An interventional study of Enhanced Recovery After Surgery and Home-based multicomponent exercise program (EXE) in Colorectal Neoplasms and Aged, sponsored by Hospital General Universitario Gregorio Marañon. Active, not recruiting at 1 site in Spain. Open to participants aged 75 Years and older. Per ClinicalTrials.gov, last updated 2026-01-08.
Sponsored by Hospital General Universitario Gregorio Marañon · Not applicable, Interventional, and Supportive care
Among 461 studies in Colorectal Neoplasms with a site in Spain — 98 open to participants now, 150 under way, 18 of them phase 3. Colorectal Neoplasms · Spain.
Among the 461 studies in Colorectal Neoplasms with a site in Spain, this one is the 160th largest by planned enrollment of the 404 interventional ones that give a count, is one of 32 that started in 2022, is one of 61 with no phase, reaches primary completion later than 29 of the 149 other live ones, and was the 332nd registered.
6,541 studies on the registry are indexed under Colorectal Neoplasms; 1,667 are open to participants now.
Browse Colorectal Neoplasms studies →98 of the 461 studies in Colorectal Neoplasms with a site in Spain are open now. Recruiting first, the newest first:
Blueprint Medicines Corporation · Sites in Spain, United States
Maimónides Biomedical Research Institute of Córdoba · Sites in Spain
AbbVie · Sites in Spain, United States, Belgium and 7 more countries
Gilead Sciences · Sites in Spain, United States, Australia and 1 more country
Fundacion Clinic per a la Recerca Biomédica · Sites in Spain
A study can be open while its sites in Spain have not opened yet or have stopped. Only those recruiting at a site in Spain →
Of the 1,185 Colorectal Neoplasms studies recruiting now, 769 (65%) set no upper age limit and 265 (22%) stop at 75 or younger; 48 take children under 18; 123 take healthy volunteers.
This study: 75 Years and older · all sexes · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
461 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 146 · Phase 2 191 · Phase 3 73 · Phase 4 7
First in 1993; this study’s year is marked. 32 started in 2022.
By drug class, each counting the studies that test any of its medicines:
This study's planned enrollment of 252 is above the median of 76 across 4,800 interventional studies indexed under Colorectal Neoplasms.
Median enrollment 168 across the 404 interventional studies, 408 across the 54 observational. Of the 280 that completed or were terminated, 123 (44%) have results posted.
This tab as a report to print or save as PDF → With an account.
299 of 461 have an industry lead sponsor. The 10 most frequent:
Hospital General Universitario Gregorio Marañon is the lead sponsor of 60 studies on the registry; 7 are open to participants now.
Hospital General Universitario Gregorio Marañon has 1 study filed under Colorectal Neoplasms — fewer than ten, so there is no comparison to draw.
41 of the studies in Colorectal Neoplasms with a site in Spain that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT04486378BioNTech SEA Phase II Clinical Trial Comparing the Efficacy of RO7198457 Versus Watchful Waiting in Patients With ctDNA-positive, Resected Stage II (High Risk) and Stage III Colorectal Cancer | 2026-11 |
| NCT05988645MiWEndo Solutions S.L.Performance and Safety of MiWEndo-assisted Colonoscopy (MiWEndo II) | 2026-11-29 |
| NCT05789069HiFiBiO TherapeuticsA Study of HFB200603 as a Single Agent and in Combination With Tislelizumab in Adult Patients With Advanced Solid Tumors | 2026-12 |
| NCT06607458Delcath Systems Inc.Evaluation of the Safety and Efficacy of Treatment w/High Dose Melphalan Given Directly Into the Liver Followed by Treatment w/Approved Cancer Treatment or Approved Cancer Treatment Alone in Patients w/ Metastatic Colorectal Cancer w/Liver Dominant Disease | 2026-12 |
| NCT07151040One-carbon Therapeutics ABPhase 1/2 Study to Evaluate TH9619 in the Treatment of Advanced Solid Tumors | 2026-12 |
Among the 461 studies in Colorectal Neoplasms with a site in Spain, from their registry updates:
This tab as a report to print or save as PDF → With an account.
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.
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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Short tests of memory and thinking, each scored out of 30. Lower scores suggest more difficulty; criteria give a range, either to include people with memory problems or to leave them out.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
MMSE and MoCA
Short tests of memory and thinking, each scored out of 30. Lower scores suggest more difficulty; criteria give a range, either to include people with memory problems or to leave them out.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Usual care (i.e., 'Enhanced Recovery After Surgery' (ERAS) protocol)
Procedure: Enhanced Recovery After Surgery
Complete a home-based multicomponent exercise program from diagnosis to 3 months after surgery in addition to ERAS protocol.
Procedure: Enhanced Recovery After Surgery · Behavioral: Home-based multicomponent exercise program (EXE)
ERAS protocol includes preoperative counselling, optimization of nutrition, standardized analgesic and anesthetic regimens and early mobilization.
Also known as: ERAS
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)
Also known as: EXE
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)
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: From baseline to 1 week, 3 months and 6 months after surgery
Change in physical function
Changes in physical function measured by the Short Physical Performance Battery (SPPB). SPPB consists of 3 components: standing balance, gait speed, and repeated chair rise. Balance includes standing with feet side-by-side, semi-tandem, and tandem stance. Gait speed scores reflected the time needed to walk 4 m. Repeated chair rise is scored based on time to complete 5 chair rises. Each SPPB component is scored from 0 to 4, and the total sore ranged was 0-12 with higher scores indicating better function.
Time frame: From baseline to admission for surgery and at 1, 3 and 6 months after surgery
Change in frailty status
Changes in frailty status measured by the Fried's phenotype. This method classifies older adults as frail, pre-frail or non-frail based on five criteria: I) Weight loss (unintentionally), II) Exhaustion, III) Low physical activity, IV) Low habitual gait speed and V) Low handgrip strength.
Time frame: From baseline to admission for surgery and at 1, 3 and 6 months after surgery
Change in upper limb muscle size (thickness, mm)
Ultrasound-based determination of biceps brachialis muscle thickness
Time frame: From baseline to admission for surgery and at 1, 3 and 6 months after surgery
Change in lower limb muscle size (thickness, mm)
Ultrasound-based determination of rectus femoris muscle thickness
Time frame: From baseline to admission for surgery and at 1, 3 and 6 months after surgery
Change in inspiratory muscle function
Measurement of the maximum static inspiratory pressure (cm H2O) that a subject can generate at the mouth (PImax). This measure reflects the inspiratory muscle function (strength)
Time frame: From baseline to admission for surgery and at 1, 3 and 6 months after surgery
Change in physical fitness
Change in physical fitness evaluated through a modified version of the Senior Fitness Test (Rikli \& Jones, 2001) designed to assess different components of older adults physical fitness: * Upper and lower limbs muscle strength (30 seconds arm curl test and 30 second Sit to Stand tests, in number of repetitions) * Upper and lower limbs flexibility (Back Scratch test and Chair Sit and Reach test, centimeters) * Monopodal Static Balance (Flamingo test, in seconds) * Agility (8-foot Timed Up\&Go test, in seconds) * Maximal gait speed (30-meter maximal walking speed test, in meters per second) * Cardiorespiratory fitness (2-minute step test, in number of steps) The raw values obtained in each test will be expressed in specific normative values (percentiles) for the non-institutionalized Spanish elderly (Pedrero-Chamizo, 2012). Finally, a single measure of physical fitness will be reported by averaging the percentile values obtained for all test.
Time frame: From baseline to admission for surgery and at 1, 3 and 6 months after surgery
Change in physical activity
Change in physical activity evaluated through the Physical Activity Scale for Elderly (PASE).This questionnaire is comprised of self-reported occupational, household and leisure activities items over a one-week period that provides a global score ranged from 0 (no physical activity) to 400 or more (more physical activity)
Time frame: From baseline to admission for surgery and at 1, 3 and 6 months after surgery
Comprehensive Complication Index (CCI)
The Comprehensive Complication Index (CCI) is calculated as the sum of all Clavien-Dindo complications that are weighted for their severity. The final formula yields a continuous scale that ranks the cumulative burden from any combination of complications from 0 (no complication) to 100 (death) with higher values indicating a higher cumulative burden in a single patient.
Time frame: within a 90 days postoperative time period
Length of stay in hospital after colorectal surgery (days)
Duration in days
Time frame: From hospital admission for colorectal surgery up to discharge after surgery assessed up to 12 months.
Prevalence of Anxiety and Depression
Assessed by the Hospital Anxiety and Depression Scale (HADS). This scale consisted of 14 items that evaluate anxiety (7 items, 28 points) and depression (7 items, 28 points).For each mood disorder, scores greater than 10 are considered indicative of morbidity. A score of 8-10 is interpreted as borderline, and scores below 8 indicate no significant morbidity.
Time frame: At baseline and at 1, 3 and 6 months after surgery
Prevalence of cancer-cachexia
Prevalence of cancer-cachexia measured by the definition and classification of cancer cachexia: An international consensus (Fearon et al. 2012)
Time frame: At baseline and at 1, 3 and 6 months after surgery
Prevalence of sarcopenia
Prevalence of sarcopenia defined by the 'European Working Group on Sarcopenia in Older People 2' criteria
Time frame: At baseline and at 1, 3 and 6 months after surgery
Number of hospital readmissions
Number and mean length of hospital readmissions during the follow-up
Time frame: From baseline to 3 and 6 months after surgery
Rate of mortality
All-cause mortality
Time frame: From baseline to 6 month after surgery
Number of pre-operative comorbidities
Charlson Comorbidity Index
Time frame: Baseline
Pre-operative physical status classification
American Society of Anesthesiologists (ASA) physical status classification system. This scale consists of 6 different levels, from I (normal healthy patient) to VI (a declared brain-dead patient whose organs are being removed for donor purposes)
Time frame: Baseline
Number of pre-operative geriatric syndromes
Time frame: Baseline
Type of adjuvant treatment
Type of adjuvant treatment(s) received (ie., radiotherapy, chemotherapy or immunotherapy)
Time frame: From baseline to 6 months after colorectal surgery
Dose of adjuvant treatment
Total dose of adjuvant treatment(s) received
Time frame: From baseline to 6 months after colorectal surgery
Colorectal Surgery Procedure
Type of colorectal surgery procedure (i.e., open surgery or laparoscopic)
Time frame: Immediately after the colorectal surgery
Plan to share: Yes — 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).
Supporting information: Study protocol, Informed consent form
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.
Started Apr 2022 (actual). Primary completion is estimated for Jun 2026, 50 months after the start.
Of 898 non-industry interventional studies with no phase under Colorectal Neoplasms, half reached primary completion within 32 months of starting (the median), counting those still running; a quarter within 15 and three quarters within 62. This study's planned 50 months is above that.
Counting every sponsor, half of 955 studies reached it within 32 months; a quarter within 14 and three quarters within 60.
How these figures are worked out, and which studies are left out of them.
This study is active, not recruiting, as verified in Jan 2026. You cannot join it, but the record below documents what was studied.
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Hospital General Universitario Gregorio Marañon