Clinical trial NCT05778136: Lung Cancer, Exercise and Force Development
Official title: Exercise in Lung Cancer Patients - Specific Training, Muscle Mass and Force Development
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Lung Cancer
Keywords: Exercise
Functionality
Resistance training
Muscle, skeletal
Sarcopenia
Lead sponsor: Rigshospitalet, Denmark
Sponsor class: OTHER
First posted: 2023-03-21
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Parallel assignment. The participants will be randomized to either left or right leg resistance training.
Primary purpose: OTHER

Brief 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.

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.

Primary outcomes:
measure: Muscle strength/function: Rate of Force Development (RFD)
timeFrame: Baseline, 6 weeks, 12 weeks
Secondary outcomes:
measure: Functionality: 6 minutes walk test (6-MWT)
timeFrame: Baseline, 6 weeks, 12 weeks
measure: Lean leg mass
timeFrame: Baseline, 6 weeks, 12 weeks
measure: Functionality: Postural balance
timeFrame: Baseline, 6 weeks, 12 weeks
measure: Functionality: Sit-to-stand (30s STS)
timeFrame: Baseline, 6 weeks, 12 weeks
measure: Functionality: Sit-to-stand (5reps STS)
timeFrame: Baseline, 6 weeks, 12 weeks
measure: Muscle strength/function: 1 RM
timeFrame: Baseline, 6 weeks, 12 weeks
measure: Muscle strength/function: Power
timeFrame: Baseline, 6 weeks, 12 weeks
measure: Muscle strength/function: Isokinetic strength
timeFrame: Baseline, 6 weeks, 12 weeks
Other outcomes:
Locations:
city: København Ø
country: Denmark
facility: University hospital Copenhagen
state: Please Select
Study officials:
affiliation: Rigshospitalet, Denmark
name: Morten Quist, ph.d.
role: PRINCIPAL_INVESTIGATOR
References: