. Anderson Symptom Inventory questionnaire (MDASI) | Baseline, 4-month follow-up, 8-month follow-up, 1-year follow-up | |
Secondary | Depression and Anxiety. | Changes in patient-reported depression and anxiety, assessed using the Hospital Anxiety and Depression Scale (HADS). | Baseline, 4-month follow-up, 8-month follow-up, 1-year follow-up | |
Secondary | 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. | Baseline, 4-month follow-up | |
Secondary | Inflammation marker: Tumor necrosis factor alpha (TNF- a) | Changes in blood TNF- a concentration | Baseline, 4-month follow-up | |
Secondary | Inflammation marker: interleukin (IL)-13 | Changes in blood IL-13 concentration | Baseline, 4-month follow-up | |
Secondary | Inflammation marker: Interleukin (IL)-6 | Changes in blood IL-6 concentration | Baseline, 4-month follow-up | |
Secondary | Inflammation markers: High-sensitivity C-reactive Protein (hsCRP) | Changes in blood hsCRP concentration | Baseline, 4-month follow-up | |
Secondary | Biomarker of muscle atrophy and muscle wasting: Growth differentiation factor 11 (GDF11) | Changes in blood GDF11 concentration | Baseline, 4-month follow-up | |
Secondary | Biomarker of muscle atrophy and muscle wasting: Growth differentiation factor 15 (GDF15) | Changes in blood GDF15 concentration | Baseline, 4-month follow-up | |
Secondary | Body composition and anthropometrics: Fat percentage | Changes in whole-body fat percentage assessed by DXA scan. | Baseline, 4-month follow-up, 8-month follow-up, 1-year follow-up | |
Secondary | Body composition and anthropometrics: Body mass | Changes in body mass | Baseline, 4-month follow-up, 8-month follow-up, 1-year follow-up | |
Secondary | Body composition and anthropometrics: Total fat mass | Changes in total fat mass, assessed by DXA | Baseline, 4-month follow-up, 8-month follow-up, 1-year follow-up | |
Secondary | 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) | Baseline, 4-month follow-up, 8-month follow-up, 1-year follow-up | |
Secondary | Exercise feasibility: Exercise sessions attendance rate | Exercise sessions attendance rate (%), defined as number of attended exercise sessions / number of prescribed exercise sessions x 100 | From baseline to 4-month follow-up | |
Secondary | Exercise feasibility: Patient-reported symptomatic adverse events (pain, dizziness, nausea, fatigue, other) | Changes in 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 |
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