search
Back to results

Core Stability Program in Colorectal Cancer Survivors

Primary Purpose

Colorectal Cancer

Status
Completed
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
core stability
Sponsored by
Universidad de Granada
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Colorectal Cancer focused on measuring colorectal-neoplasms,deep-muscles of the back,rehabilitation

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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).

Sites / Locations

  • University of Granada. Faculty of Health Sciences

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

core stability

control group

Arm Description

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.

usual care

Outcomes

Primary Outcome Measures

Abdominal isometric endurance
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

Secondary Outcome Measures

Fatigue
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)
Body composition:
It will be obtained with bioelectrical impedance analysis (Inbody 720; Biospace, Seoul, South Korea)
Pain:
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.
Static balance
The Flamingo Test
Flexibility
The "chair sit and reach test"
Functional capacity
The 6-min walk test with treadmill (H-P-COSMOS for graphics; Germany)
Fitness perceived
The International Fitness Scale (IFIS)
Lower back muscle strength
dynamometer (TKK 5002 Back-A; Takey, Tokyo, Japan)

Full Information

First Posted
January 28, 2014
Last Updated
June 1, 2015
Sponsor
Universidad de Granada
search

1. Study Identification

Unique Protocol Identification Number
NCT02052050
Brief Title
Core Stability Program in Colorectal Cancer Survivors
Official Title
Effectiveness of Core Stability Exercises on Abdominal Deep Muscles in Colorectal Cancer Survivors
Study Type
Interventional

2. Study Status

Record Verification Date
January 2014
Overall Recruitment Status
Completed
Study Start Date
September 2012 (undefined)
Primary Completion Date
January 2014 (Actual)
Study Completion Date
April 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Universidad de Granada

4. Oversight

Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Colorectal Cancer
Keywords
colorectal-neoplasms,deep-muscles of the back,rehabilitation

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Non-Randomized
Enrollment
40 (Actual)

8. Arms, Groups, and Interventions

Arm Title
core stability
Arm Type
Experimental
Arm Description
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.
Arm Title
control group
Arm Type
No Intervention
Arm Description
usual care
Intervention Type
Other
Intervention Name(s)
core stability
Primary Outcome Measure Information:
Title
Abdominal isometric endurance
Description
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
Time Frame
Baseline- 8 weeks
Secondary Outcome Measure Information:
Title
Fatigue
Description
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)
Time Frame
Baseline- 8 weeks
Title
Body composition:
Description
It will be obtained with bioelectrical impedance analysis (Inbody 720; Biospace, Seoul, South Korea)
Time Frame
Baseline- 8 weeks
Title
Pain:
Description
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.
Time Frame
Baseline- 8 weeks
Title
Static balance
Description
The Flamingo Test
Time Frame
Baseline- 8 weeks
Title
Flexibility
Description
The "chair sit and reach test"
Time Frame
Baseline- 8 weeks
Title
Functional capacity
Description
The 6-min walk test with treadmill (H-P-COSMOS for graphics; Germany)
Time Frame
Baseline- 8 weeks
Title
Fitness perceived
Description
The International Fitness Scale (IFIS)
Time Frame
Baseline- 8 weeks
Title
Lower back muscle strength
Description
dynamometer (TKK 5002 Back-A; Takey, Tokyo, Japan)
Time Frame
Baseline- 8 weeks
Other Pre-specified Outcome Measures:
Title
Quality of life
Time Frame
Baseline- 8 weeks
Title
Pressure Pain Thresholds
Time Frame
Baseline- 8 weeks
Title
Muscle structure
Description
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.
Time Frame
Baseline- 8 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Irene Cantarero Villanueva, PhD
Organizational Affiliation
Universidad de Granada
Official's Role
Study Chair
Facility Information:
Facility Name
University of Granada. Faculty of Health Sciences
City
Granada
ZIP/Postal Code
18071
Country
Spain

12. IPD Sharing Statement

Citations:
PubMed Identifier
7599766
Citation
Temple PC, Travis B, Sachs L, Strasser S, Choban P, Flancbaum L. Functioning and well-being of patients before and after elective surgical procedures. J Am Coll Surg. 1995 Jul;181(1):17-25.
Results Reference
background
PubMed Identifier
15049716
Citation
Slattery ML. Physical activity and colorectal cancer. Sports Med. 2004;34(4):239-52. doi: 10.2165/00007256-200434040-00004.
Results Reference
background
PubMed Identifier
23017985
Citation
Cantarero-Villanueva I, Fernandez-Lao C, Cuesta-Vargas AI, Del Moral-Avila R, Fernandez-de-Las-Penas C, Arroyo-Morales M. The effectiveness of a deep water aquatic exercise program in cancer-related fatigue in breast cancer survivors: a randomized controlled trial. Arch Phys Med Rehabil. 2013 Feb;94(2):221-30. doi: 10.1016/j.apmr.2012.09.008. Epub 2012 Sep 24.
Results Reference
background
PubMed Identifier
21792370
Citation
Cantarero-Villanueva I, Fernandez-Lao C, Del Moral-Avila R, Fernandez-de-Las-Penas C, Feriche-Fernandez-Castanys MB, Arroyo-Morales M. Effectiveness of core stability exercises and recovery myofascial release massage on fatigue in breast cancer survivors: a randomized controlled clinical trial. Evid Based Complement Alternat Med. 2012;2012:620619. doi: 10.1155/2012/620619. Epub 2011 Jul 17.
Results Reference
background
PubMed Identifier
21705873
Citation
Fernandez-Lao C, Cantarero-Villanueva I, Fernandez-de-Las-Penas C, del Moral-Avila R, Castro-Sanchez AM, Arroyo-Morales M. Effectiveness of a multidimensional physical therapy program on pain, pressure hypersensitivity, and trigger points in breast cancer survivors: a randomized controlled clinical trial. Clin J Pain. 2012 Feb;28(2):113-21. doi: 10.1097/AJP.0b013e318225dc02.
Results Reference
background
PubMed Identifier
27015381
Citation
Cantarero-Villanueva I, Sanchez-Jimenez A, Galiano-Castillo N, Diaz-Rodriguez L, Martin-Martin L, Arroyo-Morales M. Effectiveness of Lumbopelvic Exercise in Colon Cancer Survivors: A Randomized Controlled Clinical Trial. Med Sci Sports Exerc. 2016 Aug;48(8):1438-46. doi: 10.1249/MSS.0000000000000917.
Results Reference
derived
Links:
URL
http://www.cuidateconnosotros.com/
Description
Click here for more information about different studies of this group

Learn more about this trial

Core Stability Program in Colorectal Cancer Survivors

We'll reach out to this number within 24 hrs