Rehabilitation for Thoracoscopic Lobectomy

Completed

• Conditions: Lung Neoplasms; Rehabilitation; Exercise; Post Discharge; Pain, Postoperative
• Interventions: Device: Actiwatch 2 (Philips Respironics, Murrysville, USA)

• Registration Number: NCT04502654
• Lead Sponsor: Rigshospitalet, Denmark

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-07-31
• Study First Submitted QC: 2020-08-04
• Study First Posted: 2020-08-06
• Study Start: 2020-09-15
• Primary Completion: 2021-07-21
• Study Completion: 2021-07-21
• Status Verified: 2021-08
• Last Update Submitted: 2021-08-13
• Last Update Posted: 2021-08-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 32

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Pilot group	Actiwatch 2 (Philips Respironics, Murrysville, USA)	As a pilot Group for observating variable rehabilitation under individual baselines.

Primary Outcome Measures

Name	Time	Method
Length of functional rehabilitation	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.

Secondary Outcome Measures

Name	Time	Method
Quality of recovery	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.
The quantization of fatigue	Through study completion, an average of 14 days	The Christensen Fatigue Scale (ChrFS) will be utilized to evaluate the degree of fatigue.
The quantization of pain	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.
The quantization of vomiting.	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.
The quantization of nausea.	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.
The quantization of Activity Counts	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.
Length of sleep time	Through study completion, an average of 14 days	Investigators will use devices to record the specific sleep time for patients.
The quantization of morbidity	up to 30 days	The Clavien-Dindo Classification (CDC) is applied as a standard to grade the morbidity in 30 days after surgery.
The quantization of mortality	up to 30 days	Investigators will investigate whether patients will experience unexpected death in 30 days after surgery

Trial Locations

Locations (1)

Rigshospitalet; 🇩🇰 Copenhagen, Denmark