Clinical trial NCT05448846: Exercise Program for Colorectal Older Patients
Official title: Effect of a Personalized Physical Exercise Program on Functional Capacity and Quality of Life in Older Colorectal Cancer Patients
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Colorectal Neoplasms
Aged
Keywords: Cancer
Elderly
Exercise
Prehabilitation
Rehabilitation
Surgery
Colorectal
Physical activity
Lead sponsor: Hospital General Universitario Gregorio Marañon
Sponsor class: OTHER
Collaborators: name: Instituto de Salud Carlos III
First posted: 2022-07-07
Enrollment: 252
Sex: ALL
Minimum age (years): 75
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief 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.

Eligibility criteria: 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

Primary outcomes:
measure: Change in Health-related Quality of Life (HRQoL) of cancer patients
timeFrame: From baseline to 1 week, 3 months and 6 months after surgery
measure: Change in supplementary HRQoL scales for colorectal cancer patients
timeFrame: From baseline to 1 week, 3 months and 6 months after surgery
measure: Change in supplementary HRQOL scales for elderly cancer patients
timeFrame: From baseline to 1 week, 3 months and 6 months after surgery
measure: Change in functional capacity
timeFrame: From baseline to 1 week, 3 months and 6 months after surgery
Secondary outcomes:
measure: Change in physical function
timeFrame: From baseline to admission for surgery and at 1, 3 and 6 months after surgery
measure: Change in frailty status
timeFrame: From baseline to admission for surgery and at 1, 3 and 6 months after surgery
measure: Change in upper limb muscle size (thickness, mm)
timeFrame: From baseline to admission for surgery and at 1, 3 and 6 months after surgery
measure: Change in lower limb muscle size (thickness, mm)
timeFrame: From baseline to admission for surgery and at 1, 3 and 6 months after surgery
measure: Change in inspiratory muscle function
timeFrame: From baseline to admission for surgery and at 1, 3 and 6 months after surgery
measure: Change in physical fitness
timeFrame: From baseline to admission for surgery and at 1, 3 and 6 months after surgery
measure: Change in physical activity
timeFrame: From baseline to admission for surgery and at 1, 3 and 6 months after surgery
measure: Comprehensive Complication Index (CCI)
timeFrame: within a 90 days postoperative time period
measure: Length of stay in hospital after colorectal surgery (days)
timeFrame: From hospital admission for colorectal surgery up to discharge after surgery assessed up to 12 months.
measure: Prevalence of Anxiety and Depression
timeFrame: At baseline and at 1, 3 and 6 months after surgery
measure: Prevalence of cancer-cachexia
timeFrame: At baseline and at 1, 3 and 6 months after surgery
measure: Prevalence of sarcopenia
timeFrame: At baseline and at 1, 3 and 6 months after surgery
measure: Number of hospital readmissions
timeFrame: From baseline to 3 and 6 months after surgery
measure: Rate of mortality
timeFrame: From baseline to 6 month after surgery
Other outcomes:
measure: Number of pre-operative comorbidities
timeFrame: Baseline
measure: Pre-operative physical status classification
timeFrame: Baseline
measure: Number of pre-operative geriatric syndromes
timeFrame: Baseline
measure: Type of adjuvant treatment
timeFrame: From baseline to 6 months after colorectal surgery
measure: Dose of adjuvant treatment
timeFrame: From baseline to 6 months after colorectal surgery
measure: Colorectal Surgery Procedure
timeFrame: Immediately after the colorectal surgery
Locations:
city: Madrid
country: Spain
facility: Hospital general Universitario Gregorio Marañón
Study officials:
affiliation: HGU Gregorio Marañon
name: Jose Antonio Serra-Rexach, PhD, MD
role: PRINCIPAL_INVESTIGATOR
References: