Clinical trial NCT05521724: Osteoporotic Vertebral Fractures and Exercise
Official title: The Effect of Exercise Training on Individuals With Osteoporotic Vertebral Fractures
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Exercise Addiction
Vertebral Fracture
Keywords: exercise
geriatrics
vertebral fracture
pain
Lead sponsor: Hasan Kalyoncu University
Sponsor class: OTHER
First posted: 2022-08-30
Enrollment: 40
Sex: ALL
Minimum age (years): 55
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: randomized controlled clinical trial
Primary purpose: TREATMENT

Brief 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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Pain Assessment
timeFrame: A day before the treatment
measure: Pain Assessment
timeFrame: within 1 week of study completion (average 12 weeks)
Secondary outcomes:
measure: Physical Performance Assessment
timeFrame: within 1 week of study completion (average 12 weeks)
measure: Quality of Life Assessment
timeFrame: within 1 week of study completion (average 12 weeks)
measure: Depression Assessment
timeFrame: within 1 week of study completion (average 12 weeks)
measure: Loss of Function Assessment
timeFrame: within 1 week of study completion (average 12 weeks)
measure: Kinesiophobia Assessment
timeFrame: within 1 week of study completion (average 12 weeks)
measure: Sleep Quality Assessment
timeFrame: within 1 week of study completion (average 12 weeks)
measure: Sleepiness State Assessment
timeFrame: within 1 week of study completion (average 12 weeks)
Other outcomes:
Locations:
city: Mersin
country: Turkey
facility: Mersin Üniversitesi
state: Yeni̇şehi̇r/mersi̇n
Study officials:
References:
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(7):CD008618. doi: 10.1002/14651858.CD008618.pub3.
citation: 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.
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. Osteoporos Int. 2014 Mar;25(3):821-35. doi: 10.1007/s00198-013-2523-2. Epub 2013 Nov 27.