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Lung Cancer, Exercise and Force Development

Primary Purpose

Lung Cancer

Status
Recruiting
Phase
Not Applicable
Locations
Denmark
Study Type
Interventional
Intervention
Resistance training
Sponsored by
Rigshospitalet, Denmark
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Lung Cancer focused on measuring Exercise, Functionality, Resistance training, Muscle, skeletal, Sarcopenia

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • University hospital CopenhagenRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

Usual Care

Usual Care + exercise

Arm Description

Participants receive usual care

Participants receive usual care and one-leg resistance exercise training

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Functionality: 6 minutes walk test (6-MWT)
Change in walking distance
Lean leg mass
The between group change in lean leg mass (kg) assessed by whole-body dual-energy x-ray absorptiometry (DXA) scan
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.
Functionality: Sit-to-stand (30s STS)
Change in sit-to-stand in 30 seconds
Functionality: Sit-to-stand (5reps STS)
Change in time for 5 STS repetitions
Muscle strength/function: 1 RM
The between group change in 1 repetition maximum in knee-extension and leg-press
Muscle strength/function: Power
The between group change in maximum isometric knee extension power (Nm). Assessed in the CON-TREX MJ dynamometer.
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.

Full Information

First Posted
March 1, 2023
Last Updated
April 12, 2023
Sponsor
Rigshospitalet, Denmark
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1. Study Identification

Unique Protocol Identification Number
NCT05778136
Brief Title
Lung Cancer, Exercise and Force Development
Official Title
Exercise in Lung Cancer Patients - Specific Training, Muscle Mass and Force Development
Study Type
Interventional

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Recruiting
Study Start Date
March 31, 2023 (Actual)
Primary Completion Date
August 1, 2023 (Anticipated)
Study Completion Date
December 1, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Rigshospitalet, Denmark

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lung Cancer
Keywords
Exercise, Functionality, Resistance training, Muscle, skeletal, Sarcopenia

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Parallel assignment. The participants will be randomized to either left or right leg resistance training.
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
20 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Usual Care
Arm Type
No Intervention
Arm Description
Participants receive usual care
Arm Title
Usual Care + exercise
Arm Type
Experimental
Arm Description
Participants receive usual care and one-leg resistance exercise training
Intervention Type
Other
Intervention Name(s)
Resistance training
Intervention Description
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
Primary Outcome Measure Information:
Title
Muscle strength/function: Rate of Force Development (RFD)
Description
The between group change in Rate of Force Development (Nm/s) of the knee extensors. Assessed in the CON-TREX MJ dynamometer.
Time Frame
Baseline, 6 weeks, 12 weeks
Secondary Outcome Measure Information:
Title
Functionality: 6 minutes walk test (6-MWT)
Description
Change in walking distance
Time Frame
Baseline, 6 weeks, 12 weeks
Title
Lean leg mass
Description
The between group change in lean leg mass (kg) assessed by whole-body dual-energy x-ray absorptiometry (DXA) scan
Time Frame
Baseline, 6 weeks, 12 weeks
Title
Functionality: Postural balance
Description
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.
Time Frame
Baseline, 6 weeks, 12 weeks
Title
Functionality: Sit-to-stand (30s STS)
Description
Change in sit-to-stand in 30 seconds
Time Frame
Baseline, 6 weeks, 12 weeks
Title
Functionality: Sit-to-stand (5reps STS)
Description
Change in time for 5 STS repetitions
Time Frame
Baseline, 6 weeks, 12 weeks
Title
Muscle strength/function: 1 RM
Description
The between group change in 1 repetition maximum in knee-extension and leg-press
Time Frame
Baseline, 6 weeks, 12 weeks
Title
Muscle strength/function: Power
Description
The between group change in maximum isometric knee extension power (Nm). Assessed in the CON-TREX MJ dynamometer.
Time Frame
Baseline, 6 weeks, 12 weeks
Title
Muscle strength/function: Isokinetic strength
Description
The between group change in maximum isokinetic knee extension power (Nm) (60 degrees/s). Assessed in the CON-TREX MJ dynamometer.
Time Frame
Baseline, 6 weeks, 12 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Morten Quist, ph.d.
Phone
+4535457335
Ext
+4523467919
Email
morten.quist@regionh.dk
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Morten Quist, ph.d.
Organizational Affiliation
Rigshospitalet, Denmark
Official's Role
Principal Investigator
Facility Information:
Facility Name
University hospital Copenhagen
City
København Ø
State/Province
Please Select
ZIP/Postal Code
2100
Country
Denmark
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Morten Quist, PhD
Phone
+4523467919
Email
morten.quist@regionh.dk
First Name & Middle Initial & Last Name & Degree
Morten Quist, M. HS.

12. IPD Sharing Statement

Plan to Share IPD
No

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