Exercise Program for Colorectal Older Patients (ECOOL)

Hospital General Universitario Gregorio Marañon

Status: Active, not recruiting

Conditions: Colorectal Neoplasms; Aged

Treatments: Behavioral: Home-based multicomponent exercise program (EXE); Procedure: Enhanced Recovery After Surgery

Study type: Interventional

Funder types: Other

Identifiers

NCT05448846

PI21/01729

Details and patient eligibility

About

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.

Full 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.

Enrollment: 252 estimated patients

Sex: All

Ages: 75+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients aged 75 years or older diagnosed with colorectal cancer.
• Patients included in colorectal surgery waiting list of the Hospital General Universitario Gregorio Marañon (Madrid, Spain)
• Patients able to communicate, understand and sign the informed consent.

Exclusion criteria

• Patients finally excluded for colorectal surgery.
• Patients with absolute contraindications to exercise
• Walk disability (FAC <2)
• Severe cognitive impairment (MMSE <18)
• Terminal illness

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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252 participants in 2 patient groups

Control

Active Comparator group

Description:

Usual care (i.e., 'Enhanced Recovery After Surgery' (ERAS) protocol)

Treatment:

Procedure: Enhanced Recovery After Surgery

Home-based multicomponent exercise program

Experimental group

Description:

Complete a home-based multicomponent exercise program from diagnosis to 3 months after surgery in addition to ERAS protocol.

Treatment:

Procedure: Enhanced Recovery After Surgery

Behavioral: Home-based multicomponent exercise program (EXE)