Lung CancerNCT05778136
Lung Cancer, Exercise and Force Development
A study testing Resistance training in people with Lung Cancer, run by Copenhagen University Hospital, Rigshospitalet at 1 site in Denmark.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lung Cancer
- What is being tested?
- Resistance training
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteDenmark
- Study dates
- 31 Mar 2023to 1 Dec 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Denmark1 site, 1 recruiting
- Recruiting
University hospital Copenhagen
København Ø, Please Select, 2100
Morten Quist, PhD, +4523467919, morten.quist@regionh.dk
Morten Quist, M. HS.
About this study
Official title: Exercise in Lung Cancer Patients - Specific Training, Muscle Mass and Force Development
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.
Read the 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.
- Conditions
- Lung Cancer
- Being tested
- Resistance training
- Keywords
- Exercise, Functionality, Resistance training, Muscle, skeletal, Sarcopenia
- Medical subject headings
- Lung Neoplasms, Motor Activity, Sarcopenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Resistance trainingOther
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
| Study group | Role | What they receive |
|---|---|---|
| Usual Care | No intervention | Participants receive usual care |
| Usual Care + exercise | Experimental | Participants receive usual care and one-leg resistance exercise training Receives: Other: Resistance training |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline, 6 weeks, 12 weeks
Secondary outcomes (8)
Functionality: 6 minutes walk test (6-MWT)
Change in walking distance
Measured: 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
Measured: 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.
Measured: Baseline, 6 weeks, 12 weeks
Functionality: Sit-to-stand (30s STS)
Change in sit-to-stand in 30 seconds
Measured: Baseline, 6 weeks, 12 weeks
Functionality: Sit-to-stand (5reps STS)
Change in time for 5 STS repetitions
Measured: Baseline, 6 weeks, 12 weeks
Muscle strength/function: 1 RM
The between group change in 1 repetition maximum in knee-extension and leg-press
Measured: 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.
Measured: 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.
Measured: Baseline, 6 weeks, 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Mar 2023
- Study start31 Mar 2023
- Primary completion1 Aug 2023 (estimated)
- Study completion1 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lung CancerStudies of the same condition, open and under way.
- More trials run by Copenhagen University Hospital, RigshospitaletThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Parallel assignment. The participants will be randomized to either left or right leg resistance training.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Copenhagen University Hospital, Rigshospitalet
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Morten Quist, Copenhagen University Hospital, Rigshospitalet
- Investigators
- Morten Quist, ph.d., Principal investigator, Copenhagen University Hospital, Rigshospitalet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05778136
- Sponsor's protocol ID
- MQCLFW
- Other IDs
- H-22073691
- Status last verified
- Apr 2023
- First submitted
- 1 Mar 2023
- Last updated
- 13 Apr 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Exercise in Lung Cancer Patients - Specific Training, Muscle Mass and Force Development
- ClinicalTrials.gov ID
- NCT05778136
- Acronym / sponsor ID
- MQCLFW
- Conditions
- Lung Cancer
- Keywords
- Exercise, Functionality, Resistance training, Muscle, skeletal, Sarcopenia
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Copenhagen University Hospital, RigshospitaletUniversity, hospital or other
- Study start
- 31 Mar 2023 (actual)
- Primary completion
- 1 Aug 2023 (estimated)
- Study completion
- 1 Dec 2023 (estimated)
- First posted
- 21 Mar 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Parallel assignment. The participants will be randomized to either left or right leg resistance training.
| Arm | Type | Receives |
|---|---|---|
| Usual Care | No intervention | –Participants receive usual care |
| Usual Care + exercise | Experimental | Other: Resistance trainingParticipants receive usual care and one-leg resistance exercise training |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Resistance trainingSupervised 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 | Other | Usual Care + exercise |
Primary outcome
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.
8 secondary outcomes
Functionality: 6 minutes walk test (6-MWT)
Time frame: Baseline, 6 weeks, 12 weeks
Lean leg mass
Time frame: Baseline, 6 weeks, 12 weeks
Functionality: Postural balance
Time frame: Baseline, 6 weeks, 12 weeks
Functionality: Sit-to-stand (30s STS)
Time frame: Baseline, 6 weeks, 12 weeks
Functionality: Sit-to-stand (5reps STS)
Time frame: Baseline, 6 weeks, 12 weeks
Muscle strength/function: 1 RM
Time frame: Baseline, 6 weeks, 12 weeks
Muscle strength/function: Power
Time frame: Baseline, 6 weeks, 12 weeks
Muscle strength/function: Isokinetic strength
Time frame: Baseline, 6 weeks, 12 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Apr 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Morten Quist, ph.d. principal investigator
Copenhagen University Hospital, Rigshospitalet
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Resistance training in people with Lung Cancer, run by Copenhagen University Hospital, Rigshospitalet at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 13 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Morten Quist, ph.d. (+4535457335 ext. +4523467919, morten.quist@regionh.dk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Muscle strength/function: Rate of Force Development (RFD) (time frame: Baseline, 6 weeks, 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Apr 2023.