NCT01048762

Brief Summary

The purpose of this investigation is to determine the effects of exercise training on quality of life and physical capacity, 3 months and 1 year after radical operation for pulmonary cancer.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
78

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Feb 2006

Typical duration for phase_2

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2006

Completed
3.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2010

Completed
12 days until next milestone

First Submitted

Initial submission to the registry

January 13, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

January 14, 2010

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2010

Completed
Last Updated

October 22, 2015

Status Verified

October 1, 2015

Enrollment Period

3.9 years

First QC Date

January 13, 2010

Last Update Submit

October 21, 2015

Conditions

Pulmonary Cancer

Keywords

pulmonary cancerradically operatedexercise trainingdyspnea counselingquality of lifephysical therapy

Outcome Measures

Primary Outcomes (1)

  • Changes in selv reported quality of life and physical capacity 4 months after inclusion measured by SF-36 and 6MWT

    4 months after inclusion

Secondary Outcomes (2)

  • Changes in selv reported quality of life and physical capacity 1 year after inclusion, measured by SF-36 and 6MWT

    1 year after inclusion

  • Changes in lungfunction 4 months and 1 year after inclusion (FEV1, FVC and FEV1/FVC)

    4 months and 1 year after inclusion

Study Arms (2)

supervised exercise training

ACTIVE COMPARATOR

Intervention: supervised exercise training and dyspnea counseling in groups for 10 weeks Instruction on home based exercise training

Other: physical exercise and dyspnoea counselingOther: home training

one instruction on homebased exercises

SHAM COMPARATOR

One instruction on home based exercise training and dyspnea management

Other: home training

Interventions

physical exercise and dyspnoea counselingOTHER

Exercise training in group, 1 hour once a week for 10 weeks, based om aerobic exercises 60-80% of VO2 max (Borg 11-12), resistance training and dyspnea counseling. Participants are urge to exercise training for at least twice a week.

Also known as: aerobic exercise training and resistance training, dyspnea counseling, training in groups
supervised exercise training
home trainingOTHER

one instruction in home based exercise training

Also known as: home based exercises
one instruction on homebased exercisessupervised exercise training

Eligibility Criteria

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

You may qualify if:

  • patients who are radically operated for pulmonary cancer at Aalbor Hospital, Aarhus University Hospital

You may not qualify if:

  • not radically operated
  • cannot speak and read Danish
  • cannot cooperate in tests due to poor mental health
  • patients who undergo rehabilitation at other centres
  • cannot perform walking test due to physical impairment

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Rehabilitation, Aalborg Hospital, Aarhus University Hospital

Aalborg, 9100, Denmark

Location

MeSH Terms

Conditions

Lung Neoplasms

Interventions

ExerciseResistance TrainingPopulation Groups

Condition Hierarchy (Ancestors)

Respiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SiteNeoplasmsLung DiseasesRespiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological PhenomenaExercise TherapyRehabilitationAftercareContinuity of Patient CarePatient CareTherapeuticsPhysical Therapy ModalitiesPhysical Conditioning, HumanDemographyPopulation Characteristics

Study Officials

  • Vitautas Nekrasas, Chief doctor

    Department of Cardiothoracic Surgery, Centre for Cardiovascular Research, Aalborg Hospital, Aarhus University Hospital

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Physiotherapist

Study Record Dates

First Submitted

January 13, 2010

First Posted

January 14, 2010

Study Start

February 1, 2006

Primary Completion

January 1, 2010

Study Completion

September 1, 2010

Last Updated

October 22, 2015

Record last verified: 2015-10

Locations

DK(1)