Exercise Program for Colorectal Older Patients

Colorectal Neoplasms Clinical Trial

— ECOOL  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05448846
• Other study ID #: PI21/01729
• Status: Recruiting
• Phase: N/A
• Start date: April 8, 2022
• Est. completion date: December 2024

Study information

• Verified date: October 2023
• Source: Hospital General Universitario Gregorio Marañon
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 252
• Est. completion date: December 2024
• Est. primary completion date: December 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 75 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Aged
• Colorectal Neoplasms

Intervention

Procedure:
• Enhanced Recovery After Surgery
ERAS protocol includes preoperative counselling, optimization of nutrition, standardized analgesic and anesthetic regimens and early mobilization.

Behavioral:
• Home-based multicomponent exercise program (EXE)
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)

Locations

Country	Name	City	State
Spain	Hospital general Universitario Gregorio Marañón	Madrid

Sponsors (2)

Lead Sponsor	Collaborator
Hospital General Universitario Gregorio Marañon	Instituto de Salud Carlos III

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Number of pre-operative comorbidities	Charlson Comorbidity Index	Baseline
Other	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)	Baseline
Other	Number of pre-operative geriatric syndromes		Baseline
Other	Type of adjuvant treatment	Type of adjuvant treatment(s) received (ie., radiotherapy, chemotherapy or immunotherapy)	From baseline to 6 months after colorectal surgery
Other	Dose of adjuvant treatment	Total dose of adjuvant treatment(s) received	From baseline to 6 months after colorectal surgery
Other	Colorectal Surgery Procedure	Type of colorectal surgery procedure (i.e., open surgery or laparoscopic)	Immediately after the colorectal surgery
Primary	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
Primary	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
Primary	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
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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.
Secondary	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
Secondary	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
Secondary	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
Secondary	Number of hospital readmissions	Number and mean length of hospital readmissions during the follow-up	From baseline to 3 and 6 months after surgery
Secondary	Rate of mortality	All-cause mortality	From baseline to 6 month after surgery