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Not yet recruitingNCT07479407PREHABUpdated Mar 18, 2026

Effect of Pre-operative Exercise Training on Cardiorespiratory Fitness in Patients With Locally Advanced Non-small Cell Lung Cancer Undergoing Induction Chemo-immunotherapy Followed by Surgery - a Randomized Controlled Study

An interventional study of Preoperative Exercise Training in Locally Advanced Non-small Cell Lung Cancer (NSCLC), sponsored by Hôpital du Valais. Not yet recruiting at 3 sites in Switzerland. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-03-18.

Sponsored by Hôpital du Valais · Not applicable, Interventional, and Prevention

Phase
Not applicable
Study type
Interventional
Enrollment
74
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-12

Among 186 studies in Carcinoma, Non-Small-Cell Lung with a site in Switzerland — 42 open to participants now, 67 under way, 33 of them phase 3. Carcinoma, Non-Small-Cell Lung · Switzerland.

Planned enrollment
126th of 173
74 · median 290
Started
2026
with 7 others
No phase
6 of 186
4 open now
Primary completion
2029-03
later than 44 of 66 live
Registered
184th of 186
by date

Among the 186 studies in Carcinoma, Non-Small-Cell Lung with a site in Switzerland, this one is the 126th largest by planned enrollment of the 173 interventional ones that give a count, is one of 8 that started in 2026, is one of 6 with no phase, reaches primary completion later than 44 of the 66 other live ones, and was the 184th registered.

Carcinoma, Non-Small-Cell Lung

7,620 studies on the registry are indexed under Carcinoma, Non-Small-Cell Lung; 1,838 are open to participants now.

Browse Carcinoma, Non-Small-Cell Lung studies →

Open to participants now

42 of the 186 studies in Carcinoma, Non-Small-Cell Lung with a site in Switzerland are open now. Recruiting first, the newest first:

37 more — sign in →

All 42 open studies →

A study can be open while its sites in Switzerland have not opened yet or have stopped. Only those recruiting at a site in Switzerland →

Who these studies take

Of the 1,324 Carcinoma, Non-Small-Cell Lung studies recruiting now, 986 (74%) set no upper age limit and 226 (17%) stop at 75 or younger; 34 take children under 18; 39 take healthy volunteers.

This study: 18 Years and older · all sexes · no healthy volunteers.

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02

Study summary

The PREHAB study focuses on patients with locally advanced non-small cell lung cancer (NSCLC) undergoing neoadjuvant chemotherapy and/or immunotherapy prior to surgical resection. These systemic treatments frequently impair patients' physiological reserve, reduce physical fitness, and may occasionally lead to cancellation of surgery. Surgery itself carries a substantial risk of cardiorespiratory complications and long-term functional decline.

The primary objective of this study is to determine whether a supervised exercise program, initiated concomitantly with systemic therapy and continued until surgery, can improve cardiorespiratory fitness, surgical tolerance, and postoperative outcomes.

A total of 74 patients will be randomly assigned to one of two groups: an "intervention" group participating in three weekly sessions of supervised endurance and resistance training for 12 to 16 weeks under the guidance of a physiotherapist, and a "control" group receiving usual care without a structured exercise program.

The primary endpoint will be peak oxygen uptake (VO₂peak). Secondary outcomes will include postoperative complication rates, length of hospital stay, pulmonary function, skeletal muscle mass, and quality of life.

Intervention-related risks, primarily falls or overexertion, will be mitigated through professional supervision. This multicenter study, with recruitment scheduled to begin in 2026, is expected to provide robust evidence regarding the effectiveness of targeted exercise training in improving preoperative fitness and postoperative recovery in patients with locally advanced NSCLC.

Read the detailed description

The PREHAB study is a prospective, multicenter, randomized controlled trial designed to evaluate the efficacy of a structured, supervised prehabilitation program in patients with locally advanced non-small cell lung cancer (NSCLC) undergoing neoadjuvant chemotherapy and/or immunotherapy prior to surgical resection.

Patients with stage III NSCLC increasingly receive multimodal treatment strategies combining systemic therapy followed by surgery. While neoadjuvant chemotherapy and immunotherapy have improved oncologic outcomes, these treatments frequently induce treatment-related deconditioning, sarcopenia, fatigue, and reduced cardiopulmonary reserve. Consequently, a subset of patients experiences functional decline significant enough to compromise surgical eligibility. Moreover, thoracic surgery itself is associated with substantial postoperative morbidity, particularly cardiorespiratory complications, and long-term impairment in physical performance.

The PREHAB trial is based on the hypothesis that early, structured, and supervised exercise training initiated concomitantly with systemic therapy and continued until surgery can mitigate treatment-induced physiological deterioration, preserve or enhance cardiorespiratory fitness, and ultimately improve perioperative and postoperative outcomes.

A total of 74 patients will be randomized in a 1:1 ratio to either:

  • Intervention group: participation in a 12-16 week supervised exercise program consisting of three weekly sessions combining endurance and resistance training, delivered by trained physiotherapists.
  • Control group: standard oncologic care without a structured exercise intervention.

The primary endpoint is change in peak oxygen uptake (VO₂peak), measured by cardiopulmonary exercise testing, as an objective marker of cardiorespiratory fitness and surgical resilience.

Secondary endpoints include:

  • Postoperative complication rates
  • Length of hospital stay
  • Pulmonary function parameters
  • Skeletal muscle mass
  • Health-related quality of life

Safety considerations focus primarily on the risk of falls and overexertion, both minimized through professional supervision and individualized exercise prescription.

By targeting the vulnerable neoadjuvant window - when patients are exposed to systemic therapy but have not yet undergone surgery - PREHAB aims to redefine perioperative optimization in locally advanced NSCLC. If positive, this trial could provide high-level evidence supporting the integration of structured exercise prehabilitation into standard multimodal lung cancer care pathways.

03

Conditions studied

  • Locally Advanced Non-small Cell Lung Cancer (NSCLC)

Keywords

  • Non-small cell lung cancer
  • Locally advanced NSCLC
  • Neoadjuvant therapy
  • Immunotherapy
  • Prehabilitation
  • Exercise training
  • VO2peak
  • Cardiopulmonary exercise testing
  • Thoracic surgery
  • Postoperative complications
04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Age ≥18 years.
  • Confirmed diagnosis of stage IIB, IIIA, IIIB or oligo- stage IV NSCLC.
  • Planned induction therapy with either chemotherapy, immunotherapy or a combination of immuno-chemotherapy followed by an anatomical pulmonary resection.
  • Absence of musculoskeletal conditions preventing safe physical exercise.
  • Absence of any history of uncontrolled or unstable cardiac disease.
  • Agreement to participate in the study by signing the study specific form.

Exclusion criteria

Exclusion Criteria:

  • Pregnancy (confirmed by a test if applicable).
  • Induction therapy already initiated.
  • Inability to walk independently.
  • Lack of decision-making capacity.
  • Oxygen-dependency before the initiation of the induction protocol.
  • No capacity for discernment.
  • Does not speak French.
Terms in these criteria, in plain language(2)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Metastases

Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

05

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
74 participants (estimated)

Study arms

  • Experimental
    Intervention

    Intervention group: participation in a 12-16 week supervised exercise program consisting of three weekly sessions combining endurance and resistance training, delivered by trained physiotherapists.

    Procedure: Preoperative Exercise Training

  • No intervention
    Control

    Control group: standard oncologic care without a structured exercise intervention.

Interventions

  • ProcedurePreoperative Exercise Training

    The intervention consists of a structured, supervised pre-operative exercise training program initiated concomitantly with induction chemo- and/or immunotherapy and continued until 24-72 hours prior to surgery. The program is delivered in an outpatient setting and supervised by trained physiotherapists following a standardized protocol across study sites. Participants randomized to the intervention group will complete three sessions per week, each lasting 45-60 minutes, for a total duration of 12 to 16 weeks depending on the length of induction therapy. Each session combines aerobic and resistance training components. Aerobic exercise is performed on a cycle ergometer at an initial intensity of approximately 60% of baseline VO₂peak, with progressive increases in duration and intensity aiming for 30-40 minutes at a Borg perceived exertion score of 4-6. Resistance training targets major upper and lower muscle groups using functional exercises.

06

What researchers measure

Primary outcomes

  1. Change in peak oxygen uptake (VO₂peak) from baseline to pre-surgery

    The primary endpoint is peak oxygen uptake (VO₂peak), measured by standardized cardiopulmonary exercise testing (CPET). VO₂peak reflects the integrative capacity of the cardiovascular, pulmonary, and muscular systems during maximal exertion and is a validated indicator of surgical fitness and perioperative risk. VO₂peak will be assessed at baseline (before induction therapy) and repeated 24-72 hours prior to surgery. The primary analysis will compare pre-surgery VO₂peak between groups using ANCOVA adjusted for baseline VO₂peak.

    Time frame: From baseline to 24-72 hours prior to surgery at approximately 12-16 weeks.

Secondary outcomes

  1. Change in ventilatory efficiency (VE/VCO₂ slope) from baseline to pre-surgery

    VE/VCO₂ slope measured during CPET as an index of ventilatory efficiency and ventilation-perfusion matching. Elevated values are associated with increased perioperative risk. The outcome is the between-group difference at pre-surgery adjusted for baseline value.

    Time frame: From baseline to 24-72 hours prior to surgery at approximately 12-16 weeks.

  2. Change in 6-minute walk distance from baseline to pre-surgery

    Distance walked during the standardized 6-minute walk test (6MWT) performed indoors on a 30-meter corridor according to established guidelines. The outcome is the between-group difference in walking distance at pre-surgery adjusted for baseline.

    Time frame: From baseline to 24-72 hours prior to surgery at approximately 12-16 weeks.

  3. Rate of 30-day postoperative cardiopulmonary complications

    Proportion of patients experiencing at least one predefined cardiopulmonary complication within 30 days after surgery, including atrial fibrillation, pneumonia, prolonged air leak, pulmonary embolism, ARDS, pneumothorax, or myocardial infarction. Between-group comparison.

    Time frame: From surgery to 30 days postoperatively.

  4. Length of postoperative hospital stay

    Number of days from the date of surgery to hospital discharge. Comparison of mean length of stay between intervention and control groups.

    Time frame: From surgery until hospital discharge.

  5. Change in health-related quality of life (EORTC QLQ-C30 global score)

    Health-related quality of life assessed using the EORTC QLQ-C30 questionnaire (version 3.0). The primary QoL endpoint is the global health status/quality of life score. Between-group comparison of change from baseline to pre-surgery.

    Time frame: From baseline to 24-72 hours prior to surgery at approximately 12-16 weeks.

  6. Change in skeletal muscle cross-sectional area on CT imaging

    Skeletal muscle cross-sectional area and radiodensity measured on CT scans at the L3 vertebral level. Change from baseline to pre-surgery compared between groups as an index of sarcopenia and muscle quality.

    Time frame: From baseline to 4-6 weeks prior to surgery at approximately 12 weeks.

  7. Change in pulmonary function (FEV1 and DLCO) from baseline to pre-surgery

    Forced expiratory volume in 1 second (FEV1) and diffusing capacity for carbon monoxide (DLCO) measured using standardized pulmonary function testing. Between-group comparison of change from baseline to pre-surgery.

    Time frame: From baseline to 24-72 hours prior to surgery at approximately 12-16 weeks.

07

Study locations

3 sites
08

References and documents

Individual participant data

Plan to share: Yes — Individual participant data (IPD) underlying the results reported in the publication of the primary and secondary outcomes will be shared. This will include de-identified individual-level data for baseline characteristics, group allocation, primary outcome data (VO₂peak at baseline and pre-surgery), secondary outcome measures (VE/VCO₂ slope, 6-minute walk distance, postoperative complications, length of stay, pulmonary function, skeletal muscle mass, and quality of life scores), and adherence data. All shared data will be fully de-identified in accordance with applicable data protection regulations. The study protocol, statistical analysis plan, and data dictionary will also be made available.

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Start is estimated for Apr 2026; primary completion for Mar 2029, 35 months later.

Of 343 non-industry interventional studies with no phase under Carcinoma, Non-Small-Cell Lung, half reached primary completion within 52 months of starting (the median), counting those still running; a quarter within 28 and three quarters within 98. This study's planned 35 months is below that.

Counting every sponsor, half of 359 studies reached it within 51 months; a quarter within 26 and three quarters within 97.

How these figures are worked out, and which studies are left out of them.

Registered
Mar 4, 2026
First posted
Mar 18, 2026
StartEst.
Apr 2026
Primary completionEst.
Mar 2029
CompletionEst.
Apr 2029
Last update
Mar 18, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Mar 18, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07479407
Lead sponsor
Hôpital du Valais
Responsible party
Sponsor
First posted
Mar 18, 2026
Start date
Apr 2026 (estimated)
Primary completion
Mar 2029 (estimated)
Completion
Apr 2029 (estimated)
Last update
Mar 18, 2026

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Mar 2026. You cannot join it, but the record below documents what was studied.

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