Strength for Health

Safety and Efficacy of Home-based Resistance Training in Colorectal Cancer Survivors

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.

Study Overview

• Status: Withdrawn
• Conditions: Colon Cancer
• Intervention / Treatment: Behavioral: Exercise; Behavioral: Meditation

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.

• Study Type: Interventional
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Illinois
    • Maywood, Illinois, United States, 60153
      • Loyola University Chicago

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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 Names: 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 Names: A healing meditation for cancer patients CD

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Feasibility of recruitment	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	14 months
Retention feasibility	Retention of at least 80% of randomized patients to the follow-up visit. A drop-out rate of less than 20%	14 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pain	Change in participant reported pain from baseline to 12 weeks	12 weeks
quality of life	Change in Quality of life score as measured by the FACT-C and FACT-F from baseline to 12 weeks	12 weeks
Surgical Complications	Difference in rate of reported surgical complications between arms at 12 weeks	12 weeks
Self-reported Exercise-related Injury	difference in self reported exercise-related injury rate between arms at 12 weeks	12 weeks

Collaborators and Investigators

• Sponsor: Loyola University
• Collaborators: Hygenic Corporation
• Investigators: Principal Investigator: Kathleen Wolin, ScD, Loyola University Chicago

Study record dates

Study Major Dates

• Study Start: June 1, 2013
• Primary Completion (Actual): September 1, 2013
• Study Completion (Actual): September 1, 2013

Study Registration Dates

• First Submitted: June 18, 2013
• First Submitted That Met QC Criteria: June 20, 2013
• First Posted (Estimate): June 21, 2013

Study Record Updates

• Last Update Posted (Estimate): April 15, 2015
• Last Update Submitted That Met QC Criteria: April 14, 2015
• Last Verified: April 1, 2015

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms; Neoplasms by Site; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Intestinal Neoplasms; Colorectal Neoplasms; Colonic Neoplasms
• Other Study ID Numbers: 205243 (Registry Identifier: JAPIC-CTI)