Core Stability Program in Colorectal Cancer Survivors

June 1, 2015 updated by: Manuel Arroyo Morales, Universidad de Granada

Effectiveness of Core Stability Exercises on Abdominal Deep Muscles in Colorectal Cancer Survivors

The purpose of this study is to determine the effects of physical training program to improve deep stabilizer muscle in colorectal cancer survivors

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Background: Colorectal cancer is the third most common cancer when considering both genders. Musculoskeletal alterations have been described related to techniques used during surgery, that it produces an inhibition of deep abdominal muscles. These muscles are in charge of lumbopelvic stabilization muscle linked to reduced ability to maintain independence in daily activity life that could have affected their quality of life

Objective: The aim objective will be evaluated short and long-term effects of physical activity program for muscle stabilization.

Methods: 20 colorectal cancer survivors will be recruited from the Department of Oncology of Clínico San Cecilio Hospital. Patients will be randomized in physical activity program group and usual care group. Physical activity groups will receive an eight week program form improve the muscle stabilization.

Discussion: Researchers attempts to increase the fitness level and reduce musculoskeletal disorders in colorectal cancer survivors through a physical activity interventions focusing in muscle stabilization.

Study Type

Interventional

Enrollment (Actual)

40

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Granada, Spain, 18071
        • University of Granada. Faculty of Health Sciences

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Patients under partial colorectal resection to treat colon cancer
  • Diagnosis of I, II or IIIa stage of colorectal cancer
  • Completion of adjuvant therapy (except for hormone therapy)
  • Medical clearance of participation

Exclusion Criteria:

Participants will be excluded if they presents with cancer recurrence or if they will have undergone previous abdominal surgeries or will be diagnosed with concomitant conditions, such as previous lower-back pain or musculoskeletal conditions (e.g., osteoarthritis, fibromyalgia or chronic fatigue syndrome).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: control group
usual care
Experimental: core stability
Stabilized muscle program will consist of two months of individual physical training that it will be conducted 3 times/week for 90 min each. A correct progression to improve stabilization of deep abdominal muscles will be made.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Abdominal isometric endurance
Time Frame: Baseline- 8 weeks
Isometric endurance of trunk flexors will be used to determine endurance strength of abdominal muscles. Patients will be laid supine, maintaining hips and knees bent at 90 degrees, feet flat approximately 30 inches from the buttocks and arms extended with hands on knees without actually touching. Patients will be instructed to separate the trunk from the stretcher to the inferior angle of the scapula and maintain this position as long as possible. Time (in seconds) will be measured until a maximum of 90 seconds
Baseline- 8 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Fatigue
Time Frame: Baseline- 8 weeks
The Piper Fatigue Scale will be used for it measure. It scale includes 22 items and four dimensions (behavioural/severity, affective meaning, sensory and cognitive mood)
Baseline- 8 weeks
Body composition:
Time Frame: Baseline- 8 weeks
It will be obtained with bioelectrical impedance analysis (Inbody 720; Biospace, Seoul, South Korea)
Baseline- 8 weeks
Pain:
Time Frame: Baseline- 8 weeks
The participants will be completed a visual analogue scale to assess the presence of lower-back and/or abdominal pain. The Brief Pain Inventory (BPI) will be used to assess the interference and the experience of pain.
Baseline- 8 weeks
Static balance
Time Frame: Baseline- 8 weeks
The Flamingo Test
Baseline- 8 weeks
Flexibility
Time Frame: Baseline- 8 weeks
The "chair sit and reach test"
Baseline- 8 weeks
Functional capacity
Time Frame: Baseline- 8 weeks
The 6-min walk test with treadmill (H-P-COSMOS for graphics; Germany)
Baseline- 8 weeks
Fitness perceived
Time Frame: Baseline- 8 weeks
The International Fitness Scale (IFIS)
Baseline- 8 weeks
Lower back muscle strength
Time Frame: Baseline- 8 weeks
dynamometer (TKK 5002 Back-A; Takey, Tokyo, Japan)
Baseline- 8 weeks

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Quality of life
Time Frame: Baseline- 8 weeks
Baseline- 8 weeks
Pressure Pain Thresholds
Time Frame: Baseline- 8 weeks
Baseline- 8 weeks
Muscle structure
Time Frame: Baseline- 8 weeks
An ultrasound device (MyLab™ 25, Esaote Medical Systems, Genova, Italy) and a 12 MHz linear probe will be used in this study. The depth of internal and external oblique and transversus abdominis, and depth and width of lumbar multifidus will be captured when the patient will be relaxed at the end of the expiration movement.
Baseline- 8 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Study Chair: Irene Cantarero Villanueva, PhD, Universidad de Granada

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2012

Primary Completion (Actual)

January 1, 2014

Study Completion (Actual)

April 1, 2015

Study Registration Dates

First Submitted

January 28, 2014

First Submitted That Met QC Criteria

January 30, 2014

First Posted (Estimate)

January 31, 2014

Study Record Updates

Last Update Posted (Estimate)

June 3, 2015

Last Update Submitted That Met QC Criteria

June 1, 2015

Last Verified

January 1, 2014

More Information

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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