STAY-STRONG Study of Exercise Training During Chemotherapy

NCT05556239 | Completed DMC

• 1 other identifier: H-22014826
• Study Type: interventional
• Target: 42
• Locations: 1 country
• Sites: 1

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.

Conditions

Lymphoma, B-Cell; Lymphoma, Hodgkin; Exercise; Body Composition; Physical Functional Performance; Quality of Life; Sarcopenia; Muscle, Skeletal; Patient Reported Outcome Measures

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (23)

• Functional performance: Habitual gait speed

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

• Functional performance: Maximal gait speed

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

• Functional performance: Stair climbing power

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

• Functional performance: Sit-to-stand

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

• Muscle strength:Hand grip strength

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

Other Outcomes (5)

• Muscle biopsies

  Baseline, 4-month follow-up

• Muscle Architecture: Muscle Thickness

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

• Muscle Architecture: Pennation Angle

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

Study Arms (2)

The usual care group

NO INTERVENTION

The usual care group receives standard care in accordance to current clinical practice at Rigshospitalet

Resistance Exercise Training

EXPERIMENTAL

Patients included in the intervention group will receive usual care plus the exercise training intervention.

Behavioral: Resistance Exercise Training

Interventions

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.

Resistance Exercise Training

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Rigshospitalet, Denmark: lead

Study Sites (1)

Rigshospitalet

Copenhagen, Denmark

Location

Related Publications (1)

• 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.

  PMID: 39606939 DERIVED

MeSH Terms

Conditions

Lymphoma, B-Cell; Hodgkin Disease; Motor Activity; Sarcopenia

Interventions

Resistance Training

Condition Hierarchy (Ancestors)

Lymphoma, Non-Hodgkin; Lymphoma; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases; Behavior; Muscular Atrophy; Neuromuscular Manifestations; Neurologic Manifestations; Nervous System Diseases; Atrophy; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Exercise Therapy; Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Therapeutics; Physical Therapy Modalities; Physical Conditioning, Human; Exercise; Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Senior researcher

Study Record Dates

• First Submitted: September 22, 2022
• First Posted: September 27, 2022
• Study Start: October 25, 2022
• Primary Completion: October 1, 2024
• Study Completion: May 1, 2025
• Last Updated: December 8, 2025

Record last verified: 2025-12

Locations

DK (1)