Clinical trial NCT01882972: Strength for Health
Official title: Safety and Efficacy of Home-based Resistance Training in Colorectal Cancer Survivors
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Colon Cancer
Lead sponsor: Loyola University
Sponsor class: OTHER
Collaborators: name: Hygenic Corporation
First posted: 2013-06-21
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

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).

Primary outcomes:
measure: Feasibility of recruitment
timeFrame: 14 months
measure: Retention feasibility
timeFrame: 14 months
Secondary outcomes:
measure: Pain
timeFrame: 12 weeks
measure: quality of life
timeFrame: 12 weeks
measure: Surgical Complications
timeFrame: 12 weeks
measure: Self-reported Exercise-related Injury
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Maywood
country: United States
facility: Loyola University Chicago
state: Illinois
Study officials:
affiliation: Loyola University Chicago
name: Kathleen Wolin, ScD
role: PRINCIPAL_INVESTIGATOR
References: