Lung NeoplasmsNCT04502654

Rehabilitation for Thoracoscopic Lobectomy

An observational study of Lung Neoplasms and Rehabilitation, run by Copenhagen University Hospital, Rigshospitalet at 1 site in Denmark.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial 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. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Lung Neoplasms, Rehabilitation, Exercise
What is being tested?: Actiwatch 2 (Philips Respironics, Murrysville, USA)
Type of treatment: Medical device
How many people: 32 participants
Where: 1 siteDenmark
Study dates: 15 Sep 2020to 21 Jul 2021
Phase: Observational
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

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

Who may be able to join

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

Who cannot join

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.

Trial locations and contacts

1 site in 1 country.

Denmark1 site

Rigshospitalet
Copenhagen

Other trials in Denmark

About this study

Official title: Postoperative Functional Recovery After Fast-track VATS Lobectomy

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

Conditions: Lung Neoplasms, Rehabilitation, Exercise, Pain, Postoperative, Post Discharge
Being tested: Actiwatch 2 (Philips Respironics, Murrysville, USA)
Keywords: Functional recovery, Enhanced recovery after surgery, Video-assisted thoracoscopic surgery, Lobectomy
Medical subject headings: Lung Neoplasms, Motor Activity, Pain, Postoperative

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

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.

Study groups in NCT04502654
Study group	Role	What they receive
Pilot group		As a pilot Group for observating variable rehabilitation under individual baselines. Receives: Device: Actiwatch 2 (Philips Respironics, Murrysville, USA)

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: Through study completion, minimum 7 days

Secondary outcomes (9)

Quality of recovery
The translation of the Danish version of the postoperative quality of recovery scale QoR-15D is used to evaluate the quality of care.
Measured: Through study completion, an average of 14 days
The quantization of fatigue
The Christensen Fatigue Scale (ChrFS) will be utilized to evaluate the degree of fatigue.
Measured: Through study completion, an average of 14 days
The quantization of pain
The numeric rating scale (NRS) ranging from 0 (no pain) to 10 (excruciating pain) is used to score postoperative pain.
Measured: Through study completion, an average of 14 days
The quantization of vomiting.
The numeric rating scale (NRS) ranging from 0 (nothing) to 10 (worest) is used to score postoperative vomiting.
Measured: Through study completion, an average of 14 days
The quantization of nausea.
The numeric rating scale (NRS) ranging from 0 (nothing) to 10 (worest) is used to score postoperative nausea.
Measured: Through study completion, an average of 14 days
The quantization of Activity Counts
Investigators will use Electric Devices to record Activity Counts per day. Activity counts will be classified as sedentary behavior (SB) < 1303 counts/min (cpm), low intensity physical activity (LIPA) 1303 cpm - < 2588 cpm, and moderate to vigorous physical activity (MVPA) ≧2588 cpm.
Measured: Through study completion, an average of 14 days
Length of sleep time
Investigators will use devices to record the specific sleep time for patients.
Measured: Through study completion, an average of 14 days
The quantization of morbidity
The Clavien-Dindo Classification (CDC) is applied as a standard to grade the morbidity in 30 days after surgery.
Measured: up to 30 days
The quantization of mortality
Investigators will investigate whether patients will experience unexpected death in 30 days after surgery
Measured: up to 30 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

15 Sep 202021 Jul 2021

First posted6 Aug 2020
Study start15 Sep 2020
Primary completion21 Jul 2021
Study completion21 Jul 2021

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (15)Papers the sponsor has linked to this study.
Other trials for Lung NeoplasmsStudies 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: Observational
Observational model: Cohort
Time perspective: Prospective
Enrolment: 32 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04502654
Sponsor's protocol ID: H-20041489
Status last verified: Aug 2021
First submitted: 31 Jul 2020
Last updated: 16 Aug 2021
Results posted: No
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No

Publications

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.
PubMed 30207593
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.
PubMed 27160473
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.
PubMed 30946089
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.
PubMed 31157367
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.
PubMed 26324682
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.
PubMed 9175983
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.
PubMed 30304509
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.
PubMed 31903577
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.
PubMed 20920075
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.
PubMed 26824844
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.
PubMed 11485527
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.
PubMed 30039461
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.
PubMed 26209853
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.
PubMed 29656759
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.
PubMed 28699090

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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All Lung Neoplasms trials

Study at a glance

From the registry record, last updated by the sponsor on 16 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Postoperative Functional Recovery After Fast-track VATS Lobectomy
ClinicalTrials.gov ID: NCT04502654
Acronym / sponsor ID: H-20041489
Conditions: Lung Neoplasms, Rehabilitation, Exercise, Pain, Postoperative, Post Discharge
Keywords: Functional recovery, Enhanced recovery after surgery, Video-assisted thoracoscopic surgery, Lobectomy
Study type: Observational
Recruitment status: Completed
Enrolment: 32 participants (actual)
Lead sponsor: Copenhagen University Hospital, RigshospitaletUniversity, hospital or other
Study start: 15 Sep 2020 (actual)
Primary completion: 21 Jul 2021 (actual)
Study completion: 21 Jul 2021 (actual)
First posted: 6 Aug 2020 (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.

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

Study design

Observational model: Cohort
Time perspective: Prospective
Number of arms: 1

Arm	Type	Receives
Pilot group	–	Device: Actiwatch 2 (Philips Respironics, Murrysville, USA)As a pilot Group for observating variable rehabilitation under individual baselines.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult
Study population: Patients who will be submitted to video-assisted thoracoscopic surgery lobectomy.

Key inclusion criteria (3 listed)

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

Key exclusion criteria (5 listed)

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.

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
Actiwatch 2 (Philips Respironics, Murrysville, USA)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.	Device	Pilot group

Primary outcome

Length of functional rehabilitation
Time frame: Through study completion, minimum 7 days
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.

9 secondary outcomes

Quality of recovery
Time frame: Through study completion, an average of 14 days
The quantization of fatigue
Time frame: Through study completion, an average of 14 days
The quantization of pain
Time frame: Through study completion, an average of 14 days
The quantization of vomiting.
Time frame: Through study completion, an average of 14 days
The quantization of nausea.
Time frame: Through study completion, an average of 14 days
The quantization of Activity Counts
Time frame: Through study completion, an average of 14 days
Length of sleep time
Time frame: Through study completion, an average of 14 days
The quantization of morbidity
Time frame: up to 30 days
The quantization of mortality
Time frame: up to 30 days

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 16 Aug 2021.
Background: PubMed 30207593Bray 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.
Background: PubMed 27160473Bendixen 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.
Background: PubMed 30946089Yang 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.
Background: PubMed 31157367Marijic 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.
Background: PubMed 26324682Iwata 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.
Background: PubMed 9175983Kehlet 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.
Background: PubMed 30304509Batchelor 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.
Background: PubMed 31903577Kehlet H. Enhanced postoperative recovery: good from afar, but far from good? Anaesthesia. 2020 Jan;75 Suppl 1:e54-e61. doi: 10.1111/anae.14860.
Background: PubMed 20920075Wang 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.
Background: PubMed 26824844Bartels 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.
Background: PubMed 11485527Bisgaard 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.
Background: PubMed 30039461Luna 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.

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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.

Lin Huang, MD principal investigator

Copenhagen University Hospital, Rigshospitalet

Henrik Kehlet, Professor, MD, DMSc study director

Copenhagen University Hospital, Rigshospitalet

Rene H Petersen, Professor, MD, PhD study chair

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?

An observational study of Lung Neoplasms and Rehabilitation, 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 3 inclusion and 5 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: finished, as of the sponsor's last update on 16 Aug 2021. 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Length of functional rehabilitation (time frame: Through study completion, minimum 7 days). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04502654, which also lists 15 linked publications.

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 16 Aug 2021.