Skip to main content
OpenTrials
Completed

NCT Number: NCT02052050

Core Stability Program 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

Completed

Looking for future studies?

Notify Me

Key information

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Granada. Faculty of Health Sciences

Granada, 18071, Spain

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

Core stability

Other

Primary outcomes

  1. 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

Secondary outcomes

  1. 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)

  2. Body composition:

    Time frame: Baseline- 8 weeks

    It will be obtained with bioelectrical impedance analysis (Inbody 720; Biospace, Seoul, South Korea)

  3. 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.

  4. Static balance

    Time frame: Baseline- 8 weeks

    The Flamingo Test

  5. Flexibility

    Time frame: Baseline- 8 weeks

    The "chair sit and reach test"

  6. Functional capacity

    Time frame: Baseline- 8 weeks

    The 6-min walk test with treadmill (H-P-COSMOS for graphics; Germany)

  7. Fitness perceived

    Time frame: Baseline- 8 weeks

    The International Fitness Scale (IFIS)

  8. Lower back muscle strength

    Time frame: Baseline- 8 weeks

    dynamometer (TKK 5002 Back-A; Takey, Tokyo, Japan)

Other outcomes

  1. Quality of life

    Time frame: Baseline- 8 weeks

  2. Pressure Pain Thresholds

    Time frame: Baseline- 8 weeks

  3. 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.

Sponsors and collaborators

Lead sponsor

Universidad de Granada

Other

Registry information

Official study title

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

Important dates

Study start
2012
Primary completion
2014
Study completion
2015
First posted
Jan 31, 2014
Registry last updated
Jun 3, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.