Clinical trial NCT02716844: 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
Overall status: COMPLETED
Phase: NA
Conditions: Osteoporosis
Keywords: Osteoporosis
Clinic Pilates Exercise
Kinesiophobia
Pain
Lead sponsor: Eastern Mediterranean University
Sponsor class: OTHER
First posted: 2016-03-23
Enrollment: 47
Sex: FEMALE
Minimum age (years): 50
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Change in the level of fear and avoidance associated with movement assessed using the Tampa Kinesiophobia Scale at 6 weeks
timeFrame: At the beginning and at the end of 6 weeks
Secondary outcomes:
measure: Change in the level of pain intensity in the morning assessed using Visual Analogue Scale (VAS) at 6 weeks.
timeFrame: At the beginning and at the end of 6 weeks
measure: Change in the level of pain intensity during activity assessed using Visual Analogue Scale (VAS) at 6 weeks.
timeFrame: At the beginning and at the end of 6 weeks
measure: Change in the level of pain intensity at rest assessed using Visual Analogue Scale (VAS) at 6 weeks.
timeFrame: At the beginning and at the end of 6 weeks
measure: Change in the level of experienced pain assessed with using Short Form - McGill Pain Questionnaire (SF-McGill)
timeFrame: At the beginning and at the end of 6 weeks
measure: Change in the level of influence of patients' general pain intensity on their daily life activities and functionality assessed using Pain Disability Index (PDI).
timeFrame: At the beginning and at the end of 6 weeks
measure: 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)
timeFrame: At the beginning and at the end of 6 weeks
measure: Change in the level of functional balance assessed using Berg Balance Test (BBT).
timeFrame: At the beginning and at the end of 6 weeks
measure: Change in the level of functional balance assessed using The Timed Up and Go Test (TUG).
timeFrame: At the beginning and at the end of 6 weeks
measure: Change in the level of lower extremity proximal muscle's strength and endurance assessed using Chair Sit and Stand Test (CSST) at 6 weeks.
timeFrame: At the beginning and at the end of 6 weeks
measure: Change in the level of functional flexibility of lower extremity assessed using Chair Sit and Stand Test (CSST) at 6 weeks.
timeFrame: At the beginning and at the end of 6 weeks
measure: Change in the level of functional flexibility of upper extremity assessed using Back Scratch Test (BST) at 6 weeks.
timeFrame: At the beginning and at the end of 6 weeks
measure: 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
timeFrame: At the beginning and at the end of 6 weeks
measure: Change in the level of anxiety and depression assessed using Hospital Anxiety And Depression Scale (HADS) at 6 weeks
timeFrame: At the beginning and at the end of 6 weeks
measure: Change in the level of chronic functional impairment assessed using Health Assessment Questionnaire (HAQ) at 6 weeks
timeFrame: At the beginning and at the end of 6 weeks
measure: Change in the level of life satisfaction assessed using Satisfaction with Life Scale (SLS) at 6 weeks
timeFrame: At the beginning and at the end of 6 weeks
Other outcomes:
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