High-Intensity Interval vs. Moderate Continuous Training in Surgical Prehabilitation.
Ontology highlight
ABSTRACT:
DISEASE(S): Colorectal Cancer,Colorectal Neoplasms
PROVIDER: 2260347 | ecrin-mdr-crc |
REPOSITORIES: ECRIN MDR
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Project description:Main objective: To evaluate the bidirectional relationships between physical exercise and sleep parameters, as a part of multimodal prehabilitation intervention, on pre- and postoperative outcomes in surgical patients with colorectal cancer, in an RCT.
Secondary objective: to determine whether the levels of anxiety and depression affect these relationships.
Objectives are based on the overarching hypothesis that is sleep and physical activity influence each other through complex, reciprocal interactions including multiple physiological and psychological pathways. To achieve this, providing a multimodal prehabilitation, specifically physical exercise, involved in mental and physical health through different mechanisms, i.e., improving physical functioning and fitness, reducing side effects of cancer treatments, preventing bone loss and weight gain, improving the quality of life and sleep, decreasing symptoms of fatigue and depression.
The present is a pilot study aiming to evaluate the bidirectional relationships between sleep and physical exercise, and the preliminary outcome has important implications for informing both clinical and public health practice.
Research question: Does a multimodal intervention including physical exercise improve sleep quality and duration compared to standard of care, during the perioperative period? Conversely, does a better sleep quality and duration increases the level of physical exercise during the perioperative period? How the level of anxiety and depression will affect these relationships? If the Prehabilitation program specifically physical exercise will positively affect sleep quality and duration after surgery, in the way to be a protective factor of sleep to not be reduced by up to 55% compared to those receiving standard of care?
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Project description:Interventions: Study setting-
The study will be conducted at the Surgical Professorial Unit of Colombo South Teaching Hospital.
Method of randomization-
• Following consent, participants will be randomized 1:1 using a random number table to the intervention group or control group with stratification by gender and age group.
•The research associate (who will be responsible for patient consent) will be blinded to group allocation.
Description of mindfulness based tromodal prehabilitation intervention
• The multidisciplinary Mindfulnes-Based trimodal prehabilitation program is composed of four (04) elements:
1. Exercise program
2. Nutritional intervention
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4. Mindfulness Protocol
• The exact interventions are described in detail below:
Exercise program
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• The exercise regime will comprise of 5 min warm-up exercises, 20 min aerobic exercises and 5 min cool down exercises.
• A personalized trainer will evaluate the patient and after discussing with the patient and their families will come up with an individualized exercise plan for the patients based on their physical capacity and resources.
• They will also be given a DVD containing videos of the exercises performed by a trained personal giving instruction to the patient to follow.
• Patients will be given a chart to fill once completing their exercise regime daily.
Nutrition intervention
• The patients enrolled in the prehabilitation program will be evaluated by a qualified nutritionist during the first visit, Aasubjective global assessment will be used to assess each patients’ nutritional status and requirements and an appropr
Primary outcome(s): Functional recovery using the Six-Minute Walk Test (6MWT, Pulse Rate (PR), Blood Pressure (BP) and Oxygen Saturation (SpO2) [1. At the start of the trial
2. Four weeks after prehabilitation or Before the surgery
3. 4-Weeks post-operatively
4. 8-Weeks post-operatively
]
Study Design: Randomized controlled trial
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