Strength for Health

NCT ID: NCT01882972

Last Updated: 2015-04-15

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: NA
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-06-30
• Study Completion Date: 2013-09-30

Brief Summary

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.

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.

Conditions

Colon Cancer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: SINGLE

Study Groups

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.

Group Type: EXPERIMENTAL

Exercise

Intervention Type: BEHAVIORAL

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.

Group Type: PLACEBO_COMPARATOR

Meditation

Intervention Type: BEHAVIORAL

Interventions

Exercise

Intervention Type: BEHAVIORAL

Meditation

Intervention Type: BEHAVIORAL

Other Intervention Names

Home-based exercise using Therabands; A healing meditation for cancer patients CD

Eligibility 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).

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Hygenic Corporation

UNKNOWN

Sponsor Role: collaborator

Loyola University

OTHER

Sponsor Role: lead

Responsible Party

Kate Wolin

Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Kathleen Wolin, ScD

Role: PRINCIPAL_INVESTIGATOR

Loyola University Chicago

Locations

Loyola University Chicago

Maywood, Illinois, United States

Countries

United States

Other Identifiers

205243

Identifier Type: -

Identifier Source: org_study_id