Effect of pulmonary rehabilitation on clinical outcomes in patients with lung cancer
| ISRCTN | ISRCTN73363779 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN73363779 |
- Submission date
- 18/07/2025
- Registration date
- 21/07/2025
- Last edited
- 21/07/2025
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Cancer
Plain English summary of protocol
Background and study aims
This study is looking at whether a supervised exercise and breathing program can help people with advanced lung cancer feel better, move more easily, and improve their quality of life while they are receiving immunotherapy. The researchers also want to see if this kind of rehabilitation can reduce inflammation in the body and help people cope better with their treatment.
Who can participate?
People aged 35 years and over who have stage IV non-small cell lung cancer and are being treated with immunotherapy may be able to join. To take part, they need to be able to walk for six minutes without using a walking aid. People with serious heart problems, certain nerve or muscle conditions, low blood counts, or other health issues may not be eligible.
What does the study involve?
Participants are randomly placed into one of two groups:
-One group takes part in a supervised rehabilitation program at the GNA “SOTIRIA” hospital in Athens. This includes 16 sessions over eight weeks, with each session lasting about an hour. The sessions include cycling, strength exercises, breathing techniques, and training to improve balance and walking.
-The other group receives usual care, which includes a single educational session about the benefits of physical activity, but no structured exercise program.
Researchers will measure changes in walking ability, muscle strength, quality of life, and blood test results at the beginning and end of the study.
What are the possible benefits and risks of participating?
There are no known risks, as all activities are supervised by trained professionals and approved by each participant’s doctor. Participants may feel better physically and emotionally, but even if they don’t benefit personally, their involvement could help improve care for future patients.
Where is the study run from?
The study is being carried out at the GNA “SOTIRIA” hospital in Athens, Greece.
When is the study starting and how long is it expected to run for?
November 2020 to October 2024
Who is funding the study?
The study is funded by the Special Account for Research Grants of the University of Thessaly through a scholarship program for doctoral candidates (Greece)
Who is the main contact?
Christina Lekka, christiana.lekka@gmail.com
Contact information
Public, Scientific, Principal Investigator
vasileos georgiou V19, Filothei
Athens
15237
Greece
 ORCID ID |
0009-0002-1730-373X |
|---|---|
| Phone | +30-6946850575 |
| clekka@idef.gr |
Study information
| Study design | Single-centre interventional randomized controlled open-label trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital, University/medical school/dental school |
| Study type | Quality of life, Efficacy |
| Participant information sheet | No participant information sheet available |
| Scientific title | Effect of pulmonary rehabilitation on functional capacity, quality of life and blood inflammatory indices in stage IV lung cancer patients |
| Study objectives | This randomized controlled trial aims to evaluate the impact of a 16-session outpatient pulmonary rehabilitation (PR) program on multiple clinical outcomes in patients with stage IV non-small cell lung cancer (NSCLC) undergoing first-line immunotherapy, with or without chemotherapy. The primary endpoint is the enhancement of functional capacity, as measured by the distance covered during the 6-minute walk test (6MWT). Based on the existing literature and theoretical frameworks, we hypothesize that: 1. Participation in the PR program will significantly improve functional capacity. 2. The PR intervention will lead to significant improvements in overall quality of life and will attenuate treatment-related adverse effects, particularly fatigue and dyspnea. 3. The PR program will positively influence immunotherapy efficacy, as reflected by prolongation of progression-free survival (PFS) and favorable modulation of relevant blood-based biomarkers. 4. The intervention will result in increased muscular strength and enhanced cardiorespiratory fitness. 5. The PR program will improve gait performance and related ambulatory parameters. 6. Engagement in the PR program will support improvements in fine motor dexterity. |
| Ethics approval(s) |
Approved 30/04/2020, Sotiria Hospital Research Ethics Committee (1st Health Region of Attica General Hospital for Chest Diseases of Athens "SOTIRIA" 152 Mesogeion Avenue, Αthens, 11527, Greece; +30 -210 7757156; epi.symb@sotiria.gr), ref: 11622 / 30.4.20 |
| Health condition(s) or problem(s) studied | Stage IV non-small cell lung cancer (NSCLC) |
| Intervention | Single-centre interventional randomized controlled open-label trial assessing the impact of a pulmonary rehabilitation program on quality of life, functional capacity, and inflammatory biomarkers in stage IV lung cancer patients receiving first-line immunotherapy. Participants were randomized based on 6MWT performance into intervention and usual care groups, with allocation concealment maintained for those conducting the randomisation process. |
| Intervention type | Behavioural |
| Primary outcome measure | Functional capacity measured using the 6-minute walk test (6MWT) at baseline and after completion of the 8-week pulmonary rehabilitation program. |
| Secondary outcome measures | 1. Fine motor dexterity measured using the 9-Hole Peg Test (9HPT) at baseline and two months post-intervention. 2. Functional capacity measured using the Short Physical Performance Battery (SPPB), and isometric quadriceps force (QF) measured using the Biodex System 4 dynamometer (Biodex Medical Systems, Shirley, NY, USA) at baseline and two months post-intervention. 3. Quality of life measured using the COPD Assessment Test (CAT), the Cancer-Related Fatigue Scale (CFS), and the EQ-5D VAS scale, at baseline and two months after completion of the rehabilitation program. 4. Blood inflammatory biomarkers (NLR, PLR, LMR, SII) measured using complete blood counts at baseline and two months post-intervention . 5. Progression-free survival (PFS) assessed using radiological progression and/or significant clinical decline (e.g., new or worsening respiratory symptoms or ECOG performance status decline ≥1) at baseline and four months post-intervention. |
| Overall study start date | 11/11/2020 |
| Completion date | 20/10/2024 |
Eligibility
| Participant type(s) | Healthy volunteer, Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 35 Years |
| Upper age limit | 85 Years |
| Sex | Both |
| Target number of participants | 72 |
| Total final enrolment | 72 |
| Key inclusion criteria | 1. >35 years 2. Receiving immunotherapy as primary treatment 3. Had not undergone thoracic surgery and 4. Were able to walk 6 minutes without walking aids |
| Key exclusion criteria | 1. History of cognitive or neuromuscular disorders 2. Musculoskeletal impairments affecting walking ability and inability to read and understand Greek language 3. Patients with ECOG performance status ≥2 4. Unstable cardiac disease 5. Dyspnoea classified as NYHA class II-IV 6. Recent cerebrovascular event 7. Thrombocytopenia (platelet count<50,000/μ L) 8. Low hemoglobin levels (<10.0g/dl) 9. High risk of pathological fracture as determined by the Mirel’s scoring system and Brief Pain Inventory (BPI) for bone pain |
| Date of first enrolment | 06/12/2022 |
| Date of final enrolment | 10/10/2024 |
Locations
Countries of recruitment
- Greece
Study participating centres
Athens
11527
Greece
Athens
11527
Greece
Sponsor information
Government
Giannitson & lachana, palaia - building Tsalapata
Volos
38 334
Greece
| Phone | +30 242100 6406 |
|---|---|
| ee@uth.g | |
| Website | https://ee.uth.gr/el/node/20877 |
Funders
Funder type
University/education
Government organisation / Local government
- Location
- Greece
Results and Publications
| Intention to publish date | 30/09/2025 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request |
| Publication and dissemination plan | Planned publication in a peer-reviewed journal |
| IPD sharing plan | Individual participant data will be shared upon reasonable request form christiana.lekka@gmail.com. Data will be anonymized and made available via institutional repository after publication. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Protocol file | 21/07/2025 | No | No |
Additional files
Editorial Notes
21/07/2025: Trial's existence confirmed by Sotiria Hospital Research Ethics Committee.
