Rehabilitation for Thoracoscopic Lobectomy

August 13, 2021 updated by: Lin Huang, Rigshospitalet, Denmark

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

32

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Denmark
      • Copenhagen, Denmark
        • Rigshospitalet

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

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

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Pilot group
As a pilot Group for observating variable rehabilitation under individual baselines.
Device: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Through study completion, minimum 7 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Quality of recovery
Time Frame: Through study completion, an average of 14 days
The translation of the Danish version of the postoperative quality of recovery scale QoR-15D is used to evaluate the quality of care.
Through study completion, an average of 14 days
The quantization of fatigue
Time Frame: Through study completion, an average of 14 days
The Christensen Fatigue Scale (ChrFS) will be utilized to evaluate the degree of fatigue.
Through study completion, an average of 14 days
The quantization of pain
Time Frame: Through study completion, an average of 14 days
The numeric rating scale (NRS) ranging from 0 (no pain) to 10 (excruciating pain) is used to score postoperative pain.
Through study completion, an average of 14 days
The quantization of vomiting.
Time Frame: Through study completion, an average of 14 days
The numeric rating scale (NRS) ranging from 0 (nothing) to 10 (worest) is used to score postoperative vomiting.
Through study completion, an average of 14 days
The quantization of nausea.
Time Frame: Through study completion, an average of 14 days
The numeric rating scale (NRS) ranging from 0 (nothing) to 10 (worest) is used to score postoperative nausea.
Through study completion, an average of 14 days
The quantization of Activity Counts
Time Frame: Through study completion, an average of 14 days
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.
Through study completion, an average of 14 days
Length of sleep time
Time Frame: Through study completion, an average of 14 days
Investigators will use devices to record the specific sleep time for patients.
Through study completion, an average of 14 days
The quantization of morbidity
Time Frame: up to 30 days
The Clavien-Dindo Classification (CDC) is applied as a standard to grade the morbidity in 30 days after surgery.
up to 30 days
The quantization of mortality
Time Frame: up to 30 days
Investigators will investigate whether patients will experience unexpected death in 30 days after surgery
up to 30 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Rigshospitalet, Denmark

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

September 15, 2020

Primary Completion (ACTUAL)

July 21, 2021

Study Completion (ACTUAL)

July 21, 2021

Study Registration Dates

First Submitted

July 31, 2020

First Submitted That Met QC Criteria

August 4, 2020

First Posted (ACTUAL)

August 6, 2020

Study Record Updates

Last Update Posted (ACTUAL)

August 16, 2021

Last Update Submitted That Met QC Criteria

August 13, 2021

Last Verified

August 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • H-20041489

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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