Core Stability Program in Colorectal Cancer Survivors

Colorectal Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02052050
• Other study ID #: CEI2013-MP-18
• Status: Completed
• Phase: N/A
• First received: January 28, 2014
• Last updated: June 1, 2015
• Start date: September 2012
• Est. completion date: April 2015

Study information

• Verified date: January 2014
• Source: Universidad de Granada
• Contact: n/a
• Is FDA regulated: No
• Health authority: Spain: University of Granada
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: April 2015
• Est. primary completion date: January 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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 Design

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Colorectal Cancer
• Colorectal Neoplasms

Intervention

Other:
• core stability

Locations

Country	Name	City	State
Spain	University of Granada. Faculty of Health Sciences	Granada

Sponsors (1)

Lead Sponsor	Collaborator
Universidad de Granada

Country where clinical trial is conducted

Spain, 

References & Publications (5)

Cantarero-Villanueva I, Fernández-Lao C, Cuesta-Vargas AI, Del Moral-Avila R, Fernández-de-Las-Peñas 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. — View Citation

Cantarero-Villanueva I, Fernández-Lao C, Del Moral-Avila R, Fernández-de-Las-Peñas C, Feriche-Fernández-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. — View Citation

Fernández-Lao C, Cantarero-Villanueva I, Fernández-de-Las-Peñas C, del Moral-Ávila R, Castro-Sánchez 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. — View Citation

Slattery ML. Physical activity and colorectal cancer. Sports Med. 2004;34(4):239-52. Review. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Quality of life		Baseline- 8 weeks	No
Other	Pressure Pain Thresholds		Baseline- 8 weeks	No
Other	Muscle structure	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	No
Primary	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	Baseline- 8 weeks	Yes
Secondary	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)	Baseline- 8 weeks	No
Secondary	Body composition:	It will be obtained with bioelectrical impedance analysis (Inbody 720; Biospace, Seoul, South Korea)	Baseline- 8 weeks	No
Secondary	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.	Baseline- 8 weeks	No
Secondary	Static balance	The Flamingo Test	Baseline- 8 weeks	No
Secondary	Flexibility	The "chair sit and reach test"	Baseline- 8 weeks	No
Secondary	Functional capacity	The 6-min walk test with treadmill (H-P-COSMOS for graphics; Germany)	Baseline- 8 weeks	No
Secondary	Fitness perceived	The International Fitness Scale (IFIS)	Baseline- 8 weeks	No
Secondary	Lower back muscle strength	dynamometer (TKK 5002 Back-A; Takey, Tokyo, Japan)	Baseline- 8 weeks	No

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