NCT05778136

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
20

participants targeted

Target at below P25 for not_applicable lung-cancer

Timeline
Completed

Started Mar 2023

Shorter than P25 for not_applicable lung-cancer

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 1, 2023

Completed
20 days until next milestone

First Posted

Study publicly available on registry

March 21, 2023

Completed
10 days until next milestone

Study Start

First participant enrolled

March 31, 2023

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2023

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2023

Completed
Last Updated

April 13, 2023

Status Verified

April 1, 2023

Enrollment Period

4 months

First QC Date

March 1, 2023

Last Update Submit

April 12, 2023

Conditions

Lung Cancer

Keywords

ExerciseFunctionalityResistance trainingMuscle, skeletalSarcopenia

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (8)

  • Functionality: 6 minutes walk test (6-MWT)

    Baseline, 6 weeks, 12 weeks

  • Lean leg mass

    Baseline, 6 weeks, 12 weeks

  • Functionality: Postural balance

    Baseline, 6 weeks, 12 weeks

  • Functionality: Sit-to-stand (30s STS)

    Baseline, 6 weeks, 12 weeks

  • Functionality: Sit-to-stand (5reps STS)

    Baseline, 6 weeks, 12 weeks

  • +3 more secondary outcomes

Study Arms (2)

Usual Care

NO INTERVENTION

Participants receive usual care

Usual Care + exercise

EXPERIMENTAL

Participants receive usual care and one-leg resistance exercise training

Other: Resistance training

Interventions

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

Usual Care + exercise

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University hospital Copenhagen

København Ø, Please Select, 2100, Denmark

RECRUITING

MeSH Terms

Conditions

Lung NeoplasmsMotor ActivitySarcopenia

Interventions

Resistance Training

Condition Hierarchy (Ancestors)

Respiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SiteNeoplasmsLung DiseasesRespiratory Tract DiseasesBehaviorMuscular AtrophyNeuromuscular ManifestationsNeurologic ManifestationsNervous System DiseasesAtrophyPathological Conditions, AnatomicalPathological Conditions, Signs and SymptomsSigns and Symptoms

Intervention Hierarchy (Ancestors)

Exercise TherapyRehabilitationAftercareContinuity of Patient CarePatient CareTherapeuticsPhysical Therapy ModalitiesPhysical Conditioning, HumanExerciseMotor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • Morten Quist, ph.d.

    Rigshospitalet, Denmark

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Morten Quist, ph.d.

CONTACT

+4535457335morten.quist@regionh.dk

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
OTHER
Intervention Model
PARALLEL
Model Details: Parallel assignment. The participants will be randomized to either left or right leg resistance training.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

March 1, 2023

First Posted

March 21, 2023

Study Start

March 31, 2023

Primary Completion

August 1, 2023

Study Completion

December 1, 2023

Last Updated

April 13, 2023

Record last verified: 2023-04

Data Sharing

IPD Sharing
Will not share

Locations

DK(1)