Clinical trial · Interventional
Pre Radiotherapy Daily Exercise Training in Non-Small Cell Lung Cancer
PRIME - Pre Radiotherapy Daily Exercise Training in Non-Small Cell Lung Cancer
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The aim of this study is to evaluate the feasibility and the effect of daily, individual, supervised and structured exercise training before radiotherapy in patients diagnosed with Non-Small Cell Lung Cancer. Primary outcome is maximal oxygen uptake (VO2peak). The hypotheses are that patients who undergo daily exercise training will increase VO2peak, functional capacity (measured by 6-minute walk test (6MWD)) and lung function (forced expired volume in one second (FEV1)).
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Chemoradiation | — | UNRESOLVED | — |
| Non-Small Cell Lung Cancer Stage | Lung Neoplasm | PROBABILISTIC | 0.70 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Control + | Other | — | UNRESOLVED |
| Exercise + | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Exercise + usual care
- description
- The supervised exercise training is carried out on a ergometer cycle as individual daily (mon-fri) training and each exercise training session consists of 20min. The training comprised a warm-up phase followed by 3 exercise phases. Warm-up consisted of 5min light stationary cycling, adjusted to 50-60% of the patients peak power output determine at the incremental cycle test (iPPO). The first exercise phase comprised of 5min interval training consisting of 5x30 sec intervals at 80-95% of the patient's iPPO. Between each interval, there is a 30 sec pause. The 2nd exercise phase consisted of 5min continuous cycling at an intensity equaling 80% of the patient's iPPO. The 3rd exercise phase was similar to the first exercise phase. Intensities increased progressively from the first week to the last week (from 50%, 80% and 70% of iPPO according to the three different phases to 60%, 95% and 80 % of iPPO respectively.
- interventionNames
- Other: Exercise +
- type
- EXPERIMENTAL
- label
- Control - usual care
- description
- The patients randomized to the control group received no training but will be wearing the activity tracker during the intervention.
- interventionNames
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Patients with NSCLC who are treated with concomitant chemo- and radiotherapy. * Age: \> 18 year * WHO performance status 0-1 Exclusion Criteria: * Patients with any symptoms or circumstances that advise against physical activity. * Symptomatic heart disease e.g. arrhythmia or myocardial infarction within the last three months. * Congestive heart failure * Patients who do not read and speak Danish. * Brain or bone metastases; * Prolonged bone marrow suppression * Anti-coagulant treatment * Inability to provide informed consent.
References
Publications (0)
Data not yet available