Stage IV non-small cell lung cancer (NSCLC) Cancer
Conditions
Interventions
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 s
Sponsors
University of Thessaly Innovation, Technology Transfer Unit and Entrepreneurship Center "One Planet Thessaly"
Eligibility
Sex/Gender
All
Inclusion criteria
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
Exclusion criteria
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Functional capacity measured using the 6-minute walk test (6MWT) at baseline and after completion of the 8-week pulmonary rehabilitation program. | — |
Secondary
| Measure | Time frame |
|---|---|
| 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. | — |
Countries
Greece
Contacts
Public ContactChrIstIna Lekka
Outcome results
None listed