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Completed

NCT Number: NCT04502654

Rehabilitation for Thoracoscopic 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.

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Key information

Conditions

Lung Neoplasms Behavior Exercise Lung Diseases Motor Activity Neoplasms Neoplasms by Site Neurologic Manifestations Pain Pain, Postoperative Pathologic Processes Pathological Conditions, Signs and Symptoms Post Discharge Postoperative Complications Rehabilitation Respiratory Tract Diseases Respiratory Tract Neoplasms Signs and Symptoms Thoracic Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Rigshospitalet

Copenhagen, Denmark

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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.

  7. 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.

  8. 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.

  9. The quantization of mortality

    Time frame: up to 30 days

    Investigators will investigate whether patients will experience unexpected death in 30 days after surgery

Sponsors and collaborators

Lead sponsor

Rigshospitalet, Denmark

Other

Registry information

Official study title

Postoperative Functional Recovery After Fast-track VATS Lobectomy

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Aug 6, 2020
Registry last updated
Aug 16, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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