Questa pagina è stata tradotta automaticamente e l'accuratezza della traduzione non è garantita. Si prega di fare riferimento al Versione inglese per un testo di partenza.

Exercise for Adults Diagnosed With Rectal Cancer

6 marzo 2020 aggiornato da: 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.

Panoramica dello studio

Stato

Ritirato

Condizioni

Intervento / Trattamento

Tipo di studio

Interventistico

Fase

  • Non applicabile

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Luoghi di studio

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

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

Da 18 anni a 85 anni (Adulto, Adulto più anziano)

Accetta volontari sani

No

Sessi ammissibili allo studio

Tutto

Descrizione

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.

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Terapia di supporto
  • Assegnazione: N / A
  • Modello interventistico: Assegnazione di gruppo singolo
  • Mascheramento: Nessuno (etichetta aperta)

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Sperimentale: Exercise
Participants will be asked to complete a 12-week exercise intervention and all study assessments.
Comportamentale: 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.

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Recruitment Rates
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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

Altre misure di risultato

Misura del risultato
Misura Descrizione
Lasso di tempo
Socio-Demographic and Medical Information Questionnaire
Lasso di tempo: 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)
Lasso di tempo: 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)
Lasso di tempo: 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)
Lasso di tempo: 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)
Lasso di tempo: 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)
Lasso di tempo: 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)
Lasso di tempo: 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)
Lasso di tempo: 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)
Lasso di tempo: 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)
Lasso di tempo: 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)
Lasso di tempo: 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)

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

University of Ottawa

Investigatori

  • Investigatore principale: Jennifer Brunet, PhD, University of Ottawa

Pubblicazioni e link utili

La persona responsabile dell'inserimento delle informazioni sullo studio fornisce volontariamente queste pubblicazioni. Questi possono riguardare qualsiasi cosa relativa allo studio.

Pubblicazioni generali

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Effettivo)

1 novembre 2017

Completamento primario (Effettivo)

4 dicembre 2019

Completamento dello studio (Effettivo)

4 dicembre 2019

Date di iscrizione allo studio

Primo inviato

7 febbraio 2017

Primo inviato che soddisfa i criteri di controllo qualità

8 febbraio 2017

Primo Inserito (Stima)

9 febbraio 2017

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

10 marzo 2020

Ultimo aggiornamento inviato che soddisfa i criteri QC

6 marzo 2020

Ultimo verificato

1 marzo 2020

Maggiori informazioni

Termini relativi a questo studio

Parole chiave

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

  • RectalCaEx-JB-MV-KC

Piano per i dati dei singoli partecipanti (IPD)

Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?

NO

Informazioni su farmaci e dispositivi, documenti di studio

Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti

No

Studia un dispositivo regolamentato dalla FDA degli Stati Uniti

No

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

Prove cliniche su Cancro rettale

Cerca prove simili

Sponsor e collaboratori

Condizioni mediche

Interventi farmacologici

CROs by country

CROs in Congo

Condizioni

Malattie rare

Interventi farmacologici

Supplementi dietetici

Sponsor / Collaboratori

Sedi

3
Sottoscrivi