Strength for Health

NCT01882972 | Withdrawn

• 1 other identifier: 205243
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Colon Cancer

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (4)

• Pain

  12 weeks

• quality of life

  12 weeks

• Surgical Complications

  12 weeks

• Self-reported Exercise-related Injury

  12 weeks

Study Arms (2)

Exercise

EXPERIMENTAL

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

control

PLACEBO COMPARATOR

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

Interventions

Exercise BEHAVIORAL

Also known as: Home-based exercise using Therabands

Exercise

Meditation BEHAVIORAL

Also known as: A healing meditation for cancer patients CD

control

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Loyola University: lead
• Hygenic Corporation: collaborator

Study Sites (1)

Loyola University Chicago

Maywood, Illinois, 60153, United States

Location

MeSH Terms

Conditions

Colonic Neoplasms

Interventions

Exercise; Meditation

Condition Hierarchy (Ancestors)

Colorectal Neoplasms; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena; Mind-Body Therapies; Complementary Therapies; Therapeutics; Spiritual Therapies; Relaxation Therapy; Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities

Study Officials

• Kathleen Wolin, ScD

  Loyola University Chicago

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: June 18, 2013
• First Posted: June 21, 2013
• Study Start: June 1, 2013
• Primary Completion: September 1, 2013
• Study Completion: September 1, 2013
• Last Updated: April 15, 2015

Record last verified: 2015-04

Locations

US (1)