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Completed

NCT Number: NCT05556239

STAY-STRONG Study of Exercise Training During Chemotherapy

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.

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Key information

Conditions

Lymphoma, B-Cell Atrophy Behavior Body Composition Exercise Hemic and Lymphatic Diseases Hodgkin Disease Immune System Diseases Immunoproliferative Disorders Lymphatic Diseases Lymphoma Lymphoma, Hodgkin Lymphoma, Non-Hodgkin Lymphoproliferative Disorders Motor Activity Muscle, Skeletal Muscular Atrophy Neoplasms Neoplasms by Histologic Type Nervous System Diseases Neurologic Manifestations Neuromuscular Manifestations Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms Patient Reported Outcome Measures Physical Functional Performance Quality of Life Sarcopenia Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Rigshospitalet

Copenhagen, Denmark

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Resistance Exercise Training

Behavioral

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.

Primary outcomes

  1. Lean Body Mass

    Time frame: 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 outcomes

  1. Functional performance: Habitual gait speed

    Time frame: 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

  2. Functional performance: Maximal gait speed

    Time frame: 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

  3. Functional performance: Stair climbing power

    Time frame: Baseline, 4-month follow-up, 8-month follow-up, 1-year follow-up

    Changes in stair climbing power following a fixed protocol.

  4. Functional performance: Sit-to-stand

    Time frame: 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)

  5. Muscle strength:Hand grip strength

    Time frame: Baseline, 4-month follow-up, 8-month follow-up, 1-year follow-up

    Changes in Hand grip strength. Assessed by a dynamometer

  6. Muscle strength:Maximal isometric knee extensor strength

    Time frame: Baseline, 4-month follow-up, 8-month follow-up, 1-year follow-up

    Changes in maximal isometric knee extensor strength. Assessed by a dynamometer

  7. Leg-extensor power

    Time frame: Baseline, 4-month follow-up, 8-month follow-up, 1-year follow-up

    Changes in maximum leg power assessed by Nottingham Power Rig

  8. Health Related Quality of Life

    Time frame: 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)

  9. Symptoms burden

    Time frame: 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)

  10. Depression and Anxiety.

    Time frame: 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).

  11. Leisure time physical activity

    Time frame: 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.

  12. Inflammation marker: Tumor necrosis factor alpha (TNF- α)

    Time frame: Baseline, 4-month follow-up

    Changes in blood TNF- α concentration

  13. Inflammation marker: interleukin (IL)-13

    Time frame: Baseline, 4-month follow-up

    Changes in blood IL-13 concentration

  14. Inflammation marker: Interleukin (IL)-6

    Time frame: Baseline, 4-month follow-up

    Changes in blood IL-6 concentration

  15. Inflammation markers: High-sensitivity C-reactive Protein (hsCRP)

    Time frame: Baseline, 4-month follow-up

    Changes in blood hsCRP concentration

  16. Biomarker of muscle atrophy and muscle wasting: Growth differentiation factor 11 (GDF11)

    Time frame: Baseline, 4-month follow-up

    Changes in blood GDF11 concentration

  17. Biomarker of muscle atrophy and muscle wasting: Growth differentiation factor 15 (GDF15)

    Time frame: Baseline, 4-month follow-up

    Changes in blood GDF15 concentration

  18. Body composition and anthropometrics: Fat percentage

    Time frame: Baseline, 4-month follow-up, 8-month follow-up, 1-year follow-up

    Changes in whole-body fat percentage assessed by DXA scan.

  19. Body composition and anthropometrics: Body mass

    Time frame: Baseline, 4-month follow-up, 8-month follow-up, 1-year follow-up

    Changes in body mass

  20. Body composition and anthropometrics: Total fat mass

    Time frame: Baseline, 4-month follow-up, 8-month follow-up, 1-year follow-up

    Changes in total fat mass, assessed by DXA

  21. Body composition and anthropometrics: Body mass index (BMI)

    Time frame: 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)

  22. Exercise feasibility: Exercise sessions attendance rate

    Time frame: 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

  23. Exercise feasibility: 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

    Changes in patient-reported symptomatic adverse events (pain, dizziness, nausea, fatigue, other)

Other outcomes

  1. Muscle biopsies

    Time frame: Baseline, 4-month follow-up

    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,

  2. Muscle Architecture: Muscle Thickness

    Time frame: Baseline, 4-month follow-up, 8-month follow-up, 1-year follow-up

    Changes in muscle thickness will be assessed by ultrasound imaging.

  3. Muscle Architecture: Pennation Angle

    Time frame: Baseline, 4-month follow-up, 8-month follow-up, 1-year follow-up

    Changes in pennation angle will be assessed by ultrasound imaging.

  4. Self-reported physical activity

    Time frame: Baseline

    Changes in patient-reported weekly duration of physical activity assessed using The International Physical Activity Questionnaires (I-PAQ, short form)

  5. Nutrition

    Time frame: Baseline, 4-month follow-up, 8-month follow-up, 1-year follow-up

    Changes in patient-reported nutritional status assessed using The Short Nutritional Assessment Questionnaire (SNAQ)

Sponsors and collaborators

Lead sponsor

Rigshospitalet, Denmark

Other

Registry information

Official study title

The Effect of Resistance Training in Patients With Malignant Lymphoma Undergoing Chemotherapy Treatment - the STAY STRONG TRIAL - a Randomized Controlled Trial.

Acronym: STAY-STRONG

Important dates

Study start
2022
Primary completion
2024
Study completion
2025
First posted
Sep 27, 2022
Registry last updated
Dec 8, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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