Exercise AddictionNCT05521724
Osteoporotic Vertebral Fractures and Exercise
A study testing exercise in people with Exercise Addiction and Vertebral Fracture, run by Hasan Kalyoncu University at 1 site in Turkey (Türkiye).
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. Read more about this study
- Who is it for?
- Ages 55 years and older
- Conditions the study is for
- Exercise Addiction, Vertebral Fracture
- What is being tested?
- exercise
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 20 Aug 2022to 1 Dec 2022
- 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 55 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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).
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Mersin Üniversitesi
Mersin, Yeni̇şehi̇r/mersi̇n, 33120
YASEMİN SALKIN, 05051165313 ext. 70019, yaseminsalkin@mersin.edu.tr
ZERRİN PELİN, PROF.DR
About this study
Official title: The Effect of Exercise Training on Individuals With Osteoporotic Vertebral Fractures
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.
Read the detailed 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.
- Conditions
- Exercise Addiction, Vertebral Fracture
- Being tested
- exercise
- Keywords
- exercise, geriatrics, vertebral fracture, pain
- Medical subject headings
- Spinal Fractures, Motor Activity, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
exerciseProcedure or surgery
resistance and strengthening exercises will be applied to a randomized patient group.
| Study group | Role | What they receive |
|---|---|---|
| exercise group | Experimental | The exercise protocol includes balance training and resistance training for all major muscle groups. The program will be performed twice a week.
* Squat
* Step up
* Step-up sideways
* Upright row
* Chest presS
* Biceps curl In balance exercises; It will start with static balance exercises and progress to dynamic balance exercises and will be applied 2 days a week for a minimum of 15 minutes.
* Tandem stance
* Semitandem stance
* Standing exercises on one leg will be performed first with eyes open and then with eyes closed.
As dynamic balance exercises;
* Just tip toe walking
* Don't just walk on heels
* Tandem walking is selected. Receives: Procedure: exercise |
| control group | Active comparator | No intervention will be made to the control group during the study. Receives: Procedure: exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: A day before the treatment
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.
Measured: within 1 week of study completion (average 12 weeks)
Secondary outcomes (7)
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.
Measured: within 1 week of study completion (average 12 weeks)
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.
Measured: within 1 week of study completion (average 12 weeks)
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.
Measured: within 1 week of study completion (average 12 weeks)
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.
Measured: within 1 week of study completion (average 12 weeks)
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.
Measured: within 1 week of study completion (average 12 weeks)
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"
Measured: within 1 week of study completion (average 12 weeks)
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.
Measured: within 1 week of study completion (average 12 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Aug 2022
- Study start20 Aug 2022
- Primary completion1 Nov 2022 (estimated)
- Study completion1 Dec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Exercise AddictionStudies 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
- Model description
- randomized controlled clinical trial
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hasan Kalyoncu University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yasemin Salkin, Hasan Kalyoncu University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05521724
- Sponsor's protocol ID
- HasanKU-YASEMİNSALKİN-1992
- Status last verified
- Aug 2022
- First submitted
- 24 Aug 2022
- Last updated
- 30 Aug 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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(7):CD008618. doi: 10.1002/14651858.CD008618.pub3.
PubMed 31273764Barker 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.
PubMed 31456562Giangregorio 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. Osteoporos Int. 2014 Mar;25(3):821-35. doi: 10.1007/s00198-013-2523-2. Epub 2013 Nov 27.
PubMed 24281053
Study at a glance
From the registry record, last updated by the sponsor on 30 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Exercise Training on Individuals With Osteoporotic Vertebral Fractures
- ClinicalTrials.gov ID
- NCT05521724
- Acronym / sponsor ID
- HasanKU-YASEMİNSALKİN-1992
- Conditions
- Exercise Addiction, Vertebral Fracture
- Keywords
- exercise, geriatrics, vertebral fracture, pain
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Hasan Kalyoncu UniversityUniversity, hospital or other
- Study start
- 20 Aug 2022 (actual)
- Primary completion
- 1 Nov 2022 (estimated)
- Study completion
- 1 Dec 2022 (estimated)
- First posted
- 30 Aug 2022 (actual)
- 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.
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.
Detailed 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- randomized controlled clinical trial
| Arm | Type | Receives |
|---|---|---|
| exercise group | Experimental | Procedure: exerciseThe exercise protocol includes balance training and resistance training for all major muscle groups. The program will be performed twice a week. * Squat * Step up * Step-up sideways * Upright row * Chest presS * Biceps curl In balance exercises; It will start with static balance exercises and progress to dynamic balance exercises and will be applied 2 days a week for a minimum of 15 minutes. * Tandem stance * Semitandem stance * Standing exercises on one leg will be performed first with eyes open and then with eyes closed. As dynamic balance exercises; * Just tip toe walking * Don't just walk on heels * Tandem walking is selected. |
| control group | Active comparator | Procedure: exerciseNo intervention will be made to the control group during the study. |
Who may qualify
- Ages
- 55 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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,
Key exclusion criteria (5 listed)
- 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
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 |
|---|---|---|
| exerciseresistance and strengthening exercises will be applied to a randomized patient group. | Procedure or surgery | control group, exercise group |
Primary outcome
Pain Assessment
Time frame: A day before the treatment
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.
Pain Assessment
Time frame: within 1 week of study completion (average 12 weeks)
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.
7 secondary outcomes
Physical Performance Assessment
Time frame: within 1 week of study completion (average 12 weeks)
Quality of Life Assessment
Time frame: within 1 week of study completion (average 12 weeks)
Depression Assessment
Time frame: within 1 week of study completion (average 12 weeks)
Loss of Function Assessment
Time frame: within 1 week of study completion (average 12 weeks)
Kinesiophobia Assessment
Time frame: within 1 week of study completion (average 12 weeks)
Sleep Quality Assessment
Time frame: within 1 week of study completion (average 12 weeks)
Sleepiness State Assessment
Time frame: within 1 week of study completion (average 12 weeks)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Aug 2022.
- Background: PubMed 31273764Gibbs 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(7):CD008618. doi: 10.1002/14651858.CD008618.pub3.
- Background: PubMed 31456562Barker 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.
- Results publication: PubMed 24281053Giangregorio 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. Osteoporos Int. 2014 Mar;25(3):821-35. doi: 10.1007/s00198-013-2523-2. Epub 2013 Nov 27.
- ARTICLE 1Link provided by the sponsor.
- ARTICLE 2Link provided by the sponsor.
- ARTICLE 3Link provided by the sponsor.
- Individual participant dataSharing planned: No
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing exercise in people with Exercise Addiction and Vertebral Fracture, run by Hasan Kalyoncu University at 1 site in Turkey (Türkiye).
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 6 inclusion and 5 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: status not confirmed, as of the sponsor's last update on 30 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact YASEMİN SALKIN (0505 116 53 13, yaseminsalkin@mersin.edu.tr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain Assessment (time frame: A day before the treatment). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05521724, which also lists 3 linked publications.
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 30 Aug 2022.