NCT05448846

Exercise Program for Colorectal Older Patients

Effect of a Personalized Physical Exercise Program on Functional Capacity and Quality of Life in Older Colorectal Cancer Patients

• Status: Active Not Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 252 (estimated)
• Sponsor: Hospital General Universitario Gregorio Marañon · Academic / Other
• Sex: All
• Age: 75 Years
• Healthy volunteers: Not accepted

Summary

The Exercise for COlorectal OLder patients (ECOOL program) is randomized controlled trial to assess the effects of an exercise program on physical function and health-related quality of life of patients 75 years and older with colorectal cancer undergoing surgery. ECOOL is a multicomponent home-based exercise intervention focused on the development of strength, balance, gait ability and inspiratory muscle function of older patients who receive weekly telephone follow-up from cancer diagnosis to 3 months after surgery. The investigators expect that ECOOL program will improve physical function and health-related quality of life of older patients 3 months after surgery and to maintain these benefits up to 6 months after surgery compared with the control group receiving usual care.

Detailed description

Colorectal cancer (CRC) is the second most common cancer and the second cause of cancer-related death in Europe. Thirty-one percent of new cases are older than 74 years. The decrease in reserve capacity (i.e., frailty), comorbidity and the surgical treatment imply that the elderly patient is at greater risk of functional decline (reported between 15% and 18% three months after surgery).Up to 50% of those who have experienced functional decline do not recover previous levels of functional independence. The aim of this research is to investigate the effects of a multicomponent physical exercise program on physical function and health-related quality of life (HRQoL) of patients 75 years and older with CRC undergoing surgery. The exercise program focuses on the development of strength, balance, gait ability and inspiratory muscle function of older patients who receive weekly telephone follow-up from cancer diagnosis to 3 months after surgery. Weekly telephone follow-up is provided by an exercise specialist who monitors adherence to the exercise program and insists on its compliance, clarifies any doubt and prescribes exercise progression. Moreover, patients complete a supervised exercise session at baseline, during hospitalization and one month after surgery to ensure correct exercise execution and provide feedback. The investigators expect that ECOOL program will improve physical function and HRQoL of older patients 3 months after surgery and to maintain these benefits up to 6 months after surgery compared with the control group receiving usual care.

Conditions

• Colorectal Neoplasms
• Aged

Interventions

Type	Name	Description
PROCEDURE	Enhanced Recovery After Surgery	ERAS protocol includes preoperative counselling, optimization of nutrition, standardized analgesic and anesthetic regimens and early mobilization.
BEHAVIORAL	Home-based multicomponent exercise program (EXE)	Home-based multicomponent exercise program: A) Strength and balance (20 to 40 minutes, 2 days/week): * Chair sit to stand exercise \| 1 to 3 sets completing repetitions until rating 5 to 8 in the Rated of Perceived Exertion, 0-10 scale (RPE). * Seated curl to press exercise \| 1 to 3 sets completing repetitions until rating 5 to 8 RPE. * Monopodal balance \| 1 to 3 sets with progressive time targets up to 60-second for each leg. B) Gait (at least 30 minutes at an intensity that allows for comfortable conversation, 2 days/week on separate days from strength and balance exercise) C) Inspiratory Muscle Training: 30 inspirations at 40% of maximal inspiratory pressure through a Power Breathe device, 2 times per day)

Timeline

• Start date: 2022-04-08
• Primary completion: 2026-06-30
• Completion: 2026-06-30
• First posted: 2022-07-07
• Last updated: 2026-01-08

Locations

1 site across 1 country: Spain