Cette page a été traduite automatiquement et l'exactitude de la traduction n'est pas garantie. Veuillez vous référer au version anglaise pour un texte source.

Exercise for Adults Diagnosed With Rectal Cancer

6 mars 2020 mis à jour par: Jennifer Brunet, University of Ottawa

Exercise for Adults Diagnosed With Rectal Cancer: A Feasibility Study

Currently, there is no clear indication if exercise is safe and if it confers health benefits for adults across the cancer trajectory (i.e., from diagnosis onward) for rectal cancer - a population who may have limited exercise tolerance and who may be at an increased risk for adverse events associated with exercise. In this prospective single-arm feasibility trial, we aim to examine the safety and feasibility of a 12-week exercise intervention for adults diagnosed with rectal cancer to inform the development of a large-scale randomized controlled trial that will assess the efficacy of exercise administered across the cancer trajectory for for rectal cancer. Adults who have been diagnosed with rectal cancer and are currently undergoing or have completed treatment (within the last five years) will be recruited over a 12-month period into a supervised exercise intervention consisting of aerobic and strength training to be done three times per week. Feasibility, safety, patient-reported outcomes, and physical tests will be performed pre-intervention and post-intervention. This study will provide data on the feasibility of an exercise intervention and will help determine if it is safe to progress with a large-scale randomized controlled trial to test the benefits of exercise for adults diagnosed with rectal cancer. It will also provide initial estimates of the parameters for patient-reported outcomes, which are required to calculate the sample size for the large-scale randomized controlled trial to ensure it is sufficiently powered.

The purpose of this prospective single-arm feasibility trial is to determine if a 12-week exercise intervention offered to adults diagnosed with rectal cancer surviviors is safe and feasible.

The specific objectives are to:

  1. Test the feasibility and safety of a 12-week exercise intervention;
  2. Obtain initial estimates of the parameters of the main outcomes to inform sample size calculations for the main study (i.e., means and standard deviations for patient-reported and physical outcomes);
  3. Determine the opportune time in the cancer trajectory for rectal cancer to deliver a 12-week exercise intervention.

Aperçu de l'étude

Statut

Retiré

Les conditions

Intervention / Traitement

Type d'étude

Interventionnel

Phase

  • N'est pas applicable

Contacts et emplacements

Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.

Lieux d'étude

  • Canada
    • Ontario
      • Ottawa, Ontario, Canada, K1N 6N5
        • University of Ottawa

Critères de participation

Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.

Critère d'éligibilité

Âges éligibles pour étudier

18 ans à 85 ans (Adulte, Adulte plus âgé)

Accepte les volontaires sains

Non

Sexes éligibles pour l'étude

Tout

La description

Inclusion criteria are:

  1. Men and women 18 to 85 years of age;
  2. Diagnosed and/or completed treatment for stage I-III rectal cancer within the last 5 years;
  3. Able to read/understand English or French;
  4. Ambulatory;
  5. Live <50km of the University of Ottawa;
  6. Approval of healthcare provider to participate in the intervention.

Exclusion criteria are:

  1. Congestive heart failure, clinically significant aortic stenosis, history of cardiac arrest, use of a cardiac defibrillator, uncontrolled angina, uncontrolled arrhythmia, myocardial infarction, major heart surgery, stroke, or pulmonary embolus;
  2. A diagnosis of hypertension or a resting blood pressure of 160/90 mmHg or higher (i.e., systolic blood pressure ≥ 160 mmHg and/or diastolic blood pressure ≥ 90 mmHg);
  3. The use of supplemental oxygen;
  4. Severe arthritis (i.e., osteoarthritis or rheumatoid arthritis);
  5. History of chest pain or severe shortness of breath either at rest or when engaging in physical activity;
  6. Hip fracture, hip or knee replacement in the past 6 months;
  7. Impairments requiring mobility aids;
  8. Stage V cancer;
  9. Prior cancer diagnosis, excluding non-melanoma skin cancer;
  10. Participating in another exercise trial;
  11. Unwilling/unable to give informed consent.

Of note, in addition to the exclusion criteria listed above, for individuals who are about to begin or are undergoing treatment healthcare providers will also employ clinical judgment concerning participant safety; that is, if the healthcare provider judges the patient to be at high risk for adverse events or medical complications if they participate in the intervention given their health status, they will not approach the patient to obtain permission for research personnel from the University of Ottawa to contact them.

Plan d'étude

Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.

Comment l'étude est-elle conçue ?

Détails de conception

  • Objectif principal: Soins de soutien
  • Répartition: N / A
  • Modèle interventionnel: Affectation à un seul groupe
  • Masquage: Aucun (étiquette ouverte)

Armes et Interventions

Groupe de participants / Bras
Intervention / Traitement
Expérimental: Exercise
Participants will be asked to complete a 12-week exercise intervention and all study assessments.
Comportemental: Exercise
Participants will engage in supervised exercise 3 times per week for 60-75 minutes/session for 12 weeks. Sessions will include a warm-up (aerobic activity less than < 60% of heart rate reserve), aerobic training (30 minutes of exercise at 60-75% of heart rate reserve, using cycle ergometers/treadmills), strength training (8 exercises; upper body, lower body, and core), and a cool-down (aerobic activity less than < 60% of heart rate reserve) component.

Que mesure l'étude ?

Principaux critères de jugement

Mesure des résultats
Description de la mesure
Délai
Recruitment Rates
Délai: Through study completion, an average of 12 weeks
The number of eligible participants who enrol in the study out of the number who are referred.
Through study completion, an average of 12 weeks
Retention Rates
Délai: Through study completion, an average of 12 weeks
The number of participants completing the intervention and all scheduled assessments.
Through study completion, an average of 12 weeks
Adherence Rates
Délai: Through study completion, an average of 12 weeks
The number of exercise sessions completed out of 36.
Through study completion, an average of 12 weeks
Number of Participants with Adverse Events
Délai: Through study completion, an average of 12 weeks
The number of participants reporting or presenting adverse events (e.g., injury) that occurs as a result of participating in the exercise sessions and/or its assessments.
Through study completion, an average of 12 weeks

Autres mesures de résultats

Mesure des résultats
Description de la mesure
Délai
Socio-Demographic and Medical Information Questionnaire
Délai: Baseline (week 0)
The socio-demographic and medical information collected will be used to describe the sample.
Baseline (week 0)
Quality of Life: Functional Assessment of Cancer Therapy - Colorectal (Ward et al., 1999; Yost et al., 2005)
Délai: Baseline (week 0) and post-intervention (week 12)
Change in self-reported quality of life from baseline to post-intervention.
Baseline (week 0) and post-intervention (week 12)
Cognitive Functioning: Functional Assessment of Cancer Therapy - Cognitive Function (Wagner et al., 2004)
Délai: Baseline (week 0) and post-intervention (week 12)
Change in self-reported cognitive function from baseline to post-intervention.
Baseline (week 0) and post-intervention (week 12)
Symptoms of Fatigue: the Functional Assessment of Chronic Illness Therapy - Fatigue Scale (Yellen et al., 1997)
Délai: Baseline (week 0) and post-intervention (week 12)
Change in self-reported fatigue from baseline to post-intervention.
Baseline (week 0) and post-intervention (week 12)
Affect: Positive and Negative Affect Schedule (Watson et al., 1988)
Délai: Baseline (week 0) and post-intervention (week 12)
Change in self-reported affect from baseline to post-intervention.
Baseline (week 0) and post-intervention (week 12)
Physical Activity Behaviour: Leisure Time Exercise Questionnaire (Godin & Shephard, 1985)
Délai: Baseline (week 0) and post-intervention (week 12)
Change in self-reported physical activity (over the past 7 days) from baseline to post-intervention.
Baseline (week 0) and post-intervention (week 12)
Resting Heart Rate: Heart Rate Monitor (Polar A300)
Délai: Baseline (week 0) and post-intervention (week 12)
Change in resting heart rate from baseline to post-intervention.
Baseline (week 0) and post-intervention (week 12)
Blood Pressure: Blood Pressure Monitor (HealthSmart Digital Blood Pressure Monitor)
Délai: Baseline (week 0) and post-intervention (week 12)
Change in resting blood pressure from baseline to post-intervention.
Baseline (week 0) and post-intervention (week 12)
Body Mass Index: Tanita Scale (TBF-310 GS)
Délai: Baseline (week 0) and post-intervention (week 12)
Change in body mass index from baseline to post-intervention.
Baseline (week 0) and post-intervention (week 12)
Aerobic Capacity: 6-Minute Walk Test (Canadian Society for Exercise Physiology, 2013; Irwin, 2012)
Délai: Baseline (week 0) and post-intervention (week 12)
Change in aerobic capacity (i.e., total distance walked in 6 minutes) from baseline to post-intervention.
Baseline (week 0) and post-intervention (week 12)
Musculoskeletal Strength: Combined Grip Strength Using a Handheld Dynamometer (Canadian Society for Exercise Physiology, 2013, 2013; Irwin, 2012)
Délai: Baseline (week 0) and post-intervention (week 12)
Change in musculoskeletal strength (i.e., force exerted in kilograms on the handheld dynamometer) from baseline to post-intervention.
Baseline (week 0) and post-intervention (week 12)

Collaborateurs et enquêteurs

C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.

Parrainer

University of Ottawa

Les enquêteurs

  • Chercheur principal: Jennifer Brunet, PhD, University of Ottawa

Publications et liens utiles

La personne responsable de la saisie des informations sur l'étude fournit volontairement ces publications. Il peut s'agir de tout ce qui concerne l'étude.

Publications générales

Dates d'enregistrement des études

Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.

Dates principales de l'étude

Début de l'étude (Réel)

1 novembre 2017

Achèvement primaire (Réel)

4 décembre 2019

Achèvement de l'étude (Réel)

4 décembre 2019

Dates d'inscription aux études

Première soumission

7 février 2017

Première soumission répondant aux critères de contrôle qualité

8 février 2017

Première publication (Estimation)

9 février 2017

Mises à jour des dossiers d'étude

Dernière mise à jour publiée (Réel)

10 mars 2020

Dernière mise à jour soumise répondant aux critères de contrôle qualité

6 mars 2020

Dernière vérification

1 mars 2020

Plus d'information

Termes liés à cette étude

Mots clés

Termes MeSH pertinents supplémentaires

Autres numéros d'identification d'étude

  • RectalCaEx-JB-MV-KC

Plan pour les données individuelles des participants (IPD)

Prévoyez-vous de partager les données individuelles des participants (DPI) ?

NON

Informations sur les médicaments et les dispositifs, documents d'étude

Étudie un produit pharmaceutique réglementé par la FDA américaine

Non

Étudie un produit d'appareil réglementé par la FDA américaine

Non

Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .

Essais cliniques sur Cancer rectal

Rechercher des essais similaires

Sponsors et collaborateurs

Les conditions médicales

Interventions en matière de drogue

CROs by country

CROs in Hong Kong

Conditions

Maladies rares

Interventions en matière de drogue

Compléments alimentaires

Commanditaire / collaborateurs

Emplacements

S'abonner