Colorectal CancerNCT02052050
Core Stability Program in Colorectal Cancer Survivors
A study testing core stability in people with Colorectal Cancer, run by Universidad de Granada at 1 site in Spain.
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 Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Colorectal Cancer
- What is being tested?
- core stability
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteSpain
- Study dates
- Sep 2012to Apr 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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).
Trial locations and contacts
1 site in 1 country.
Spain1 site
University of Granada. Faculty of Health Sciences
Granada, Granada, 18071
About this study
Official title: 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
Read the 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.
- Conditions
- Colorectal Cancer
- Being tested
- core stability
- Keywords
- colorectal-neoplasms,deep-muscles of the back,rehabilitation
- Medical subject headings
- Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
core stabilityOther
| Study group | Role | What they receive |
|---|---|---|
| core stability | Experimental | 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. Receives: Other: core stability |
| control group | No intervention | usual care |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Baseline- 8 weeks
Secondary outcomes (8)
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)
Measured: Baseline- 8 weeks
Body composition:
It will be obtained with bioelectrical impedance analysis (Inbody 720; Biospace, Seoul, South Korea)
Measured: Baseline- 8 weeks
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.
Measured: Baseline- 8 weeks
Static balance
The Flamingo Test
Measured: Baseline- 8 weeks
Flexibility
The "chair sit and reach test"
Measured: Baseline- 8 weeks
Functional capacity
The 6-min walk test with treadmill (H-P-COSMOS for graphics; Germany)
Measured: Baseline- 8 weeks
Fitness perceived
The International Fitness Scale (IFIS)
Measured: Baseline- 8 weeks
Lower back muscle strength
dynamometer (TKK 5002 Back-A; Takey, Tokyo, Japan)
Measured: Baseline- 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jan 2014 (estimated)
- Study startSep 2012
- Primary completionJan 2014
- Study completionApr 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Colorectal CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidad de Granada
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Manuel Arroyo Morales, Universidad de Granada
- Investigators
- Irene Cantarero Villanueva, PhD, Study chair, Universidad de Granada
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02052050
- Sponsor's protocol ID
- CEI2013-MP-18
- Status last verified
- Jan 2014
- First submitted
- 28 Jan 2014
- Last updated
- 3 Jun 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 7599766Slattery ML. Physical activity and colorectal cancer. Sports Med. 2004;34(4):239-52. doi: 10.2165/00007256-200434040-00004.
PubMed 15049716Cantarero-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.
PubMed 23017985Cantarero-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.
PubMed 21792370Fernandez-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.
PubMed 21705873Cantarero-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.
PubMed 27015381
Study at a glance
From the registry record, last updated by the sponsor on 3 Jun 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Core Stability Exercises on Abdominal Deep Muscles in Colorectal Cancer Survivors
- ClinicalTrials.gov ID
- NCT02052050
- Acronym / sponsor ID
- CEI2013-MP-18
- Conditions
- Colorectal Cancer
- Keywords
- colorectal-neoplasms,deep-muscles of the back,rehabilitation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Universidad de GranadaUniversity, hospital or other
- Study start
- Sep 2012
- Primary completion
- Jan 2014 (actual)
- Study completion
- Apr 2015 (actual)
- First posted
- 31 Jan 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| core stability | Experimental | Other: core stabilityStabilized 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. |
| control group | No intervention | –usual care |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (1 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| core stability | Other | core stability |
Primary outcome
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
8 secondary outcomes
Fatigue
Time frame: Baseline- 8 weeks
Body composition:
Time frame: Baseline- 8 weeks
Pain:
Time frame: Baseline- 8 weeks
Static balance
Time frame: Baseline- 8 weeks
Flexibility
Time frame: Baseline- 8 weeks
Functional capacity
Time frame: Baseline- 8 weeks
Fitness perceived
Time frame: Baseline- 8 weeks
Lower back muscle strength
Time frame: Baseline- 8 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jun 2015.
- Background: PubMed 7599766Temple 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.
- Background: PubMed 15049716Slattery ML. Physical activity and colorectal cancer. Sports Med. 2004;34(4):239-52. doi: 10.2165/00007256-200434040-00004.
- Background: PubMed 23017985Cantarero-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.
- Background: PubMed 21792370Cantarero-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.
- Background: PubMed 21705873Fernandez-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.
- Derived from this study: PubMed 27015381Cantarero-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.
- Click here for more information about different studies of this groupLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Irene Cantarero Villanueva, PhD study chair
Universidad de Granada
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing core stability in people with Colorectal Cancer, run by Universidad de Granada at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Jun 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Abdominal isometric endurance (time frame: Baseline- 8 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02052050, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Jun 2015.