Strength for Health

This study is currently recruiting participants.
Verified June 2013 by Loyola University
Sponsor:
Collaborator:
Hygenic Corporation
Information provided by (Responsible Party):
Kate Wolin, Loyola University Chicago
ClinicalTrials.gov Identifier:
NCT01882972
First received: June 18, 2013
Last updated: June 20, 2013
Last verified: June 2013
  Purpose

Despite a robust literature on the benefits of exercise for cancer survivors, most of the research to date falls in two primary areas - aerobic exercise and breast cancer survivors. The focus on aerobic training alone is a concern as resistance training is critical for building the muscle mass necessary to maintain physical function. However, concerns have been raised about the potential for higher than tolerated adverse event rates during resistance training, particularly that which is unsupervised, despite a history of safe use of resistance training in other chronically diseased patient populations. The aim of this pilot study is to demonstrate the feasibility, safety and quality of life benefit of a home-based resistance-training program among colorectal cancer survivors. The investigators will recruit n=30 men and women with stage I-III colon cancer. Participants will be randomized to a home-based exercise intervention that combines aerobic and resistance exercise. Control arm participants will receive a home-based meditation program.


Condition Intervention
Colon Cancer
Behavioral: Exercise
Behavioral: Meditation

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Supportive Care
Official Title: Safety and Efficacy of Home-based Resistance Training in Colorectal Cancer Survivors

Resource links provided by NLM:


Further study details as provided by Loyola University:

Primary Outcome Measures:
  • Feasibility of recruitment [ Time Frame: 14 months ] [ Designated as safety issue: No ]
    Ability to meet the recruitment goal of 30 subjects in a 14 month period, reflecting a participation rate of at least 20% among approached and eligible patients

  • Retention feasibility [ Time Frame: 14 months ] [ Designated as safety issue: No ]
    Retention of at least 80% of randomized patients to the follow-up visit. A drop-out rate of less than 20%


Secondary Outcome Measures:
  • Pain [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ]
    Change in participant reported pain from baseline to 12 weeks

  • quality of life [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
    Change in Quality of life score as measured by the FACT-C and FACT-F from baseline to 12 weeks

  • Surgical Complications [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ]
    Difference in rate of reported surgical complications between arms at 12 weeks

  • Self-reported Exercise-related Injury [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ]
    difference in self reported exercise-related injury rate between arms at 12 weeks


Estimated Enrollment: 30
Study Start Date: June 2013
Estimated Primary Completion Date: June 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Exercise
Exercise 12 week home-based resistance exercise training intervention. Participants will be coached to engage in resistance training 3 days per week and aerobic exercise for 30 minutes at least 5 days per week for 12 weeks.
Behavioral: Exercise
Other Name: Home-based exercise using Therabands
Placebo Comparator: control
Participants in the attention control arm will not be asked to cease activity they already participate in but will be instructed not to begin a new exercise program for 12 weeks. Participants will receive a meditation CD to use daily to account for the time intervention arm participants are engaged in exercise.
Behavioral: Meditation
Other Name: A healing meditation for cancer patients CD

Detailed Description:

The investigators will recruit n=30 patients with stage I-III colorectal cancer and randomize them to a 12-week resistance training intervention with Theraband and existing evidence- based materials or attention control using a meditation intervention. Using an electronic survey tool, patients will complete a baseline questionnaire on key outcomes (quality of life, fatigue, side effects) and potential confounders and will consent to a medical record review. These will also be assessed via at 4 weeks post randomization and 12 weeks post randomization. Participants in the intervention group will receive one-time in person instruction in the exercises derived from the existing evidence base of home-based resistance training programs for older adults and cancer survivors. They will be sent home with a book demonstrating the exercises, a log and a set of appropriate resistance bands. Weekly follow-up calls will occur for the duration of the intervention and updates on the call results will be provided to the colon cancer clinic nurse so that care is integrated. Participants in the attention control group will be mailed a meditation CD. Follow-up in the control group will parallel that of the intervention group, with weekly calls.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • stage I-III colorectal cancer
  • completed surgical treatment
  • at least 12 weeks post-surgery.
  • at least 4 weeks post adjuvant therapy.
  • age 18 and older.

Exclusion Criteria:

  • patients who had surgery more than 24 months ago.
  • patients with related pre-existing conditions (i.e., Crohn's disease, ulcerative colitis, familial polyposis syndromes).
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01882972

Contacts
Contact: Kate Wolin, ScD 7083279088 kwolin@luc.edu

Locations
United States, Illinois
Loyola University Chicago Recruiting
Maywood, Illinois, United States, 60153
Contact: Elaine Fluder, MSN    708-216-6198    efluder@lumc.edu   
Principal Investigator: Kate Wolin, Scd         
Sub-Investigator: Joshua Eberhardt, MD         
Sponsors and Collaborators
Loyola University
Hygenic Corporation
Investigators
Principal Investigator: Kathleen Wolin, ScD Loyola University Chicago
  More Information

No publications provided

Responsible Party: Kate Wolin, Associate Professor, Loyola University Chicago
ClinicalTrials.gov Identifier: NCT01882972     History of Changes
Other Study ID Numbers: 205243
Study First Received: June 18, 2013
Last Updated: June 20, 2013
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Colonic Neoplasms
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases

ClinicalTrials.gov processed this record on April 22, 2014