Lung Cancer, Exercise and Force Development

Trial Title: Lung Cancer, Exercise and Force Development

NCT ID: NCT05778136

Condition: Lung Cancer

Conditions: Official terms:
Lung Neoplasms

Conditions: Keywords:
Exercise
Functionality
Resistance training
Muscle, skeletal
Sarcopenia

Study type: Interventional

Study phase: N/A

Overall status: Recruiting

Study design:

Allocation: Randomized

Intervention model: Parallel Assignment

Intervention model description: Parallel assignment. The participants will be randomized to either left or right leg resistance training.

Primary purpose: Other

Masking: Single (Outcomes Assessor)

Intervention:

Intervention type: Other
Intervention name: Resistance training
Description: Supervised resistance training. 2 sessions/week for 12 weeks. The exercises are one-legged leg-press and one-leg knee extension. Resistance training start-up phase comprises 3 sets of 10 repetitions in each of the two exercises with 50% of 1RM. Resistance training progressive phase comprises 3 sets (leg-press) of 5-8 repetitions (70-90% 1 RM) and 6 sets (knee extension) of 8 repetition (75% 1RM). Rest between sets: 3 minutes
Arm group label: Usual Care + exercise

Summary: This study evaluates the effectiveness of a supervised one-leg resistance training program in patients with inoperable lung cancer with the primary outcome being rate of force development. Study design: Single center, two-armed, parallel-group, randomized controlled trial. The primary outcome being rate of force development after 12 weeks of progressive resistance training.

Detailed description: Muscular dysfunction and sarcopenia are known phenomena in cancer patients, and patients experience reduced muscle function and muscle loss regardless of cancer type or stage. Studies indicate that there are a number of cancer-specific and non-cancer-specific factors that influence muscle dysfunction, such as age, poor nutrition, physical inactivity, cancer pathology and treatment preparations. The decreased muscle function can ultimately lead to cachexia, typically seen in stage III - IV lung cancer patients. Previous studies have focused on 1-RM tests, muscle mass and functionality as outcomes. However, a central aspect of functionality in lung cancer patients may be the muscle's ability to develop force in a short time. The present study therefore has rate of force development as a primary outcome with muscle mass and functionality as supporting outcomes. In addition, the patients in this study will perform one-leg resistance exercise with the other leg as the control leg. This will eliminate the interpersonal bias normally seen in randomized controlled trials.

Criteria for eligibility:
Criteria:
Inclusion Criteria: - patients (men and women) from the age of 18 years and above; patients with lung cancer (NSCLC stage III - IV and SCLC ED); patients with performance stage 0-2 according to WHO criteria Exclusion Criteria: - Patients where the doctor has listed contraindications for physical activity in the medical record; documented bone and brain metastases; persistent medullary plasia; patients on anticoagulation treatment; diagnosed symptomatic cardiac disease, including clinical congestive heart disease, arrhythmia requiring treatment or diagnosed myocardial infarction within the last three months; pericardial exudate; patients in terminal treatment; senile dementia and psychotic patients.

Gender: All

Minimum age: 18 Years

Maximum age: N/A

Healthy volunteers: No

Locations:

Facility:
Name: University hospital Copenhagen

Address:
City: København Ø
Zip: 2100
Country: Denmark

Status: Recruiting

Contact:
Last name: Morten Quist, PhD

Phone: +4523467919
Email: morten.quist@regionh.dk

Investigator:
Last name: Morten Quist, M. HS.
Email: Principal Investigator

Start date: March 31, 2023

Completion date: December 1, 2023

Lead sponsor:
Agency: Rigshospitalet, Denmark
Agency class: Other

Source: Rigshospitalet, Denmark

Record processing date: ClinicalTrials.gov processed this data on November 12, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT05778136