OsteoporosisNCT02716844
Effect Of Exercises On Kinesiophobia, And Other Symptoms Related to Osteoporosis
A study testing Exercise in people with Osteoporosis, run by Eastern Mediterranean University.
Trial 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. Read more about this study
- Who is it for?
- Ages 50 to 75 years, women only
- Conditions the study is for
- Osteoporosis
- What is being tested?
- Exercise
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 47 participants
- Where
- No sites listed yet
- Study dates
- Jan 2015to Mar 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 to 75 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Woman diagnosed with osteoporosis between the ages 50-75 within the last year
Who cannot join
- 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
About this study
Official title: The Effect Of The Clinical Pilates Exercises On Kinesiophobia, And Other Symptoms Related to Osteoporosis
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.
- Conditions
- Osteoporosis
- Being tested
- Exercise
- Keywords
- Osteoporosis, Clinic Pilates Exercise, Kinesiophobia, Pain
- Medical subject headings
- Osteoporosis, Kinesiophobia, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ExerciseOther
Clinical Pilates exercise were given for 6 weeks, 3 days in a week
| Study group | Role | What they receive |
|---|---|---|
| Exercise Group, | Experimental | Clinical Pilates exercise were given for 6 weeks, 3 days in a week Receives: Other: Exercise |
| Control Group | No intervention | Nothing given to control group, told to continue their normal life for 6 weeks. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: At the beginning and at the end of 6 weeks
Secondary outcomes (15)
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).
Measured: At the beginning and at the end of 6 weeks
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).
Measured: At the beginning and at the end of 6 weeks
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).
Measured: At the beginning and at the end of 6 weeks
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.
Measured: At the beginning and at the end of 6 weeks
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.
Measured: At the beginning and at the end of 6 weeks
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 .
Measured: At the beginning and at the end of 6 weeks
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.
Measured: At the beginning and at the end of 6 weeks
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).
Measured: At the beginning and at the end of 6 weeks
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.
Measured: At the beginning and at the end of 6 weeks
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.
Measured: At the beginning and at the end of 6 weeks
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.
Measured: At the beginning and at the end of 6 weeks
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
- 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 (%).
Measured: At the beginning and at the end of 6 weeks
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).
Measured: At the beginning and at the end of 6 weeks
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.
Measured: At the beginning and at the end of 6 weeks
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.
Measured: At the beginning and at the end of 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Mar 2016 (estimated)
- Study startJan 2015
- Primary completionMar 2016
- Study completionMar 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for OsteoporosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 47 participants (actual)
Sponsor and investigators
- Lead sponsor
- Eastern Mediterranean University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sevim Öksüz, Eastern Mediterranean University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02716844
- Sponsor's protocol ID
- LUT11/16,B:30.2.HAC.0.20.05.04
- Status last verified
- Mar 2016
- First submitted
- 3 Mar 2016
- Last updated
- 24 Mar 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 24 Mar 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect Of The Clinical Pilates Exercises On Kinesiophobia, And Other Symptoms Related to Osteoporosis
- ClinicalTrials.gov ID
- NCT02716844
- Acronym / sponsor ID
- LUT11/16,B:30.2.HAC.0.20.05.04
- Conditions
- Osteoporosis
- Keywords
- Osteoporosis, Clinic Pilates Exercise, Kinesiophobia, Pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 47 participants (actual)
- Lead sponsor
- Eastern Mediterranean UniversityUniversity, hospital or other
- Study start
- Jan 2015
- Primary completion
- Mar 2016 (actual)
- Study completion
- Mar 2016 (actual)
- First posted
- 23 Mar 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Exercise Group, | Experimental | Other: ExerciseClinical Pilates exercise were given for 6 weeks, 3 days in a week |
| Control Group | No intervention | –Nothing given to control group, told to continue their normal life for 6 weeks. |
Who may qualify
- Ages
- 50 to 75 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Woman diagnosed with osteoporosis between the ages 50-75 within the last year
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ExerciseClinical Pilates exercise were given for 6 weeks, 3 days in a week | Other | Exercise Group, |
Primary outcome
Change in the level of fear and avoidance associated with movement assessed using the Tampa Kinesiophobia Scale at 6 weeks
Time frame: At the beginning and at the end of 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.
15 secondary outcomes
Change in the level of pain intensity in the morning assessed using Visual Analogue Scale (VAS) at 6 weeks.
Time frame: At the beginning and at the end of 6 weeks
Change in the level of pain intensity during activity assessed using Visual Analogue Scale (VAS) at 6 weeks.
Time frame: At the beginning and at the end of 6 weeks
Change in the level of pain intensity at rest assessed using Visual Analogue Scale (VAS) at 6 weeks.
Time frame: At the beginning and at the end of 6 weeks
Change in the level of experienced pain assessed with using Short Form - McGill Pain Questionnaire (SF-McGill)
Time frame: At the beginning and at the end of 6 weeks
Change in the level of influence of patients' general pain intensity on their daily life activities and functionality assessed using Pain Disability Index (PDI).
Time frame: At the beginning and at the end of 6 weeks
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)
Time frame: At the beginning and at the end of 6 weeks
Change in the level of functional balance assessed using Berg Balance Test (BBT).
Time frame: At the beginning and at the end of 6 weeks
Change in the level of functional balance assessed using The Timed Up and Go Test (TUG).
Time frame: At the beginning and at the end of 6 weeks
Change in the level of lower extremity proximal muscle's strength and endurance assessed using Chair Sit and Stand Test (CSST) at 6 weeks.
Time frame: At the beginning and at the end of 6 weeks
Change in the level of functional flexibility of lower extremity assessed using Chair Sit and Stand Test (CSST) at 6 weeks.
Time frame: At the beginning and at the end of 6 weeks
Change in the level of functional flexibility of upper extremity assessed using Back Scratch Test (BST) at 6 weeks.
Time frame: At the beginning and at the end of 6 weeks
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
Time frame: At the beginning and at the end of 6 weeks
Change in the level of anxiety and depression assessed using Hospital Anxiety And Depression Scale (HADS) at 6 weeks
Time frame: At the beginning and at the end of 6 weeks
Change in the level of chronic functional impairment assessed using Health Assessment Questionnaire (HAQ) at 6 weeks
Time frame: At the beginning and at the end of 6 weeks
Change in the level of life satisfaction assessed using Satisfaction with Life Scale (SLS) at 6 weeks
Time frame: At the beginning and at the end of 6 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Mar 2016.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Exercise in people with Osteoporosis, run by Eastern Mediterranean University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Mar 2016. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in the level of fear and avoidance associated with movement assessed using the Tampa Kinesiophobia Scale at 6 weeks (time frame: At the beginning and at the end of 6 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Mar 2016.