NCT04502654

Brief Summary

The main aim of this research is to compare the functional recovery after discharge with the preoperative physical activity as a hypothesis generating study.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
32

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Sep 2020

Shorter than P25 for all trials

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

First Submitted

Initial submission to the registry

July 31, 2020

Completed
6 days until next milestone

First Posted

Study publicly available on registry

August 6, 2020

Completed
1 month until next milestone

Study Start

First participant enrolled

September 15, 2020

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 21, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 21, 2021

Completed
Last Updated

August 16, 2021

Status Verified

August 1, 2021

Enrollment Period

10 months

First QC Date

July 31, 2020

Last Update Submit

August 13, 2021

Conditions

Lung NeoplasmsRehabilitationExercisePain, PostoperativePost Discharge

Keywords

Functional recoveryEnhanced recovery after surgeryVideo-assisted thoracoscopic surgeryLobectomy

Outcome Measures

Primary Outcomes (1)

  • Length of functional rehabilitation

    Investigators will calculate preperative Activity Counts per day as a baseline then being compared to postoperative Activity Counts per day until one day when both Counts is equal. Length of functional rehabilitation defines that duration from surgical day to the day when both Counts is equal.

    Through study completion, minimum 7 days

Secondary Outcomes (9)

  • Quality of recovery

    Through study completion, an average of 14 days

  • The quantization of fatigue

    Through study completion, an average of 14 days

  • The quantization of pain

    Through study completion, an average of 14 days

  • The quantization of vomiting.

    Through study completion, an average of 14 days

  • The quantization of nausea.

    Through study completion, an average of 14 days

  • +4 more secondary outcomes

Study Arms (1)

Pilot group

As a pilot Group for observating variable rehabilitation under individual baselines.

Device: Actiwatch 2 (Philips Respironics, Murrysville, USA)

Interventions

Actiwatch 2 (Philips Respironics, Murrysville, USA)DEVICE

Actiwatch 2 is an unobtrusive, waterproof, light sensor and wrist-worn device (weight 16.0g, size 4.3 cm\* 2.3 cm\* 1.0 cm), containing a tri-axial accelerometer able to records a digitally integrated measure of gross motor activity (a piezoelectric sensor to detect vertical accelerations at the wrist between 0.5 and 2.0 g with a frequency response range between 0.35-7.5 Hz). Activity counts from the device reflect the peak acceleration detected over each epoch and are used in determining sleep and wake intervals, which can be used to rest-activity patterns, quality of physical activity and sleep for 15-60 seconds/ epoch, 24 hours/ day, 2 weeks.

Pilot group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients who will be submitted to video-assisted thoracoscopic surgery lobectomy.

You may qualify if:

  • VATS-L
  • Speaks and understands Danish or English.
  • Informed consent obtained

You may not qualify if:

  • Co-VATS-L.
  • on the wheelchair.
  • Living in nurse home.
  • Using rollator to assist to walk.
  • Unwilling to place the Actiwatch 2 or execute PPE.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Rigshospitalet

Copenhagen, Denmark

Location

Related Publications (15)

  • Bray F, Ferlay J, Soerjomataram I, Siegel RL, Torre LA, Jemal A. Global cancer statistics 2018: GLOBOCAN estimates of incidence and mortality worldwide for 36 cancers in 185 countries. CA Cancer J Clin. 2018 Nov;68(6):394-424. doi: 10.3322/caac.21492. Epub 2018 Sep 12.

    PMID: 30207593BACKGROUND

  • Bendixen M, Jorgensen OD, Kronborg C, Andersen C, Licht PB. Postoperative pain and quality of life after lobectomy via video-assisted thoracoscopic surgery or anterolateral thoracotomy for early stage lung cancer: a randomised controlled trial. Lancet Oncol. 2016 Jun;17(6):836-844. doi: 10.1016/S1470-2045(16)00173-X. Epub 2016 May 6.

    PMID: 27160473BACKGROUND

  • Yang CJ, Kumar A, Deng JZ, Raman V, Lui NS, D'Amico TA, Berry MF. A National Analysis of Short-term Outcomes and Long-term Survival Following Thoracoscopic Versus Open Lobectomy for Clinical Stage II Non-Small-Cell Lung Cancer. Ann Surg. 2021 Mar 1;273(3):595-605. doi: 10.1097/SLA.0000000000003231.

    PMID: 30946089BACKGROUND

  • Marijic P, Walter J, Schneider C, Schwarzkopf L. Cost and survival of video-assisted thoracoscopic lobectomy versus open lobectomy in lung cancer patients: a propensity score-matched study. Eur J Cardiothorac Surg. 2020 Jan 1;57(1):92-99. doi: 10.1093/ejcts/ezz157.

    PMID: 31157367BACKGROUND

  • Iwata H, Shirahashi K, Yamamoto H, Marui T, Matsumoto S, Mizuno Y, Matsumoto M, Mitta S, Miyamoto Y, Komuro H. Propensity score-matching analysis of hybrid video-assisted thoracoscopic surgery and thoracoscopic lobectomy for clinical stage I lung cancerdagger. Eur J Cardiothorac Surg. 2016 Apr;49(4):1063-7. doi: 10.1093/ejcts/ezv296. Epub 2015 Aug 30.

    PMID: 26324682BACKGROUND

  • Kehlet H. Multimodal approach to control postoperative pathophysiology and rehabilitation. Br J Anaesth. 1997 May;78(5):606-17. doi: 10.1093/bja/78.5.606.

    PMID: 9175983BACKGROUND

  • Batchelor TJP, Rasburn NJ, Abdelnour-Berchtold E, Brunelli A, Cerfolio RJ, Gonzalez M, Ljungqvist O, Petersen RH, Popescu WM, Slinger PD, Naidu B. Guidelines for enhanced recovery after lung surgery: recommendations of the Enhanced Recovery After Surgery (ERAS(R)) Society and the European Society of Thoracic Surgeons (ESTS). Eur J Cardiothorac Surg. 2019 Jan 1;55(1):91-115. doi: 10.1093/ejcts/ezy301.

    PMID: 30304509BACKGROUND

  • Kehlet H. Enhanced postoperative recovery: good from afar, but far from good? Anaesthesia. 2020 Jan;75 Suppl 1:e54-e61. doi: 10.1111/anae.14860.

    PMID: 31903577BACKGROUND

  • Wang KY, Chang NW, Wu TH, Hsu CC, Lee YH, Lee SC. Post-discharge health care needs of patients after lung cancer resection. J Clin Nurs. 2010 Sep;19(17-18):2471-80. doi: 10.1111/j.1365-2702.2010.03298.x.

    PMID: 20920075BACKGROUND

  • Bartels K, Mayes LM, Dingmann C, Bullard KJ, Hopfer CJ, Binswanger IA. Opioid Use and Storage Patterns by Patients after Hospital Discharge following Surgery. PLoS One. 2016 Jan 29;11(1):e0147972. doi: 10.1371/journal.pone.0147972. eCollection 2016.

    PMID: 26824844BACKGROUND

  • Bisgaard T, Klarskov B, Rosenberg J, Kehlet H. Factors determining convalescence after uncomplicated laparoscopic cholecystectomy. Arch Surg. 2001 Aug;136(8):917-21. doi: 10.1001/archsurg.136.8.917.

    PMID: 11485527BACKGROUND

  • Luna IE, Kehlet H, Wede HR, Hoevsgaard SJ, Aasvang EK. Objectively measured early physical activity after total hip or knee arthroplasty. J Clin Monit Comput. 2019 Jun;33(3):509-522. doi: 10.1007/s10877-018-0185-5. Epub 2018 Jul 23.

    PMID: 30039461BACKGROUND

  • Aasvang EK, Luna IE, Kehlet H. Challenges in postdischarge function and recovery: the case of fast-track hip and knee arthroplasty. Br J Anaesth. 2015 Dec;115(6):861-6. doi: 10.1093/bja/aev257. Epub 2015 Jul 25.

    PMID: 26209853BACKGROUND

  • Timmerman JGJ, Dekker-van Weering MGHM, Wouters MWJMM, Stuiver MMM, de Kanter WW, Vollenbroek-Hutten MMRM. Physical behavior and associations with health outcomes in operable NSCLC patients: A prospective study. Lung Cancer. 2018 May;119:91-98. doi: 10.1016/j.lungcan.2018.03.006. Epub 2018 Mar 9.

    PMID: 29656759BACKGROUND

  • Wolvers MDJ, Bussmann JBJ, Bruggeman-Everts FZ, Boerema ST, van de Schoot R, Vollenbroek-Hutten MMR. Physical Behavior Profiles in Chronic Cancer-Related Fatigue. Int J Behav Med. 2018 Feb;25(1):30-37. doi: 10.1007/s12529-017-9670-3.

    PMID: 28699090BACKGROUND

MeSH Terms

Conditions

Lung NeoplasmsMotor ActivityPain, Postoperative

Condition Hierarchy (Ancestors)

Respiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SiteNeoplasmsLung DiseasesRespiratory Tract DiseasesBehaviorPostoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsPainNeurologic ManifestationsSigns and Symptoms

Study Officials

  • Lin Huang, MD

    Rigshospitalet, Denmark

    PRINCIPAL INVESTIGATOR

  • Henrik Kehlet, Professor, MD, DMSc

    Rigshospitalet, Denmark

    STUDY DIRECTOR

  • Rene H Petersen, Professor, MD, PhD

    Rigshospitalet, Denmark

    STUDY CHAIR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Medical Doctor, Research fellow, PhD student

Study Record Dates

First Submitted

July 31, 2020

First Posted

August 6, 2020

Study Start

September 15, 2020

Primary Completion

July 21, 2021

Study Completion

July 21, 2021

Last Updated

August 16, 2021

Record last verified: 2021-08

Locations

DK(1)