- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02052050
Core Stability Program in Colorectal Cancer Survivors
Effectiveness of Core Stability Exercises on Abdominal Deep Muscles in Colorectal Cancer Survivors
Study Overview
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
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Granada, Spain, 18071
- University of Granada. Faculty of Health Sciences
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
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
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
Sponsor
Investigators
- Study Chair: Irene Cantarero Villanueva, PhD, Universidad de Granada
Publications and helpful links
General Publications
- 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.
- 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.
- Slattery ML. Physical activity and colorectal cancer. Sports Med. 2004;34(4):239-52. doi: 10.2165/00007256-200434040-00004.
- 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.
- 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.
- 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.
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- CEI2013-MP-18
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.
Clinical Trials on Colorectal Cancer
-
University of California, San FranciscoCompletedStage IV Colorectal Cancer AJCC v8 | Stage IVA Colorectal Cancer AJCC v8 | Stage IVB Colorectal Cancer AJCC v8 | Stage IVC Colorectal Cancer AJCC v8 | Stage III Colorectal Cancer AJCC v8 | Stage IIIA Colorectal Cancer AJCC v8 | Stage IIIB Colorectal Cancer AJCC v8 | Stage IIIC Colorectal Cancer AJCC... and other conditionsUnited States
-
Fred Hutchinson Cancer CenterNational Cancer Institute (NCI)TerminatedRectal Cancer | Colon Cancer | Cancer Survivor | Colorectal Adenocarcinoma | Stage III Colorectal Cancer AJCC v8 | Stage IIIA Colorectal Cancer AJCC v8 | Stage IIIB Colorectal Cancer AJCC v8 | Stage IIIC Colorectal Cancer AJCC v8 | Stage I Colorectal Cancer AJCC v8 | Stage II Colorectal Cancer AJCC v8 | Stage... and other conditionsUnited States
-
University of Southern CaliforniaNational Cancer Institute (NCI)TerminatedStage IV Colorectal Cancer AJCC v8 | Stage IVA Colorectal Cancer AJCC v8 | Stage IVB Colorectal Cancer AJCC v8 | Stage IVC Colorectal Cancer AJCC v8 | Stage III Colorectal Cancer AJCC v8 | Stage IIIA Colorectal Cancer AJCC v8 | Stage IIIB Colorectal Cancer AJCC v8 | Stage IIIC Colorectal Cancer AJCC... and other conditionsUnited States
-
M.D. Anderson Cancer CenterNational Cancer Institute (NCI)Active, not recruitingStage IV Colorectal Cancer AJCC v8 | Stage IVA Colorectal Cancer AJCC v8 | Stage IVB Colorectal Cancer AJCC v8 | Stage IVC Colorectal Cancer AJCC v8 | Stage III Colorectal Cancer AJCC v8 | Stage IIIA Colorectal Cancer AJCC v8 | Stage IIIB Colorectal Cancer AJCC v8 | Stage IIIC Colorectal Cancer AJCC... and other conditionsUnited States
-
Wake Forest University Health SciencesNational Cancer Institute (NCI)CompletedCancer Survivor | Stage III Colorectal Cancer AJCC v8 | Stage IIIA Colorectal Cancer AJCC v8 | Stage IIIB Colorectal Cancer AJCC v8 | Stage IIIC Colorectal Cancer AJCC v8 | Stage I Colorectal Cancer AJCC v8 | Stage II Colorectal Cancer AJCC v8 | Stage IIA Colorectal Cancer AJCC v8 | Stage IIB Colorectal... and other conditionsUnited States
-
M.D. Anderson Cancer CenterRecruitingColorectal Adenocarcinoma | Stage IVA Colorectal Cancer AJCC v8 | Stage IVB Colorectal Cancer AJCC v8 | Stage IVC Colorectal Cancer AJCC v8 | Stage III Colorectal Cancer AJCC v8 | Stage IIIA Colorectal Cancer AJCC v8 | Stage IIIB Colorectal Cancer AJCC v8 | Stage IIIC Colorectal Cancer AJCC v8 | Stage... and other conditionsUnited States
-
City of Hope Medical CenterRecruitingColorectal Neoplasms | Colorectal Cancer | Colorectal Adenocarcinoma | Colorectal Cancer Stage II | Colorectal Cancer Stage III | Colorectal Cancer Stage IV | Colorectal Neoplasms Malignant | Colorectal Cancer Stage IUnited States, Japan, Italy, Spain
-
Sidney Kimmel Cancer Center at Thomas Jefferson...United States Department of DefenseActive, not recruitingColorectal Adenoma | Stage III Colorectal Cancer AJCC v8 | Stage IIIA Colorectal Cancer AJCC v8 | Stage IIIB Colorectal Cancer AJCC v8 | Stage IIIC Colorectal Cancer AJCC v8 | Stage 0 Colorectal Cancer AJCC v8 | Stage I Colorectal Cancer AJCC v8 | Stage II Colorectal Cancer AJCC v8 | Stage IIA Colorectal... and other conditionsUnited States
-
University of Roma La SapienzaCompletedColorectal Cancer Stage II | Colorectal Cancer Stage III | Colorectal Cancer Stage IV | Colorectal Cancer Stage 0 | Colorectal Cancer Stage IItaly
-
University of Southern CaliforniaNational Cancer Institute (NCI); AmgenTerminatedStage IV Colorectal Cancer AJCC v7 | Stage IVA Colorectal Cancer AJCC v7 | Stage IVB Colorectal Cancer AJCC v7 | Colorectal Adenocarcinoma | RAS Wild Type | Stage III Colorectal Cancer AJCC v7 | Stage IIIA Colorectal Cancer AJCC v7 | Stage IIIB Colorectal Cancer AJCC v7 | Stage IIIC Colorectal Cancer...United States
Clinical Trials on core stability
-
Riphah International UniversityRecruitingSymphysis Pubis DysfunctionPakistan
-
Kirsehir Ahi Evran UniversitesiRecruiting
-
Riphah International UniversityRecruiting
-
Athanasios EllinoudisCompletedMuscle Atrophy or Weakness | Muscle Contraction | Core StabilityGreece
-
Riphah International UniversityRecruitingSpastic Cerebral PalsyPakistan
-
Cairo UniversityNot yet recruitingPostpartum Sacroiliac Joint Pain
-
Ahi Evran University Education and Research HospitalCompleted
-
University of LahoreCompletedChronic Nonspecific Low Back Pain | Temporomandibular Joint | Core Stability | Jaw MovementsPakistan
-
University School of Physical Education in WroclawCompletedLow Back Pain | Low Back Pain, Mechanical | Low Back Pain, PosturalPoland
-
University GhentCompleted