Lung Cancer, Exercise and Force Development

Study Overview
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Brief Summary
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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
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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.

Official Title
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Exercise in Lung Cancer Patients - Specific Training, Muscle Mass and Force Development

Conditions
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Lung Cancer

Intervention / Treatment
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* Other: Resistance training


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Parallel assignment. The participants will be randomized to either left or right leg resistance training.
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Usual Care<br>Participants receive usual care | |
| Experimental: Usual Care + exercise<br>Participants receive usual care and one-leg resistance exercise training | Other: Resistance training<br>* 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<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Muscle strength/function: Rate of Force Development (RFD) | The between group change in Rate of Force Development (Nm/s) of the knee extensors. Assessed in the CON-TREX MJ dynamometer. | Baseline, 6 weeks, 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Functionality: 6 minutes walk test (6-MWT) | Change in walking distance | Baseline, 6 weeks, 12 weeks | 
| Lean leg mass | The between group change in lean leg mass (kg) assessed by whole-body dual-energy x-ray absorptiometry (DXA) scan | Baseline, 6 weeks, 12 weeks | 
| Functionality: Postural balance | Postural one-leg balance on a 5-cm high, 3-cm wide, and 50-cm long plastic bar. Between group change in number of times the participants steps off the bar or needs support to prevent falling in a period of 1 min. | Baseline, 6 weeks, 12 weeks | 
| Functionality: Sit-to-stand (30s STS) | Change in sit-to-stand in 30 seconds | Baseline, 6 weeks, 12 weeks | 
| Functionality: Sit-to-stand (5reps STS) | Change in time for 5 STS repetitions | Baseline, 6 weeks, 12 weeks | 
| Muscle strength/function: 1 RM | The between group change in 1 repetition maximum in knee-extension and leg-press | Baseline, 6 weeks, 12 weeks | 
| Muscle strength/function: Power | The between group change in maximum isometric knee extension power (Nm). Assessed in the CON-TREX MJ dynamometer. | Baseline, 6 weeks, 12 weeks | 
| Muscle strength/function: Isokinetic strength | The between group change in maximum isokinetic knee extension power (Nm) (60 degrees/s). Assessed in the CON-TREX MJ dynamometer. | Baseline, 6 weeks, 12 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Exercise, Functionality, Resistance training, Muscle, skeletal, Sarcopenia