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Colorectal NeoplasmsECOOLNCT05448846

Exercise Program for Colorectal Older Patients

A study testing Enhanced Recovery After Surgery and Home-based multicomponent exercise program (EXE) in people with Colorectal Neoplasms and Aged, run by Hospital General Universitario Gregorio Marañon at 1 site in Spain.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 75 years and older
Conditions the study is for
Colorectal Neoplasms, Aged
What is being tested?
Enhanced Recovery After Surgery and Home-based multicomponent exercise program (EXE)
Could I receive a placebo?
No, everyone receives an active treatment
How many people
252 participants
Where
1 siteSpain
Study dates
8 Apr 2022to 30 Jun 2026
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 75 years and older
  • All sexes
  • No healthy volunteers
  • Older adult

Who may be able to join

  • 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.

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

Spain1 site

  • Hospital general Universitario Gregorio Marañón

    Madrid, Madrid, 28007

Other trials in Spain

About this study

Official title: Effect of a Personalized Physical Exercise Program on Functional Capacity and Quality of Life in Older Colorectal Cancer Patients

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.

Read the 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.

Being tested
Enhanced Recovery After Surgery, Home-based multicomponent exercise program (EXE)
Keywords
Cancer, Elderly, Exercise, Prehabilitation, Rehabilitation, Surgery, Colorectal, Physical activity
Medical subject headings
Colorectal Neoplasms, Neoplasms, Motor Activity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Enhanced Recovery After SurgeryProcedure or surgery

    Also called ERAS

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

  • Home-based multicomponent exercise program (EXE)Behavioural

    Also called EXE

    Home-based multicomponent exercise program:

    1. 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.
    1. Gait (at least 30 minutes at an intensity that allows for comfortable conversation, 2 days/week on separate days from strength and balance exercise)
    2. Inspiratory Muscle Training: 30 inspirations at 40% of maximal inspiratory pressure through a Power Breathe device, 2 times per day)
Study groups in NCT05448846
Study groupRoleWhat they receive
ControlActive comparatorUsual care (i.e., 'Enhanced Recovery After Surgery' (ERAS) protocol)
Receives: Procedure: Enhanced Recovery After Surgery
Home-based multicomponent exercise programExperimentalComplete a home-based multicomponent exercise program from diagnosis to 3 months after surgery in addition to ERAS protocol.
Receives: Procedure: Enhanced Recovery After Surgery; Behavioral: Home-based multicomponent exercise program (EXE)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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)

    Measured: From baseline to 1 week, 3 months and 6 months after surgery

  2. 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.

    Measured: From baseline to 1 week, 3 months and 6 months after surgery

  3. 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.

    Measured: From baseline to 1 week, 3 months and 6 months after surgery

  4. 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.

    Measured: From baseline to 1 week, 3 months and 6 months after surgery

Secondary outcomes (14)

  1. 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.

    Measured: From baseline to admission for surgery and at 1, 3 and 6 months after surgery

  2. 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.

    Measured: From baseline to admission for surgery and at 1, 3 and 6 months after surgery

  3. Change in upper limb muscle size (thickness, mm)

    Ultrasound-based determination of biceps brachialis muscle thickness

    Measured: From baseline to admission for surgery and at 1, 3 and 6 months after surgery

  4. Change in lower limb muscle size (thickness, mm)

    Ultrasound-based determination of rectus femoris muscle thickness

    Measured: From baseline to admission for surgery and at 1, 3 and 6 months after surgery

  5. 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)

    Measured: From baseline to admission for surgery and at 1, 3 and 6 months after surgery

  6. 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.

    Measured: From baseline to admission for surgery and at 1, 3 and 6 months after surgery

  7. 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)

    Measured: From baseline to admission for surgery and at 1, 3 and 6 months after surgery

  8. 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.

    Measured: within a 90 days postoperative time period

  9. Length of stay in hospital after colorectal surgery (days)

    Duration in days

    Measured: From hospital admission for colorectal surgery up to discharge after surgery assessed up to 12 months.

  10. 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.

    Measured: At baseline and at 1, 3 and 6 months after surgery

  11. Prevalence of cancer-cachexia

    Prevalence of cancer-cachexia measured by the definition and classification of cancer cachexia: An international consensus (Fearon et al. 2012)

    Measured: At baseline and at 1, 3 and 6 months after surgery

  12. Prevalence of sarcopenia

    Prevalence of sarcopenia defined by the 'European Working Group on Sarcopenia in Older People 2' criteria

    Measured: At baseline and at 1, 3 and 6 months after surgery

  13. Number of hospital readmissions

    Number and mean length of hospital readmissions during the follow-up

    Measured: From baseline to 3 and 6 months after surgery

  14. Rate of mortality

    All-cause mortality

    Measured: From baseline to 6 month after surgery

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted7 Jul 2022
  2. Study start8 Apr 2022
  3. Primary completion30 Jun 2026 (estimated)
  4. Study completion30 Jun 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Supportive care
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
252 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05448846
Sponsor's protocol ID
PI21/01729
Acronym
ECOOL
Status last verified
Jan 2026
First submitted
10 Jun 2022
Last updated
8 Jan 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
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).

Publications

  • 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.

    PubMed 37211611

Questions about this trial

What is this clinical trial studying?

A study testing Enhanced Recovery After Surgery and Home-based multicomponent exercise program (EXE) in people with Colorectal Neoplasms and Aged, run by Hospital General Universitario Gregorio Marañon at 1 site in Spain.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 8 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in Health-related Quality of Life (HRQoL) of cancer patients (time frame: From baseline to 1 week, 3 months and 6 months after surgery). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05448846, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jan 2026.

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