Exercise Program for Colorectal Older Patients

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

NA

Total Enrollment

252 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-04-08

Study Completion Date

2026-06-30

Brief Summary

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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.

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Detailed Description

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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

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Colorectal Neoplasms Aged

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Control

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

Group Type ACTIVE_COMPARATOR

Enhanced Recovery After Surgery

Intervention Type PROCEDURE

ERAS protocol includes preoperative counselling, optimization of nutrition, standardized analgesic and anesthetic regimens and early mobilization.

Home-based multicomponent exercise program

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

Group Type EXPERIMENTAL

Enhanced Recovery After Surgery

Intervention Type PROCEDURE

ERAS protocol includes preoperative counselling, optimization of nutrition, standardized analgesic and anesthetic regimens and early mobilization.

Home-based multicomponent exercise program (EXE)

Intervention Type BEHAVIORAL

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)

Interventions

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Enhanced Recovery After Surgery

ERAS protocol includes preoperative counselling, optimization of nutrition, standardized analgesic and anesthetic regimens and early mobilization.

Intervention Type PROCEDURE

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)

Intervention Type BEHAVIORAL

Other Intervention Names

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ERAS EXE

Eligibility Criteria

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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

Minimum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No