Osteoporotic Vertebral Fractures and Exercise

Vertebral Fracture Clinical Trial

Official title:

The Effect of Exercise Training on Individuals With Osteoporotic Vertebral Fractures

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05521724
• Other study ID #: HasanKU-YASEMINSALKIN-1992
• Status: Recruiting
• Phase: N/A
• Start date: August 20, 2022
• Est. completion date: December 1, 2022

Study information

• Verified date: August 2022
• Source: Hasan Kalyoncu University
• Contact: YASEMIN SALKIN
• Phone: 0505 116 53 13
• Email: yaseminsalkin[@]mersin.edu.tr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Physiotherapy has an important place in the treatment of osteoporotic vertebral fractures. Therapeutic exercise is often recommended for patients with vertebral fractures to reduce pain and restore functional movement. There is not enough evidence in the literature to determine the effects of long-term exercise on osteoporotic fractures and their side effects. Therefore, the aim of this study is to evaluate the effectiveness of 12-week exercise training in patients with osteoporotic vertebral fractures.

Description:

Osteoporotic vertebral fractures are associated with increased morbidity (eg, pain, poor quality of life) and mortality. Therapeutic exercise is a conservative non-pharmacological treatment that is often recommended for patients with vertebral fractures to reduce pain and restore functional movement. There are preliminary studies showing that exercise may have an important role in improving quality of life and reducing the risk of re-fracture in these individuals. There are several reports of pain relief after short-term (6-10 weeks) exercise programs in people with spinal fractures, suggesting that there is uncertainty in the effects reported after longer-term (12-24 weeks) exercise. Data are scarce and there are only four studies examining this question, and one is a multi-component physical therapy intervention that includes exercise. Not all studies have examined individuals with severe pain at baseline. The quality assessment of the evidence for the effects of exercise on pain is very low. There is insufficient evidence in the literature to determine the effects of exercise on osteoporotic fractures and their side effects. Therefore, the aim of the study is to evaluate the effectiveness of 12-week resistance and balance exercises in patients with osteoporotic vertebral fractures.The group of patients who will exercise will be compared with individuals who do not receive any treatment or exercise. It is aimed to reveal the effects of exercise on pain, physical performance, quality of life, depression, loss of function, kinesiophobia and sleep quality.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: December 1, 2022
• Est. primary completion date: November 1, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 55 Years and older

Eligibility

Inclusion Criteria:

• Ambulatory,
• 55 years and over,
• A minimum pain score of 3 in the Short Form Mc-Gill, which we will use for pain assessment.
• Able to use mobile phone by himself or with the support of his family,
• Having at least one vertebral fracture at least 6 months ago as a result of X-ray,
• It was defined as having osteoporosis (Lumbar spine DEXA T score <-2.5).

Exclusion Criteria:

• Metabolic disease that will prevent participation in exercise,
• Pain at a level that prevents participation in exercise (a score above 7 in Short Form Mc Gill)
• Severe cardiovascular or pulmonary diseases (such as Uncontrolled Hypertension, resting heart rate 100 beats/min),
• Psychiatric diseases
• Determined as a recent fracture history

Related Conditions & MeSH terms

• Exercise Addiction
• Fractures, Bone
• Spinal Fractures
• Vertebral Fracture

Intervention

Procedure:
• exercise
resistance and strengthening exercises will be applied to a randomized patient group.

Locations

Country	Name	City	State
Turkey	Mersin Üniversitesi	Mersin	Yeni?sehi?r/mersi?n

Sponsors (1)

Lead Sponsor	Collaborator
Hasan Kalyoncu University

Country where clinical trial is conducted

Turkey, 

References & Publications (3)

Barker KL, Newman M, Stallard N, Leal J, Minns Lowe C, Javaid MK, Noufaily A, Adhikari A, Hughes T, Smith DJ, Gandhi V, Cooper C, Lamb SE. Exercise or manual physiotherapy compared with a single session of physiotherapy for osteoporotic vertebral fracture: three-arm PROVE RCT. Health Technol Assess. 2019 Aug;23(44):1-318. doi: 10.3310/hta23440. — View Citation

Giangregorio LM, Papaioannou A, Macintyre NJ, Ashe MC, Heinonen A, Shipp K, Wark J, McGill S, Keller H, Jain R, Laprade J, Cheung AM. Too Fit To Fracture: exercise recommendations for individuals with osteoporosis or osteoporotic vertebral fracture. Osteo — View Citation

Gibbs JC, MacIntyre NJ, Ponzano M, Templeton JA, Thabane L, Papaioannou A, Giangregorio LM. Exercise for improving outcomes after osteoporotic vertebral fracture. Cochrane Database Syst Rev. 2019 Jul 5;7:CD008618. doi: 10.1002/14651858.CD008618.pub3. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pain Assessment	The assessment of low back pain will be performed with the Short Form McGill Pain Scale. The form consists of three parts. In the first part, there are 15 descriptive word groups. Of these, 11 evaluate the sensory dimension of the pain, and 4 evaluate the perceptual dimension. These descriptors are rated on an intensity scale from 0 to 3 (0= none, 1= Mild, 2=Moderate, 3= Excess). In the first part of the scale, a total of 3 pain scores are obtained: sensory pain score, perceptual pain score and total pain score. In the second part of the form, there are five word groups ranging from "mild pain" to "unbearable pain" to determine the severity of the patient's pain. In the third part, the current pain intensity of the patient is evaluated using a visual comparison scale.	A day before the treatment
Primary	Pain Assessment	The assessment of low back pain will be performed with the Short Form McGill Pain Scale. The form consists of three parts. In the first part, there are 15 descriptive word groups. Of these, 11 evaluate the sensory dimension of the pain, and 4 evaluate the perceptual dimension. These descriptors are rated on an intensity scale from 0 to 3 (0= none, 1= Mild, 2=Moderate, 3= Excess). In the first part of the scale, a total of 3 pain scores are obtained: sensory pain score, perceptual pain score and total pain score. In the second part of the form, there are five word groups ranging from "mild pain" to "unbearable pain" to determine the severity of the patient's pain. In the third part, the current pain intensity of the patient is evaluated using a visual comparison scale.	within 1 week of study completion (average 12 weeks)
Secondary	Physical Performance Assessment	A 6 Minute Walk Test will be used. It is a functional walking capacity test in which patients walk at their own pace. Patients walk as far as they can in a straight corridor in six minutes. Standardized commands and words of encouragement are used. Primary endpoint: Six-minute walk.	within 1 week of study completion (average 12 weeks)
Secondary	Quality of Life Assessment	The European Osteoporosis Foundation Quality of Life Questionnaire-41 will be used to assess patients' quality of life.; The European Osteoporosis Foundation Quality of Life Questionnaire-41, such as pain (5 items), physical function (17 items), social activity (7 items), general health assessment (3 items) and mental function (9 items); It consists of 5 subscales that examine the five dimensions of health. The answers to the questions in the QUALEFFO-41 scale are scored from 1 (healthy) to 5 (unhealthy), respectively. The section score and the total score are calculated by transferring the scores to a measurement out of 100. For each subgroup and overall outcome in the scale, 0 points indicate the best health status, while 100 points indicate the worst health status.	within 1 week of study completion (average 12 weeks)
Secondary	Depression Assessment	Beck Depression Scale will be used to evaluate the depression of the patients. The Beck Depression Scale consists of 21 questions questioning behavior and feelings related to the general depressive state. A high score indicates increased depressive symptom severity. It was developed to measure the risk of depression, the level of depressive symptoms and the change in severity in adults. Turkish validity and reliability study was done by Hisli. It contains a total of 21 self-evaluation sentences. Each item receives an increasing score between 0-3 and the total varies between 0-63. In the validity and reliability article of the scale for Turkish, the cut-off point was accepted as 17. Scores of eighteen and above are considered to be indicative of moderate and severe depression.	within 1 week of study completion (average 12 weeks)
Secondary	Loss of Function Assessment	The Oswestry Disability Index will be used to assess the degree of loss of function due to low back pain. The Turkish validity and reliability of the Oswestry Disability Index, which was demonstrated in 2004, consists of 10 items. The items question the severity of pain, self-care, lifting-carrying, walking, sitting, standing, sleep, the degree of change in pain, travel and social life. Under each item, there are six statements that the patient marked as appropriate for his/her condition. The first statement is scored as "0" and the sixth statement is scored as "5". When the total score is calculated, it is multiplied by two and expressed as a percentage. The maximum score is "100", the minimum score is "0". As the total score increases, the level of disability also increases.	within 1 week of study completion (average 12 weeks)
Secondary	Kinesiophobia Assessment	The Tampa Kinesiophobia Scale, which is based on the fear of avoidance due to fear constituting pain-based movement limitation, fear in work-related activities, fear of movement or re-injury, and the Turkish version of the scale and the reliability study of the scale, will be used in the assessment of kinesiophobia. The Tampa kinesiophobia scale is a 17-item scale developed to measure the fear of movement or re-injury. The scale includes parameters of injury/re-injury and fear-avoidance in work-related activities. A 4-point Likert scoring (1=strongly disagree, 4=strongly agree) is used in the scale. After reversing items 4, 8, 12 and 16, a total score is calculated. In this evaluation, the individual gets a score between 17-68. A high score on the scale indicates that kinesiophobia is also high.	within 1 week of study completion (average 12 weeks)
Secondary	Sleep Quality Assessment	It will be evaluated by the Pittsburgh Sleep Quality Index. The Pittsburgh Sleep Quality Index is a 19-item self-report scale that assesses sleep quality and impairment over the past month. It consists of 24 questions, 19 questions are self-report questions, 5 questions are questions to be answered by the spouse or roommate. The 18 scored questions of the scale consist of 7 components. Subjective Sleep Quality, Sleep Latency, Sleep Duration, Habitual Sleep Efficiency, Sleep Disorder, Sleeping Drug Use, and Daytime Dysfunction. Each component is evaluated over 0-3 points. The total score of the 7 components gives the scale total score. The total score ranges from 0 to 21. A total score greater than 5 indicates "poor sleep quality"	within 1 week of study completion (average 12 weeks)
Secondary	Sleepiness State Assessment	Sleepiness will be evaluated with the Epworth Sleepiness Scale. It is a simple, easy-to-understand, 8-item scale with proven validity and reliability in assessing the general sleepiness level in adults. In the survey, participants are asked to evaluate the probability of falling asleep during the activities they do during the day, although not every day, and evaluate them on a scale of 0 to 3. The questionnaire consists of a total of 8 situations. While the score between 0-9 obtained as a result of the survey is considered as normal, the score between 10-24 indicates that the expert should be consulted. Scores between 11 and 15 indicate mild to moderate sleep apnea, while scores of 16 and above indicate severe sleep apnea or narcolepsy.	within 1 week of study completion (average 12 weeks)

External Links

•   ARTICLE 1
•   ARTICLE 2
•   ARTICLE 3