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Rehabilitation for Thoracoscopic Lobectomy

Postoperative Functional Recovery After Fast-track VATS Lobectomy

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04502654
Enrollment
32
Registered
2020-08-06
Start date
2020-09-15
Completion date
2021-07-21
Last updated
2021-08-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Exercise, Lung Neoplasms, Pain, Postoperative, Post Discharge, Rehabilitation

Keywords

Functional recovery, Enhanced recovery after surgery, Video-assisted thoracoscopic surgery, Lobectomy

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.

Interventions

DEVICEActiwatch 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.

Sponsors

Rigshospitalet, Denmark
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Length of functional rehabilitationThrough study completion, minimum 7 daysInvestigators 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.

Secondary

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

Countries

Denmark

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026