Lung Cancer, Exercise and Force Development
- Conditions
- Lung Cancer
- Interventions
- Other: Resistance training
- Registration Number
- NCT05778136
- Lead Sponsor
- Rigshospitalet, Denmark
- 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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 20
- 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
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Usual Care + exercise Resistance training Participants receive usual care and one-leg resistance exercise training
- Primary Outcome Measures
Name Time Method Muscle strength/function: Rate of Force Development (RFD) Baseline, 6 weeks, 12 weeks The between group change in Rate of Force Development (Nm/s) of the knee extensors. Assessed in the CON-TREX MJ dynamometer.
- Secondary Outcome Measures
Name Time Method Functionality: Postural balance Baseline, 6 weeks, 12 weeks 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.
Muscle strength/function: 1 RM Baseline, 6 weeks, 12 weeks The between group change in 1 repetition maximum in knee-extension and leg-press
Functionality: 6 minutes walk test (6-MWT) Baseline, 6 weeks, 12 weeks Change in walking distance
Functionality: Sit-to-stand (5reps STS) Baseline, 6 weeks, 12 weeks Change in time for 5 STS repetitions
Functionality: Sit-to-stand (30s STS) Baseline, 6 weeks, 12 weeks Change in sit-to-stand in 30 seconds
Muscle strength/function: Isokinetic strength Baseline, 6 weeks, 12 weeks The between group change in maximum isokinetic knee extension power (Nm) (60 degrees/s). Assessed in the CON-TREX MJ dynamometer.
Lean leg mass Baseline, 6 weeks, 12 weeks The between group change in lean leg mass (kg) assessed by whole-body dual-energy x-ray absorptiometry (DXA) scan
Muscle strength/function: Power Baseline, 6 weeks, 12 weeks The between group change in maximum isometric knee extension power (Nm). Assessed in the CON-TREX MJ dynamometer.
Trial Locations
- Locations (1)
University hospital Copenhagen
🇩🇰København Ø, Please Select, Denmark