Lung Cancer, Exercise and Force Development

Lung Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05778136
• Other study ID #: MQCLFW
• Secondary ID: H-22073691
• Status: Recruiting
• Phase: N/A
• Start date: March 31, 2023
• Est. completion date: December 1, 2023

Study information

• Verified date: April 2023
• Source: Rigshospitalet, Denmark
• Contact: Morten Quist, ph.d.
• Phone: +4535457335
• Email: morten.quist[@]regionh.dk
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: December 1, 2023
• Est. primary completion date: August 1, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Lung Cancer
• Lung Neoplasms

Intervention

Other:
• Resistance training
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

Locations

Country	Name	City	State
Denmark	University hospital Copenhagen	København Ø	Please Select

Sponsors (1)

Lead Sponsor	Collaborator
Rigshospitalet, Denmark

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Functionality: 6 minutes walk test (6-MWT)	Change in walking distance	Baseline, 6 weeks, 12 weeks
Secondary	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
Secondary	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
Secondary	Functionality: Sit-to-stand (30s STS)	Change in sit-to-stand in 30 seconds	Baseline, 6 weeks, 12 weeks
Secondary	Functionality: Sit-to-stand (5reps STS)	Change in time for 5 STS repetitions	Baseline, 6 weeks, 12 weeks
Secondary	Muscle strength/function: 1 RM	The between group change in 1 repetition maximum in knee-extension and leg-press	Baseline, 6 weeks, 12 weeks
Secondary	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
Secondary	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