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NCT04506840Completed

Physical Activity and Motivation in Colorectal Cancer Patients

Development of an Educational and Motivational Program to Promote Adherence to Physical Activity and Its Positive Effects in Colorectal Cancer Patients

Source: ClinicalTrials.gov · Last updated 13 May 2024

Brief summary (registry, in English)

The intervention will be a physical exercise program for colorectal cancer patients during the adjuvant chemotherapy. The exercise program aims on reducing the side effects of the treatment and improving patients' quality of life. In addition, the investigators try to improve endurance and resistance training level, in order to achieve greater physical functionality, survival and general well-being. For this, the investigators will carry out an exercise program based mainly on muscular strength and cardiorespiratory condition. It will last 6 months, with a frequency of 3 days per week, including sessions of 60 minutes. Sessions will consist of three parts: warm-up, main part (endurance and resistance training), and cool down. An individualized and supervised progression of training will take place. The intensity levels will always be adjusted to the initial levels of the participants, always considering their preferences and comfort. Participants' preferences and exercise history will be considered through an initial interview. Motivational strategies based on self-determination theory will be applied, since it is one of the most used theories in the field of physical exercise. This theory proposes that all people need to feel competent, autonomous and socially related. If these three needs are satisfied, participants will develop more positive (autonomous) forms of motivation, which are related to better consequences such as vitality, enjoyment, quality of life and adherence to physical activity. In addition, motivational strategies will be applied for families and healthcare professionals. Before starting the program and at the end of it, each eligible patient will be evaluated through: * Physical activity: strength test of lower and upper limbs, agility test, stress test for cardiorespiratory fitness, physical activity levels, physical condition and body composition. * Psychological factors: autonomy support, basic psychological need satisfaction, motivation, quality of life, perceived barriers, depression, anxiety, hope, quality of life. * Clinical parameters: survival rate, side effects, biological factors, treatment delays and planned treatment completion.

Status (registry)
Completed
Study type
Interventional
Enrollment
32 (actual)
First submitted
21 Jul 2020
Start date
21 Jan 2020
Primary completion date
30 Jun 2023
Lead sponsor
Universidad Miguel Hernandez de Elche
NCT number
NCT04506840

What you commit to

  • Study type: Interventional
  • Participants enrolled: 32
  • From 21 Jan 2020 to the primary completion date, 30 Jun 2023
  • 2 sites in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Other illness

  • Colorectal cancer stage IV

Other

  • Have a disability
  • Presence of metastasis
  • Ecog \< 1

Who the study is looking for

  • Being more than 18 years
  • Colorectal cancer stage II and III
  • Be receiving adjuvant chemotherapy treatment after surgery
  • Ecog \> 1
  • No medical contraindications

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (2)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Universidad Miguel Hernández
Coordinator of this site? Confirm its status
ElcheSpainUnknown status
Hospital Universitario Puerta de Hierro
Coordinator of this site? Confirm its status
MadridSpainUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.