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Clinical Trials/NCT02825810
NCT02825810
Withdrawn
Not Applicable

Effectiveness of a Physical Therapy Program for Improving Cervical Motor Control in Long-term Breast Cancer Survivors

Universidad de Granada1 site in 1 countryOctober 1, 2016

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Breast Neoplasms
Sponsor
Universidad de Granada
Locations
1
Primary Endpoint
Neck Disability Index (NDI)
Status
Withdrawn
Last Updated
5 months ago

Overview

Brief Summary

The aim of this study will be to determine the effectiveness of a physical therapy program which is based on cervical motor control exercises in long-term breast cancer survivors in order to improve their motor control and its possible impact on pain, mood state and quality of life.

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.

Registry
clinicaltrials.gov
Start Date
October 1, 2016
End Date
May 1, 2022
Last Updated
5 months ago
Study Type
Interventional
Study Design
Parallel
Sex
Female

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Irene Cantarero Villanueva

PhD

Universidad de Granada

Eligibility Criteria

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

Outcomes

Primary Outcomes

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

Secondary Outcomes

  • Craniocervical Flexion Test (CCFT)(Participants will be followed over 9 weeks)
  • Visual Analogue Scale (VAS)(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(Participants will be followed over 9 weeks)
  • Minnesota Leisure Time Physical Activity Questionnaire (MLTPAQ)(Participants will be followed over 9 weeks)
  • Algometry(Participants will be followed over 9 weeks)
  • Scale for Mood Assessment(Participants will be followed over 9 weeks)
  • International Fitness Scale (IFIS)(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)(Participants will be followed over 9 weeks)

Study Sites (1)

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