To examine the predictive value of daily physical activity (steps/day) (DPA) of lung cancer surgical patients, measured by a pedometer, on postoperative morbidity.To examine the relationship between the daily physical activity (pedometer-assessed…
ID
Source
Brief title
Condition
- Respiratory tract therapeutic procedures
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
This study will use following parameters: daily physical activity (steps/day)
(DPA) and postoperative complications/morbidity.
Secondary outcome
Age (years)
Sexe
Pulmonary function in FEV1
Size of operation (lobectomy, bi-lobectomy or pneumectomy)
Type of lung malignancy (squamous cell carcinoma, adenocarcinoma, large cell
carcinoma)
Co-morbidity (Charlson scale, Charlson et al., 1987)
Performance score ECOG (Oken et al, 1982, Karnofsky)
Physical capacity in METs (from SQUASH test)
Physical capacity in METs (from questionnaire anesthetist)
Background summary
Operations in the thorax or upper abdomen, like lung resection surgery in
patients with localized non-small cell lung cancer (NSCLC) (stages I, II and
IIIA), are high-risk surgeries (Wiener-Kronish et al. 2005).
During the last two decades, better preoperative cardiopulmonary evaluation and
postoperative management have led to a decline in complications and
postoperative mortality of lung resection surgery patients (Perrot et al.,
1999). However, as a result of the increased proportion of older patients (>=70
years), the incidence of associated co-morbidity has increased during this
period (Morandi et al., 1996). Consequently this change in patient
characteristics results in an increased importance of the preoperative risk
estimation.
Study objective
To examine the predictive value of daily physical activity (steps/day) (DPA) of
lung cancer surgical patients, measured by a pedometer, on postoperative
morbidity.
To examine the relationship between the daily physical activity
(pedometer-assessed ambulatory activity) and the metabolic equivalent (MET)
levels of lung cancer surgical patients, obtained by questionnaires of the
anesthetist.
Study design
Psychometric study to the predictive validity of a risk screening instrument.
A correlation analysis and ROC curve analysis of performance based daily
physical activity monitoring (steps/day) and regular preoperative anaesthetic
screening (MET score) related to postoperative complications will be performed.
A survival analysis (Cox regression) will be used to examine the predictive
validity of DPAM (Daily Physical Activity Monitoring) and RPAS (Regular
Preoperative Anesthetic Screening by using METs scores) .
A logistic regression analysis of addition of the factor daily physical
activity (DPA) to the preoperative anaesthetic screening and the effect of
these factors plus DPA on the postoperative morbidity was also carried out.
The study will take eightteen months. The patient will participate two weeks
before surgery and 14 days after surgery his postoperative complication status
will be seen.
Study burden and risks
The extent of the burden is minimal. The participants fill in a short
questionnaire. This will take 15 minutes. In addition, the patients will wear a
pedometer for maximal 14 days.
Hanzeplein 1
9700 BR Groningen
Nederland
Hanzeplein 1
9700 BR Groningen
Nederland
Listed location countries
Age
Inclusion criteria
Willingness to comply with the research protocol
Non-Small Cell Lung Cancer (NSCLC) patient in the UMCG receiving lung resection surgery within ±7 days
Ambulatory (not bedridden)
Diagnosis of TNM stages I and II
Exclusion criteria
Use of wheelchair
Significant co-morbidity interfering with (daily) physical activity
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL18464.042.07 |