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Clinical Trials/NCT05778136
NCT05778136
Recruiting
Not Applicable

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

Rigshospitalet, Denmark1 site in 1 country20 target enrollmentMarch 31, 2023
ConditionsLung Cancer

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Lung Cancer
Sponsor
Rigshospitalet, Denmark
Enrollment
20
Locations
1
Primary Endpoint
Muscle strength/function: Rate of Force Development (RFD)
Status
Recruiting
Last Updated
3 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
March 31, 2023
End Date
December 1, 2023
Last Updated
3 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Morten Quist

Associate Professor

Rigshospitalet, Denmark

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.

Outcomes

Primary Outcomes

Muscle strength/function: Rate of Force Development (RFD)

Time Frame: 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 Outcomes

  • Functionality: 6 minutes walk test (6-MWT)(Baseline, 6 weeks, 12 weeks)
  • Functionality: Sit-to-stand (5reps STS)(Baseline, 6 weeks, 12 weeks)
  • Functionality: Sit-to-stand (30s STS)(Baseline, 6 weeks, 12 weeks)
  • Muscle strength/function: Isokinetic strength(Baseline, 6 weeks, 12 weeks)
  • Lean leg mass(Baseline, 6 weeks, 12 weeks)
  • Muscle strength/function: Power(Baseline, 6 weeks, 12 weeks)
  • Functionality: Postural balance(Baseline, 6 weeks, 12 weeks)
  • Muscle strength/function: 1 RM(Baseline, 6 weeks, 12 weeks)

Study Sites (1)

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