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Lymphoma, B-CellSTAY-STRONGNCT05556239

STAY-STRONG Study of Exercise Training During Chemotherapy

A study testing Resistance Exercise Training in people with Lymphoma, B-Cell and Lymphoma, Hodgkin, run by Copenhagen University Hospital, Rigshospitalet at 1 site in Denmark.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Lymphoma, B-Cell, Lymphoma, Hodgkin, Exercise
What is being tested?
Resistance Exercise Training
Could I receive a placebo?
No, everyone receives an active treatment
How many people
42 participants
Where
1 siteDenmark
Study dates
25 Oct 2022to 1 May 2025
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country.

Denmark1 site

  • Rigshospitalet

    Copenhagen

Other trials in Denmark

About this study

Official 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.

Read the 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.

Being tested
Resistance Exercise Training
Medical subject headings
Lymphoma, B-Cell, Hodgkin Disease, Motor Activity, Sarcopenia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Resistance Exercise TrainingBehavioural

    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.

Study groups in NCT05556239
Study groupRoleWhat they receive
The usual care groupNo interventionThe usual care group receives standard care in accordance to current clinical practice at Rigshospitalet
Resistance Exercise TrainingExperimentalPatients included in the intervention group will receive usual care plus the exercise training intervention.
Receives: Behavioral: Resistance Exercise Training

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Lean Body Mass

    Change in lean body mass. Assessed by whole-body dual-energy x-ray absorptiometry (DXA) scan.

    Measured: Baseline, 4-month follow-up, 8-month follow-up, 1-year follow-up

Secondary outcomes (23)

  1. Functional performance: Habitual gait speed

    Changes in habitual gait speed. Assessed using a 10-Meter walk test

    Measured: Baseline, 4-month follow-up, 8-month follow-up, 1-year follow-up

  2. Functional performance: Maximal gait speed

    Changes in maximal gait speed assessed using a 10-Meter walk test

    Measured: Baseline, 4-month follow-up, 8-month follow-up, 1-year follow-up

  3. Functional performance: Stair climbing power

    Changes in stair climbing power following a fixed protocol.

    Measured: Baseline, 4-month follow-up, 8-month follow-up, 1-year follow-up

  4. Functional performance: Sit-to-stand

    Changes in Sit-to-stand performance is evaluated by the 30-seconds Sit-to-Stand Test (30s STS)

    Measured: Baseline, 4-month follow-up, 8-month follow-up, 1-year follow-up

  5. Muscle strength:Hand grip strength

    Changes in Hand grip strength. Assessed by a dynamometer

    Measured: Baseline, 4-month follow-up, 8-month follow-up, 1-year follow-up

  6. Muscle strength:Maximal isometric knee extensor strength

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

    Measured: Baseline, 4-month follow-up, 8-month follow-up, 1-year follow-up

  7. Leg-extensor power

    Changes in maximum leg power assessed by Nottingham Power Rig

    Measured: Baseline, 4-month follow-up, 8-month follow-up, 1-year follow-up

  8. 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)

    Measured: Baseline, 4-month follow-up, 8-month follow-up, 1-year follow-up

  9. Symptoms burden

    Changes in patient-reported symptoms burden assessed using the in M.D. Anderson Symptom Inventory questionnaire (MDASI)

    Measured: Baseline, 4-month follow-up, 8-month follow-up, 1-year follow-up

  10. Depression and Anxiety.

    Changes in patient-reported depression and anxiety, assessed using the Hospital Anxiety and Depression Scale (HADS).

    Measured: Baseline, 4-month follow-up, 8-month follow-up, 1-year follow-up

  11. 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.

    Measured: Baseline, 4-month follow-up

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

    Changes in blood TNF- α concentration

    Measured: Baseline, 4-month follow-up

  13. Inflammation marker: interleukin (IL)-13

    Changes in blood IL-13 concentration

    Measured: Baseline, 4-month follow-up

  14. Inflammation marker: Interleukin (IL)-6

    Changes in blood IL-6 concentration

    Measured: Baseline, 4-month follow-up

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

    Changes in blood hsCRP concentration

    Measured: Baseline, 4-month follow-up

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

    Changes in blood GDF11 concentration

    Measured: Baseline, 4-month follow-up

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

    Changes in blood GDF15 concentration

    Measured: Baseline, 4-month follow-up

  18. Body composition and anthropometrics: Fat percentage

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

    Measured: Baseline, 4-month follow-up, 8-month follow-up, 1-year follow-up

  19. Body composition and anthropometrics: Body mass

    Changes in body mass

    Measured: Baseline, 4-month follow-up, 8-month follow-up, 1-year follow-up

  20. Body composition and anthropometrics: Total fat mass

    Changes in total fat mass, assessed by DXA

    Measured: Baseline, 4-month follow-up, 8-month follow-up, 1-year follow-up

  21. 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)

    Measured: Baseline, 4-month follow-up, 8-month follow-up, 1-year follow-up

  22. Exercise feasibility: Exercise sessions attendance rate

    Exercise sessions attendance rate (%), defined as number of attended exercise sessions / number of prescribed exercise sessions x 100

    Measured: From baseline to 4-month follow-up

  23. Exercise feasibility: Patient-reported symptomatic adverse events (pain, dizziness, nausea, fatigue, other)

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

    Measured: Immediately before and immediately after each exercise session performed from baseline to 4-month follow-up

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted27 Sep 2022
  2. Study start25 Oct 2022
  3. Primary completion1 Oct 2024
  4. Study completion1 May 2025

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
42 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05556239
Sponsor's protocol ID
H-22014826
Acronym
STAY-STRONG
Status last verified
Dec 2025
First submitted
22 Sep 2022
Last updated
8 Dec 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Ernst M, Wagner C, Oeser A, Messer S, Wender A, Cryns N, Brockelmann PJ, Holtkamp U, Baumann FT, Wiskemann J, Monsef I, Scherer RW, Mishra SI, Skoetz N. Resistance training for fatigue in people with cancer. Cochrane Database Syst Rev. 2024 Nov 28;11(11):CD015518. doi: 10.1002/14651858.CD015518.

    PubMed 39606939

Questions about this trial

What is this clinical trial studying?

A study testing Resistance Exercise Training in people with Lymphoma, B-Cell and Lymphoma, Hodgkin, run by Copenhagen University Hospital, Rigshospitalet at 1 site in Denmark.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 8 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Lean Body Mass (time frame: Baseline, 4-month follow-up, 8-month follow-up, 1-year follow-up). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05556239, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Dec 2025; AzTrials last refreshed its copy on 6 Nov 2026.

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