Exercise Program for Colorectal Older Patients

Study Overview
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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.

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.

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

Conditions
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Colorectal Neoplasms, Aged

Intervention / Treatment
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* Procedure: Enhanced Recovery After Surgery
* Behavioral: Home-based multicomponent exercise program (EXE)


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Control<br>Usual care (i.e., 'Enhanced Recovery After Surgery' (ERAS) protocol) | Procedure: Enhanced Recovery After Surgery<br>* ERAS protocol includes preoperative counselling, optimization of nutrition, standardized analgesic and anesthetic regimens and early mobilization.<br>* Other names: ERAS;|
| Experimental: Home-based multicomponent exercise program<br>Complete a home-based multicomponent exercise program from diagnosis to 3 months after surgery in addition to ERAS protocol. | Procedure: Enhanced Recovery After Surgery<br>* ERAS protocol includes preoperative counselling, optimization of nutrition, standardized analgesic and anesthetic regimens and early mobilization.<br>* Other names: ERAS;Behavioral: Home-based multicomponent exercise program (EXE)<br>* 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)<br>* Other names: EXE;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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. | 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 | 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 | 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) | 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. | 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) | 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. | within a 90 days postoperative time period | 
| Length of stay in hospital after colorectal surgery (days) | Duration in days | 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. | 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) | 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 | 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 | From baseline to 3 and 6 months after surgery | 
| Rate of mortality | All-cause mortality | From baseline to 6 month after surgery | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Cancer, Elderly, Exercise, Prehabilitation, Rehabilitation, Surgery, Colorectal, Physical activity