Exercise Program for Colorectal Older Patients
ECOOL
Effect of a Personalized Physical Exercise Program on Functional Capacity and Quality of Life in Older Colorectal Cancer Patients
1 other identifier
interventional
252
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Apr 2022
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 8, 2022
CompletedFirst Submitted
Initial submission to the registry
June 10, 2022
CompletedFirst Posted
Study publicly available on registry
July 7, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 30, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
June 30, 2026
January 8, 2026
January 1, 2026
4.2 years
June 10, 2022
January 7, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (4)
Change in Health-related Quality of Life (HRQoL) of cancer patients
HRQOL measured by the European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30). This questionnaire provides 0-100 scores in different single- or multi-item scales of three different domains of HRQoL: * Global health status (higher scores mean better health status) * Function (higher scores mean better function) * Symptomatology (higher scores mean worse symptomatology)
From baseline to 1 week, 3 months and 6 months after surgery
Change in supplementary HRQoL scales for colorectal cancer patients
The European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire for Colorectal Cancer 29 (EORTC QLQ-CR29) will be employed. This questionnaire consists of 4 multi-item scales and 19 single-items assessing a range of symptoms and problems common among patients with colorectal cancer. All of the scales and single-item measures range in score from 0 to 100. A high score for the functional scale and functional single-items represents a high level of functioning, whereas a high score for the symptom scales and symptom single-items represents a high level of symptomatology or problems.
From baseline to 1 week, 3 months and 6 months after surgery
Change in supplementary HRQOL scales for elderly cancer patients
The European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire for Elderly cancer patients (EORTC QLQ-ELD14) will be employed. The EORTC QLQ-ELD14 contains important age-specific issues for elderly cancer patients, which was developed to supplement the EORTC QLQ-C30. The QLQ-ELD14 comprises 14 items, made up of 5 scales (mobility, worries about others, future worries, maintaining purpose and burden of illness) and 2 single items (joint stiffness and family support). Scores in all areas range from 0 to 100, with higher scores indicating worse QoL in the case of mobility, joint stiffness, worries about others, future worries, and burden of illness, and better QoL in family support (feel able to talk to the family about the illness) and maintaining purpose.
From baseline to 1 week, 3 months and 6 months after surgery
Change in functional capacity
Change in functional status measured by Barthel Index. This index measures the extent to which somebody can function independently and has mobility in their activities of daily living (ADL). Including: feeding, bathing, grooming, dressing, bowel control, bladder control, toileting, chair transfer, ambulation and stair climbing. Scoring 0 points would be dependent in all assessed activities of daily living, whereas a score of 100 would reflect independence in these activities. Low scores on individual items highlight areas of need.
From baseline to 1 week, 3 months and 6 months after surgery
Secondary Outcomes (14)
Change in physical function
From baseline to admission for surgery and at 1, 3 and 6 months after surgery
Change in frailty status
From baseline to admission for surgery and at 1, 3 and 6 months after surgery
Change in upper limb muscle size (thickness, mm)
From baseline to admission for surgery and at 1, 3 and 6 months after surgery
Change in lower limb muscle size (thickness, mm)
From baseline to admission for surgery and at 1, 3 and 6 months after surgery
Change in inspiratory muscle function
From baseline to admission for surgery and at 1, 3 and 6 months after surgery
- +9 more secondary outcomes
Other Outcomes (6)
Number of pre-operative comorbidities
Baseline
Pre-operative physical status classification
Baseline
Number of pre-operative geriatric syndromes
Baseline
- +3 more other outcomes
Study Arms (2)
Control
ACTIVE COMPARATORUsual care (i.e., 'Enhanced Recovery After Surgery' (ERAS) protocol)
Home-based multicomponent exercise program
EXPERIMENTALComplete a home-based multicomponent exercise program from diagnosis to 3 months after surgery in addition to ERAS protocol.
Interventions
ERAS protocol includes preoperative counselling, optimization of nutrition, standardized analgesic and anesthetic regimens and early mobilization.
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)
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- Patients finally excluded for colorectal surgery.
- Patients with absolute contraindications to exercise
- Walk disability (FAC \<2)
- Severe cognitive impairment (MMSE \<18)
- Terminal illness
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Hospital general Universitario Gregorio Marañón
Madrid, Madrid, 28007, Spain
Related Publications (1)
Macias-Valle A, Rodriguez-Lopez C, Gonzalez-Senac NM, Mayordomo-Cava J, Vidan MT, Cruz-Arnes ML, Jimenez-Gomez LM, Dujovne-Lindenbaum P, Perez-Menendez ME, Ortiz-Alonso J, Valenzuela PL, Rodriguez-Romo G, Serra-Rexach JA. Exercise effects on functional capacity and quality of life in older patients with colorectal cancer: study protocol for the ECOOL randomized controlled trial. BMC Geriatr. 2023 May 22;23(1):314. doi: 10.1186/s12877-023-04026-6.
PMID: 37211611DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Jose Antonio Serra-Rexach, PhD, MD
HGU Gregorio Marañon
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Head Of Geriatry Department
Study Record Dates
First Submitted
June 10, 2022
First Posted
July 7, 2022
Study Start
April 8, 2022
Primary Completion (Estimated)
June 30, 2026
Study Completion (Estimated)
June 30, 2026
Last Updated
January 8, 2026
Record last verified: 2026-01
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, ICF
- Time Frame
- Data will be available from 3 months to 5 years following article publication.
- Access Criteria
- Data will be shared only to Investigators whose proposed use of the data has been approved by an independent review committee ("learned intermediary") identified for this purpose. Proposals should be directed to joseantonio.serra@salud.madrid.org. To gain access, data requestors will need to sign a data access agreement.
All of the individual participant data collected during the trial will be shared after deidentification. The disclosure of individual patient data must be in compliance with the provisions of the Organic Law on Data Protection and Digital Rights of the Government of Spain (Ley Orgánica 3/2018, de 5 de diciembre, de Protección de Datos Personales y garantía de los derechos digitales).