Recruitment

Recruitment Status
Recruiting
Estimated Enrollment
Same as current

Summary

Conditions
  • Colorectal Cancer
  • Postoperative Complications
Type
Interventional
Phase
Not Applicable
Design
Allocation: RandomizedIntervention Model: Parallel AssignmentMasking: Single (Outcomes Assessor)Primary Purpose: Treatment

Participation Requirements

Age
Between 65 years and 125 years
Gender
Both males and females

Description

Reduced physical capacity and performance associated with advancing age may decrease the ability to withstand the strain of a major surgical intervention. Exercise prior to surgery is a key component of prehabilitation. The goal of prehabilitation is to enhance preoperative physical fitness to atten...

Reduced physical capacity and performance associated with advancing age may decrease the ability to withstand the strain of a major surgical intervention. Exercise prior to surgery is a key component of prehabilitation. The goal of prehabilitation is to enhance preoperative physical fitness to attenuate postoperative decline and possibly decrease the risk of postoperative complications. A previous observational study showed that better preoperative physical performance in measures of walking distance, leg strength, inspiratory muscle strength and maximal gait speed reduced the risk of severe postoperative complications for older patients undergoing abdominal cancer surgery. Furthermore, gait speed has been suggested to add information to current preoperative risk screening, where a cut of value of a maximal gait speed below 2 meters/second indicates a higher risk for postoperative complications. This planned trial will be conducted in cooperation with the Karolinska University Hospital, Ersta Hospital, The Stockholm South General Hospital and several primary care units in Stockholm. To target older patients at risk, patients aged 65 and older with a maximal gait speed under 2 meters/second will be included. Participants will be randomized to either intervention- or control group and trained physiotherapists or nurses from the hospitals, will conduct the assessments. All baseline measures will be collected before randomization. The implementation of standardized cancer care pathways in Sweden has led to reduced time between diagnosis to curative treatment. For colorectal surgery, the time from decision to treatment is set to two weeks. Therefore, an exercise program aimed to enhance physical function prior to surgery require a high intensity and high frequency approach. The exercise program will be home-based and consist of inspiratory muscle training, endurance- and strength exercise under the supervision of trained physiotherapists from primary care units. To assess feasibility of the planned intervention, a pilot study was conducted. The results showed high compliance and acceptability among the participants which provides a starting point for this larger study designed to explore the effects of preoperative exercise on: Preoperative physical function in a short-term perspective Postoperative complications and functional decline Length of in-hospital stay, mortality, health-related quality of life, physical activity level and independency in activities in daily living in a long-term perspective

Tracking Information

NCT #
NCT04878185
Collaborators
Not Provided
Investigators
Principal Investigator: Elisabeth Rydwik, Ass prof Karolinska Institutet