search
Back to results

Effect Of Exercises On Kinesiophobia, And Other Symptoms Related to Osteoporosis

Primary Purpose

Osteoporosis

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Exercise
Sponsored by
Eastern Mediterranean University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Osteoporosis focused on measuring Osteoporosis, Clinic Pilates Exercise, Kinesiophobia, Pain

Eligibility Criteria

50 Years - 75 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

  • Woman diagnosed with osteoporosis between the ages 50-75 within the last year

Exclusion Criteria

  • History of fractures
  • Joint replacements or fixation of the joints at the lower extremities or the spine
  • Any neurological or muscle diseases
  • Inability to continuously attend the exercise program
  • Any secondary diseases resulting in decreased mobility or functional status
  • Visual, hearing or mental problems that could prevent communication

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    No Intervention

    Arm Label

    Exercise Group,

    Control Group

    Arm Description

    Clinical Pilates exercise were given for 6 weeks, 3 days in a week

    Nothing given to control group, told to continue their normal life for 6 weeks.

    Outcomes

    Primary Outcome Measures

    Change in the level of fear and avoidance associated with movement assessed using the Tampa Kinesiophobia Scale at 6 weeks
    40 osteoporosis patients filled Tampa Kinesiophobia Scale at the beginning and at the end of 6 weeks in order to measure the level of fear and avoidance associated with movement. If an individual receives a high score, according to the scale, this result indicates a high level of kinesiophobia . It has not a specific unit. There is not an adverse events in this test.

    Secondary Outcome Measures

    Change in the level of pain intensity in the morning assessed using Visual Analogue Scale (VAS) at 6 weeks.
    VAS is an horizontal line, 100 mm in length, anchored by word descriptors at each end. The patient marks on the line the point that they feel represents their perception of their current pain intensity. The VAS score is determined by measuring in millimetres from the left hand end of the line to the point that the patient marks and recorded in centiemeters (cm).
    Change in the level of pain intensity during activity assessed using Visual Analogue Scale (VAS) at 6 weeks.
    VAS is an horizontal line, 100 mm in length, anchored by word descriptors at each end. The patient marks on the line the point that they feel represents their perception of their current pain intensity. The VAS score is determined by measuring in millimetres from the left hand end of the line to the point that the patient marks and recorded in centiemeters (cm).
    Change in the level of pain intensity at rest assessed using Visual Analogue Scale (VAS) at 6 weeks.
    VAS is an horizontal line, 100 mm in length, anchored by word descriptors at each end. The patient marks on the line the point that they feel represents their perception of their current pain intensity. The VAS score is determined by measuring in millimetres from the left hand end of the line to the point that the patient marks and recorded in centiemeters (cm).
    Change in the level of experienced pain assessed with using Short Form - McGill Pain Questionnaire (SF-McGill)
    Short Form - McGill Pain Questionnaire (SF-McGill) provides a multidimensional evaluation of the experienced pain. Patients' pain descriptions (SF-McGill S), experienced pain level during study (Sf-McGill VAS) and total pain intensity measured via a 6-point Likert- Type Scale (SF-McGill L) was recorded.
    Change in the level of influence of patients' general pain intensity on their daily life activities and functionality assessed using Pain Disability Index (PDI).
    Pain Disability Index (PDI) (score out of 70) is a questionnaire filled by the patients.
    Change in the level of influence of patients' low back pain intensity on their daily life activities and functionality assessed using Oswestry Low Back Pain Disability Scale (ODI)
    Oswestry Low Back Pain Disability Scale (ODI)(score out of 70) is a questionnaire filled by the patients .
    Change in the level of functional balance assessed using Berg Balance Test (BBT).
    Berg Balance Test (BBT)(score out of 56) evaluates postural control mechanism and dynamic and static balance while doing functional activities in adult population. This test was assessed by the physiotherapist.
    Change in the level of functional balance assessed using The Timed Up and Go Test (TUG).
    The Timed Up and Go Test (TUG) assesses the functional balance and mobility of subjects. Patients stands up upon therapist's command walks 3 meters, turns around, walks back to the chair and sits down. The performance is repeated by the patience 3 times and the shortest performance time is recorded in seconds (sec).
    Change in the level of lower extremity proximal muscle's strength and endurance assessed using Chair Sit and Stand Test (CSST) at 6 weeks.
    In Chair Sit and Stand Test (CSST), number of sitting-standing repetitions in 30 sec. was recorded by the physiotherapist.
    Change in the level of functional flexibility of lower extremity assessed using Chair Sit and Stand Test (CSST) at 6 weeks.
    assesses the functional flexibility of the lower extremity in adult (23). Participant sits on the edge of a chair. One foot must remain flat on the floor. The other leg is extended forward with the knee straight, heel on the floor, and ankle bent at 90°. Patients place one hand on top of the other with tips of the middle fingers even. Patients keep the knee straight, and hold the reach for 2 seconds. If the fingertips touch the toes then the score is zero (0). If they do not touch, measure the distance between the fingers and the toes (a negative score/-), if they overlap, measure by how much (a positive score/+) and recorded in cm.
    Change in the level of functional flexibility of upper extremity assessed using Back Scratch Test (BST) at 6 weeks.
    Back Scratch Test (BST)(cm) evaluates the functional flexibility of the patient's upper extremity. Patients are asked to rotate their shoulder externally with palms facing their back. Their hand fingers extend while trying to reach the lowest point, the other arm internally rotates while trying to reach the highest point. Patients are asked their fingertips to be closer to each other. If finger tips do not touch each other, the distance between them is recorded in cm assumed as a negative score, if the fingertips touch each other, then the score is assumed as zero. If they overlap, it is recorded in cm taking as positive score. Three repetitions are performed consecutively and the best score was recorded.
    Change in the level of quality of life assessed using Quality of Life Questionnaire of the European Foundation for Osteoporosis (QUALEFFO-41) at 6 weeks
    A. Quality of Life Questionnaire of the European Foundation for Osteoporosis (QUALEFFO-41) examine the five dimensions of health such as pain, physical functioning, social activities, general health assessment and mental function of patients with osteoporosis. Quality of Life Questionnaire of the European Foundation for Osteoporosis (QUALEFFO-41) was filled by the patients and score was calculated as percentage (%).
    Change in the level of anxiety and depression assessed using Hospital Anxiety And Depression Scale (HADS) at 6 weeks
    This scale was filled by the patients. It has no special units. The elevation of the total score indicates the increased anxiety and depression levels (score out of 42).
    Change in the level of chronic functional impairment assessed using Health Assessment Questionnaire (HAQ) at 6 weeks
    Health Assessment Questionnaire (HAQ) (score out of 24) is commonly used for evaluating the patients' chronic functional impairment caused by rheumatic diseases. This questionnaire was filled by the patients and it has no special units.
    Change in the level of life satisfaction assessed using Satisfaction with Life Scale (SLS) at 6 weeks
    This scale (score out of 35) was filled by the patients. It has no special units.

    Full Information

    First Posted
    March 3, 2016
    Last Updated
    March 23, 2016
    Sponsor
    Eastern Mediterranean University
    search

    1. Study Identification

    Unique Protocol Identification Number
    NCT02716844
    Brief Title
    Effect Of Exercises On Kinesiophobia, And Other Symptoms Related to Osteoporosis
    Official Title
    The Effect Of The Clinical Pilates Exercises On Kinesiophobia, And Other Symptoms Related to Osteoporosis
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    March 2016
    Overall Recruitment Status
    Completed
    Study Start Date
    January 2015 (undefined)
    Primary Completion Date
    March 2016 (Actual)
    Study Completion Date
    March 2016 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Eastern Mediterranean University

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    Aim: Investigating the effects of Clinical Pilates Exercise on kinesiophobia, pain, functional status and quality of life of the patients diagnosed with osteoporosis. Method: 47 patients were assessed and randomly divided into 2 groups. Exercise group patients joined exercise program regularly that was held 3 times a week, 1 hour a day, during 6 weeks with physiotherapist. Control group patients continued their normal daily lives without any exercise. After 7 patients quit the study for various reasons, 40 women with primary osteoporosis (control group n=20, exercise group n= 20), completed the study and were assessed at the beginning and at the end of 6 weeks. As assesment' measurements Tampa Kinesiophobia Scale (TKS), Visual Analog Scale (VAS), Short Form McGill (SF-McGill), Pain Disability Index (PDI), Oswestry Disability Index (ODI), Berg Balance Test (BBT), Timed Up- Go Test (TUG), Chair Sit-Stand Test (CSST), Chair Sit and Reach Test (CSRT), Back Scratch Test (BST), Quality of life Questionnaire European Foundation for Osteoporosis (QUALEFFO-41), Hospital Anxiety and Depression Scale (HADS), Satisfaction with Life Scale (SLS) and Health Assesment Questionnaire (HAQ) were performed.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Osteoporosis
    Keywords
    Osteoporosis, Clinic Pilates Exercise, Kinesiophobia, Pain

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    Outcomes Assessor
    Allocation
    Randomized
    Enrollment
    47 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Exercise Group,
    Arm Type
    Experimental
    Arm Description
    Clinical Pilates exercise were given for 6 weeks, 3 days in a week
    Arm Title
    Control Group
    Arm Type
    No Intervention
    Arm Description
    Nothing given to control group, told to continue their normal life for 6 weeks.
    Intervention Type
    Other
    Intervention Name(s)
    Exercise
    Intervention Description
    Clinical Pilates exercise were given for 6 weeks, 3 days in a week
    Primary Outcome Measure Information:
    Title
    Change in the level of fear and avoidance associated with movement assessed using the Tampa Kinesiophobia Scale at 6 weeks
    Description
    40 osteoporosis patients filled Tampa Kinesiophobia Scale at the beginning and at the end of 6 weeks in order to measure the level of fear and avoidance associated with movement. If an individual receives a high score, according to the scale, this result indicates a high level of kinesiophobia . It has not a specific unit. There is not an adverse events in this test.
    Time Frame
    At the beginning and at the end of 6 weeks
    Secondary Outcome Measure Information:
    Title
    Change in the level of pain intensity in the morning assessed using Visual Analogue Scale (VAS) at 6 weeks.
    Description
    VAS is an horizontal line, 100 mm in length, anchored by word descriptors at each end. The patient marks on the line the point that they feel represents their perception of their current pain intensity. The VAS score is determined by measuring in millimetres from the left hand end of the line to the point that the patient marks and recorded in centiemeters (cm).
    Time Frame
    At the beginning and at the end of 6 weeks
    Title
    Change in the level of pain intensity during activity assessed using Visual Analogue Scale (VAS) at 6 weeks.
    Description
    VAS is an horizontal line, 100 mm in length, anchored by word descriptors at each end. The patient marks on the line the point that they feel represents their perception of their current pain intensity. The VAS score is determined by measuring in millimetres from the left hand end of the line to the point that the patient marks and recorded in centiemeters (cm).
    Time Frame
    At the beginning and at the end of 6 weeks
    Title
    Change in the level of pain intensity at rest assessed using Visual Analogue Scale (VAS) at 6 weeks.
    Description
    VAS is an horizontal line, 100 mm in length, anchored by word descriptors at each end. The patient marks on the line the point that they feel represents their perception of their current pain intensity. The VAS score is determined by measuring in millimetres from the left hand end of the line to the point that the patient marks and recorded in centiemeters (cm).
    Time Frame
    At the beginning and at the end of 6 weeks
    Title
    Change in the level of experienced pain assessed with using Short Form - McGill Pain Questionnaire (SF-McGill)
    Description
    Short Form - McGill Pain Questionnaire (SF-McGill) provides a multidimensional evaluation of the experienced pain. Patients' pain descriptions (SF-McGill S), experienced pain level during study (Sf-McGill VAS) and total pain intensity measured via a 6-point Likert- Type Scale (SF-McGill L) was recorded.
    Time Frame
    At the beginning and at the end of 6 weeks
    Title
    Change in the level of influence of patients' general pain intensity on their daily life activities and functionality assessed using Pain Disability Index (PDI).
    Description
    Pain Disability Index (PDI) (score out of 70) is a questionnaire filled by the patients.
    Time Frame
    At the beginning and at the end of 6 weeks
    Title
    Change in the level of influence of patients' low back pain intensity on their daily life activities and functionality assessed using Oswestry Low Back Pain Disability Scale (ODI)
    Description
    Oswestry Low Back Pain Disability Scale (ODI)(score out of 70) is a questionnaire filled by the patients .
    Time Frame
    At the beginning and at the end of 6 weeks
    Title
    Change in the level of functional balance assessed using Berg Balance Test (BBT).
    Description
    Berg Balance Test (BBT)(score out of 56) evaluates postural control mechanism and dynamic and static balance while doing functional activities in adult population. This test was assessed by the physiotherapist.
    Time Frame
    At the beginning and at the end of 6 weeks
    Title
    Change in the level of functional balance assessed using The Timed Up and Go Test (TUG).
    Description
    The Timed Up and Go Test (TUG) assesses the functional balance and mobility of subjects. Patients stands up upon therapist's command walks 3 meters, turns around, walks back to the chair and sits down. The performance is repeated by the patience 3 times and the shortest performance time is recorded in seconds (sec).
    Time Frame
    At the beginning and at the end of 6 weeks
    Title
    Change in the level of lower extremity proximal muscle's strength and endurance assessed using Chair Sit and Stand Test (CSST) at 6 weeks.
    Description
    In Chair Sit and Stand Test (CSST), number of sitting-standing repetitions in 30 sec. was recorded by the physiotherapist.
    Time Frame
    At the beginning and at the end of 6 weeks
    Title
    Change in the level of functional flexibility of lower extremity assessed using Chair Sit and Stand Test (CSST) at 6 weeks.
    Description
    assesses the functional flexibility of the lower extremity in adult (23). Participant sits on the edge of a chair. One foot must remain flat on the floor. The other leg is extended forward with the knee straight, heel on the floor, and ankle bent at 90°. Patients place one hand on top of the other with tips of the middle fingers even. Patients keep the knee straight, and hold the reach for 2 seconds. If the fingertips touch the toes then the score is zero (0). If they do not touch, measure the distance between the fingers and the toes (a negative score/-), if they overlap, measure by how much (a positive score/+) and recorded in cm.
    Time Frame
    At the beginning and at the end of 6 weeks
    Title
    Change in the level of functional flexibility of upper extremity assessed using Back Scratch Test (BST) at 6 weeks.
    Description
    Back Scratch Test (BST)(cm) evaluates the functional flexibility of the patient's upper extremity. Patients are asked to rotate their shoulder externally with palms facing their back. Their hand fingers extend while trying to reach the lowest point, the other arm internally rotates while trying to reach the highest point. Patients are asked their fingertips to be closer to each other. If finger tips do not touch each other, the distance between them is recorded in cm assumed as a negative score, if the fingertips touch each other, then the score is assumed as zero. If they overlap, it is recorded in cm taking as positive score. Three repetitions are performed consecutively and the best score was recorded.
    Time Frame
    At the beginning and at the end of 6 weeks
    Title
    Change in the level of quality of life assessed using Quality of Life Questionnaire of the European Foundation for Osteoporosis (QUALEFFO-41) at 6 weeks
    Description
    A. Quality of Life Questionnaire of the European Foundation for Osteoporosis (QUALEFFO-41) examine the five dimensions of health such as pain, physical functioning, social activities, general health assessment and mental function of patients with osteoporosis. Quality of Life Questionnaire of the European Foundation for Osteoporosis (QUALEFFO-41) was filled by the patients and score was calculated as percentage (%).
    Time Frame
    At the beginning and at the end of 6 weeks
    Title
    Change in the level of anxiety and depression assessed using Hospital Anxiety And Depression Scale (HADS) at 6 weeks
    Description
    This scale was filled by the patients. It has no special units. The elevation of the total score indicates the increased anxiety and depression levels (score out of 42).
    Time Frame
    At the beginning and at the end of 6 weeks
    Title
    Change in the level of chronic functional impairment assessed using Health Assessment Questionnaire (HAQ) at 6 weeks
    Description
    Health Assessment Questionnaire (HAQ) (score out of 24) is commonly used for evaluating the patients' chronic functional impairment caused by rheumatic diseases. This questionnaire was filled by the patients and it has no special units.
    Time Frame
    At the beginning and at the end of 6 weeks
    Title
    Change in the level of life satisfaction assessed using Satisfaction with Life Scale (SLS) at 6 weeks
    Description
    This scale (score out of 35) was filled by the patients. It has no special units.
    Time Frame
    At the beginning and at the end of 6 weeks

    10. Eligibility

    Sex
    Female
    Minimum Age & Unit of Time
    50 Years
    Maximum Age & Unit of Time
    75 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Woman diagnosed with osteoporosis between the ages 50-75 within the last year Exclusion Criteria History of fractures Joint replacements or fixation of the joints at the lower extremities or the spine Any neurological or muscle diseases Inability to continuously attend the exercise program Any secondary diseases resulting in decreased mobility or functional status Visual, hearing or mental problems that could prevent communication

    12. IPD Sharing Statement

    Plan to Share IPD
    Undecided

    Learn more about this trial

    Effect Of Exercises On Kinesiophobia, And Other Symptoms Related to Osteoporosis

    We'll reach out to this number within 24 hrs