NCT02052050

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at below P25 for not_applicable colorectal-cancer

Timeline
Completed

Started Sep 2012

Typical duration for not_applicable colorectal-cancer

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2012

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2014

Completed
27 days until next milestone

First Submitted

Initial submission to the registry

January 28, 2014

Completed
3 days until next milestone

First Posted

Study publicly available on registry

January 31, 2014

Completed
1.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2015

Completed
Last Updated

June 3, 2015

Status Verified

January 1, 2014

Enrollment Period

1.3 years

First QC Date

January 28, 2014

Last Update Submit

June 1, 2015

Conditions

Keywords

colorectal-neoplasms,deep-muscles of the back,rehabilitation

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (8)

  • Fatigue

    Baseline- 8 weeks

  • Body composition:

    Baseline- 8 weeks

  • Pain:

    Baseline- 8 weeks

  • Static balance

    Baseline- 8 weeks

  • Flexibility

    Baseline- 8 weeks

  • +3 more secondary outcomes

Other Outcomes (3)

  • Quality of life

    Baseline- 8 weeks

  • Pressure Pain Thresholds

    Baseline- 8 weeks

  • Muscle structure

    Baseline- 8 weeks

Study Arms (2)

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.

Other: core stability

control group

NO INTERVENTION

usual care

Interventions

core stability

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Granada. Faculty of Health Sciences

Granada, Granada, 18071, Spain

Location

Related Publications (6)

  • 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.

    PMID: 7599766BACKGROUND
  • Slattery ML. Physical activity and colorectal cancer. Sports Med. 2004;34(4):239-52. doi: 10.2165/00007256-200434040-00004.

    PMID: 15049716BACKGROUND
  • 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.

    PMID: 23017985BACKGROUND
  • 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.

    PMID: 21792370BACKGROUND
  • 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.

    PMID: 21705873BACKGROUND
  • 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.

MeSH Terms

Conditions

Colorectal Neoplasms

Interventions

Core Stability

Condition Hierarchy (Ancestors)

Intestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesColonic DiseasesIntestinal DiseasesRectal Diseases

Intervention Hierarchy (Ancestors)

Postural BalanceProprioceptionVestibulocochlear Physiological PhenomenaPhysiological PhenomenaMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological PhenomenaSensationNervous System Physiological Phenomena

Study Officials

  • Irene Cantarero Villanueva, PhD

    Universidad de Granada

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PhD, MD

Study Record Dates

First Submitted

January 28, 2014

First Posted

January 31, 2014

Study Start

September 1, 2012

Primary Completion

January 1, 2014

Study Completion

April 1, 2015

Last Updated

June 3, 2015

Record last verified: 2014-01

Locations