Clinical trial NCT03096951: Prehabilitation in Colorectal Cancer
Official title: Prehabilitation Before Surgery in Colorectal Cancer With Improved Fast Track Rehabilitation : Part 1
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Colon Cancer
Lead sponsor: Cliniques universitaires Saint-Luc- Université Catholique de Louvain
Sponsor class: OTHER
First posted: 2017-03-30
Enrollment: 28
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Objectives To investigate the impact of tele-supervised prehabilitation on functional capacity in colon cancer patients undergoing colorectal resection for cancer and to evaluate the effects of prehabilitation on muscle strength and endurance, quality of life (QoL), executive functions, fatigue and inflammatory and metabolic parameters.

Methods A randomized controlled trial will be conducted. Patients will be randomised into either a prehabilitation group or a control group. The prehabilitation group will receive tele-supervised prehabilitation for 4weeks and telerehabilitation for 8weeks post-surgery while control group will begin telerehabilitation only after surgery for 8weeks. Patients will care with an enhanced recovery pathway. Telerehabilitation pre and post-surgery will consist of three moderate-intensity aerobic and resistance sessions per week. Subjects will be assessed at baseline, pre-intervention, post-intervention and post-rehabilitation. The primary outcome will be functional capacity measured using the 6-min walk test. The secondary outcomes will be: physical measurement, quality of life, level of physical activity, executive functions, fatigue, body composition, blood test, energy expenditure.

Detailed description: Study objectives Primary objective: The investigators want to assess if a tele-supervised prehabilitation improves preoperative cardio-respiratory fitness in colon cancer patients in the setting of an enhanced recovery pathway.

Secondary objectives

* The investigators want to examine if this tele-supervised prehabilitation has beneficial effects on muscle strength and endurance, on quality of life, on executive functions, on fatigue, on inflammatory parameters and on metabolic disruption pre-surgery.
* The investigators want to determine whether changes in the preoperative period remain in the postoperative period after 8 weeks of telerehabilitation.

Rationale and scientific background:

In Belgium, colon cancer is the third most common cancer in men and the second most common in women and is the second cause of cancer death. Surgery is currently the primary treatment for stage I to III. This surgery benefits from several years of multimodal program, commonly called "Fast Track" program or enhanced recovery. Nowadays, the lack of preoperative fitness is not specifically taken into account in the Fast Track program. Nevertheless, studies have shown that patients with poor preoperative physical fitness are less able to cope with the adverse effects of surgery and hospitalization resulting in increased risk of mortality, postoperative complications and functional recovery time. It seems relevant to intervene during the preoperative period to improve the patient's functional capacity before the surgery, via physical training to overcome the stress of the surgery and to improve postoperative recovery. This process is called "prehabilitation" Structured and supervised programs have shown to be effective and feasible. However, time, resources, expensive care are often a barrier for the patient. Thereby, a home-based tele-supervising rehabilitation would be an attractive therapeutic option to offer a distinct advantage in this regard. More specifically, "telerehabilitation can be defined as the application of telecommunication, remote sensing and operation technologies, and computing technologies to assist with the provision of medical rehabilitation services at a distance".

Study design A single-blind, randomized, controlled trial will be conducted. Participants will be randomized into either a prehabilitation group or a rehabilitation group. Participants in both groups will care in an Fast Track Program. An assessor who will be blinded to group allocation will collect outcomes measures for each participant.

To be eligible for this study participants will need to meet the following criteria: Diagnosis of colon cancer requiring surgery; more than 50 years of age; autonomous and voluntary person; able to read, write and understand French; Participants will be excluded if the participants have a physical impairment that would seriously impair physical mobility; have an unfavorable familial context; have a stoma; have an American Society of Anesthesiologists score IV-V; the surgery is an emergency; have neuropsychiatric disease.

Participants allocated to the prehabilitation group will undertake a telerehabilitation program that will start 4 weeks before the surgery and will continue during 8 weeks after the surgery. Participants in the control group will receive World Health Organization recommendations on physical activity for health before surgery. After the surgery, The control group will undertake a telerehabilitation program over an 8-week period.

The telerehabilitation program will combine aerobic and resistance training three sessions per week. Each 60-min session will begin and end with a five-minute warm-up/cool. The warm-up will be followed by 25 minutes of aerobic training. Aerobic exercise can include brisk walking, jogging, cycling, or swimming according to patient's preference. The intensity of the exercise was set between 60 à 75% of maximum heart rate (maximal heart rate=220 - age). And between 12 and 16 on Borg's Rating of Perceived Exertion Scale. Each participant will wear a heart monitor. The aerobic training will be followed by resistance exercise performed on eight exercises targeting major muscle groups (abdominal, hamstring, quadriceps, triceps, gluteus maximus, paraspinal muscles and shoulder muscles). Intensity must be between 12 and 16 on the Borg's Rating of Perceived Exertion Scale. A physiotherapist will provide detailed information about the program. The patient will receive a brochure in which there will be descriptions and pictures of exercises and a video including the resistance program was recorded on a website. The researcher will conduct weekly telephone calls with the participants. The aim of these calls will be to solve any problems of carrying out the training sessions and to discuss about possible adverse events. Moreover, the researcher will give messages of support and encouragement to improve adherence to the program.

Outcome measures will be assessed at four time points: at baseline (T0), one day before the scheduled date of surgery (T1), one week after the intervention (T2) and at the end of the postoperative rehabilitation (T3).

Primary outcome will be cardiorespiratory fitness 6min walk test). Secondary outcomes will be muscle strength and endurance (isokinetic dynamometer and 1min sit-to-stand-test), quality of life ("Euroquol-5D-3L" questionnaire); level of physical activity (International Physical Activity Questionnaire Short Form); fatigue (Functional Assessment of Cancer Therapy: Fatigue); executive functions (Trail Making test, Stroop test and fluency) ; blood test (neutrophil lymphocyte ratio, C reactive protein, fasting glucose, fasting insulin and cholesterol will be measured by bioelectrical impedance analysis); energy expenditure ("Sensewear®" armband).

Eligibility criteria: Inclusion Criteria:

* Diagnosis of colon cancer requiring surgery;
* more than 40 years of age;
* autonomous and voluntary person;
* able to read, write and understand French;
* Frailty phenotype criteria \< 3

Exclusion Criteria:

* a physical impairment that would seriously impair physical mobility;
* an unfavorable familial context;
* a stoma;
* American Society of Anesthesiologists score IV-V;
* emergency;
* neuropsychiatric disease.

Primary outcomes:
measure: Change in cardiorespiratory fitness
timeFrame: Assessments at baseline, one day before the surgery, 1 week after the surgery and immediately after the rehabilitation
Secondary outcomes:
measure: Change in muscle strength
timeFrame: Assessments at baseline, one day before the surgery, immediately after the rehabilitation
measure: Change in muscle endurance
timeFrame: Assessments at baseline, one day before the surgery, 1week after the surgery and immediately after the rehabilitation
measure: Change in quality of life
timeFrame: Assessments at baseline, one day before the surgery, 1week after the surgery and immediately after the rehabilitation
measure: Change in fatigue
timeFrame: Assessments at baseline, one day before the surgery, 1week after the surgery and immediately after the rehabilitation
measure: Change in level of physical activity
timeFrame: Assessments at baseline, one day before the surgery, 1week after the surgery and immediately after the rehabilitation
measure: Change in executive functions
timeFrame: Assessments at baseline, one day before the surgery, 1 week after the surgery and immediately after the rehabilitation
measure: Change in executive functions
timeFrame: Assessments at baseline, one day before the surgery, 1 week after the surgery and immediately after the rehabilitation
measure: Change in weight
timeFrame: Assessments at baseline, one day before the surgery, 1 week after the surgery and immediately after the rehabilitation
measure: Change in lean body mass
timeFrame: Assessments at baseline, one day before the surgery, 1 week after the surgery and immediately after the rehabilitation
measure: Change in fat body mass
timeFrame: Assessments at baseline, one day before the surgery, 1 week after the surgery and immediately after the rehabilitation
measure: Energy expenditure
timeFrame: During 7 days before the surgery and during 7 days after the surgery
measure: Change in Fasting glucose
timeFrame: Assessments at baseline, one day before the surgery, 1 week after the surgery and immediately after the rehabilitation
measure: Change in Fasting insulin
timeFrame: Assessments at baseline, one day before the surgery, 1 week after the surgery and immediately after the rehabilitation
measure: Change in cholesterol
timeFrame: Assessments at baseline, one day before the surgery, 1 week after the surgery and immediately after the rehabilitation
measure: Change in neutrophil/lymphocyte
timeFrame: Assessments at baseline, one day before the surgery, 1 week after the surgery and immediately after the rehabilitation
measure: Change in C-reactive protein
timeFrame: Assessments at baseline, one day before the surgery, 1 week after the surgery and immediately after the rehabilitation
measure: Adherence
timeFrame: Assessments at baseline, one day before the surgery, 1 week after the surgery and immediately after the rehabilitation
Other outcomes:
Locations:
city: Brussels
country: Belgium
facility: Cliniques universitaires Saint-Luc
state: Woluwé-Saint-Lambert
Study officials:
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