Exercise Program for Colorectal Older Patients

Browse trials for

• Colorectal Neoplasms 5,584
• Neoplasms 9,331
• Motor Activity 2,374

Keywords

• Cancer
• Elderly
• Exercise
• Prehabilitation
• Rehabilitation
• Surgery
• Colorectal
• Physical activity

Study arms

• Active comparator
  Control

  Usual care (i.e., 'Enhanced Recovery After Surgery' (ERAS) protocol)

  Procedure: Enhanced Recovery After Surgery

• Experimental
  Home-based multicomponent exercise program

  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)

Interventions

• ProcedureEnhanced Recovery After Surgery

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

  Also known as: ERAS

• BehavioralHome-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)

  Also known as: EXE

Primary outcomes

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)

   Time frame: 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.

   Time frame: 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.

   Time frame: 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.

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

Secondary outcomes

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.

   Time frame: 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.

   Time frame: 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

   Time frame: 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

   Time frame: 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)

   Time frame: 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.

   Time frame: 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)

   Time frame: 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.

   Time frame: within a 90 days postoperative time period

9. 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.

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.

    Time frame: 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)

    Time frame: 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

    Time frame: 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

    Time frame: From baseline to 3 and 6 months after surgery

14. Rate of mortality

    All-cause mortality

    Time frame: From baseline to 6 month after surgery

Other outcomes

1. Number of pre-operative comorbidities

   Charlson Comorbidity Index

   Time frame: Baseline

2. 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

3. Number of pre-operative geriatric syndromes

   Time frame: Baseline

4. 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

5. Dose of adjuvant treatment

   Total dose of adjuvant treatment(s) received

   Time frame: From baseline to 6 months after colorectal surgery

6. Colorectal Surgery Procedure

   Type of colorectal surgery procedure (i.e., open surgery or laparoscopic)

   Time frame: Immediately after the colorectal surgery

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 ↗

Individual participant data

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, Icf