- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02825810
Cervical Motor Control in Long-term Breast Cancer Survivors
Effectiveness of a Physical Therapy Program for Improving Cervical Motor Control in Long-term Breast Cancer Survivors
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Background: Breast cancer is becoming a common disease; however survival rates have improved throughout the last years. As a result, this also means that breast cancer survivors suffer side effects concerning the disease itself and treatments, as it is the case of certain kinds of pain. It is known that 80% of breast cancer survivors suffer this even 5 years after the completion of treatment and this impairment can be associated with a high tendency towards depression, cardiorespiratory deconditioning and even altered cervical control motor.
Aim: To determine the effectiveness of a physical therapy program based on cervical motor control training in order to improve motor control, mood state and quality of life.
Methods: Fifty-two long-term breast cancer survivors will be allocated to experimental group (n=26) or control group (n=26). The experimental group will receive a nine-week tailored exercise training focused on cervical motor control.
Discussion: There is a lack of knowledge about effective interventions when it comes to deal with altered motor control pattern of cervical area in long-term breast cancer survivors. Therefore, it is necessary to study the impact of this novel approach to improve quality of life in this population.
Study Type
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
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Granada, Spain, 18016
- University of Granada
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- To be over 18 years old
- Have passed a period equal o more 5 years since breast cancer diagnosis
- Have diagnosis of stage I, II or IIIA breast cancer
- Have signed informed consent
- Have medical clearance for participation
- Inability to get level 2 in the craniocervical flexion test
Exclusion Criteria:
- Have diagnosis of arthritis or fibromyalgia
- Have cancer recurrence
- Have been operated through previous surgery of cervical column
- To be taking any treatment for pain or altered motor control during last 12 months
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
No Intervention: Control group
|
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Experimental: Cervical motor control group
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Intervention will consist in a tailored exercise training following a previous published motor control protocol
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Neck Disability Index (NDI)
Time Frame: Participants will be followed over 9 weeks
|
It is self-administered questionnaire to test neck pain interference in daily activities.
It contains 10 items
|
Participants will be followed over 9 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Craniocervical Flexion Test (CCFT)
Time Frame: Participants will be followed over 9 weeks
|
It is used to assess deficit of cervical motor pattern
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Participants will be followed over 9 weeks
|
|
Algometry
Time Frame: Participants will be followed over 9 weeks
|
Pressure pain thresholds (PPTs) will be assessed using an electronic algometer (Somedic AB, Farsta, Sweden)
|
Participants will be followed over 9 weeks
|
|
Visual Analogue Scale (VAS)
Time Frame: Participants will be followed over 9 weeks
|
It is used to assess subjective pain.
It contains scores in the range of 0 to 10 (0 = 'no pain'; 10 = 'worst imaginable pain').
Participants will have to mark the level of pain that they feel in that moment for neck-shoulders areas
|
Participants will be followed over 9 weeks
|
|
Scale for Mood Assessment
Time Frame: Participants will be followed over 9 weeks
|
It is used to assess 4 moods: anxiety, anger-hostility, sadness-depression, and happiness.
It contains 16 items
|
Participants will be followed over 9 weeks
|
|
European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) version 3.0
Time Frame: Participants will be followed over 9 weeks
|
It is used to asses quality of life.
It contains 30 items with both multi-item scales and single-item measures
|
Participants will be followed over 9 weeks
|
|
European Organization for Research and Treatment of Cancer Breast Cancer-Specific Quality of Life Questionnaire (EORTC QLQ-BR23)
Time Frame: Participants will be followed over 9 weeks
|
It is a breast cancer module of EORTC QLQ-C30.
This module contains 23 items assessing disease symptoms, side effects of treatment, body image, sexual functioning, and future perspective
|
Participants will be followed over 9 weeks
|
|
Minnesota Leisure Time Physical Activity Questionnaire (MLTPAQ)
Time Frame: Participants will be followed over 9 weeks
|
It is used to calculate energy expenditure for leisure time physical activity
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Participants will be followed over 9 weeks
|
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International Fitness Scale (IFIS)
Time Frame: Participants will be followed over 9 weeks
|
It is used to assess perceived patients' overall fitness, cardio-respiratory fitness, muscular fitness, speed-agility and flexibility
|
Participants will be followed over 9 weeks
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Irene Cantarero-Villanueva, PhD, Physical Therapy Deparment, Faculty of Health Sciences, University of Granada
Study record dates
Study Major Dates
Study Start
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimated)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- UGR0116
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.
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