CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 32 enrolled
Drug / intervention
Physical activityother
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04506840
NCT04506840N/ACompleted

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

Universidad Miguel Hernandez de Elche·interventional·Posted Aug 10, 2020·Updated May 13, 2024

In Brief

A clinical study evaluating Physical activity for Quality of Life and 4 related conditions. Completed, enrolled 32 participants across 2 sites.

Detailed Summary

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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesSpain

Timeline

N/ACompletedFinished
2020202120222023202420252026
First PostedAug 10, 2020
Enrollment StartJan 21, 2020
Primary CompletionJun 30, 2023
Study CompletionDec 30, 2023
TodayJul 2, 2026
Enrollment to primary: 3.4 yearsPosted 5.9 years ago

Interventions

Physical activityother

Patients will participate in a program of physical exercise. Resistance training, endurance training, balance and flexibility will be trained with the objective to reduce the side effects of chemotherapy and, in order to improve their quality of life