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Osteoporotic Vertebral Fractures and Exercise

H

Hasan Kalyoncu University

Status

Enrolling

Conditions

Exercise Addiction
Vertebral Fracture

Treatments

Procedure: exercise

Study type

Interventional

Funder types

Other

Identifiers

NCT05521724
HasanKU-YASEMİNSALKİN-1992

Details and patient eligibility

About

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.

Full 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.

Enrollment

40 estimated patients

Sex

All

Ages

55+ years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Triple Blind

40 participants in 2 patient groups

exercise group
Experimental group
Description:
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.
Treatment:
Procedure: exercise
control group
Active Comparator group
Description:
No intervention will be made to the control group during the study.
Treatment:
Procedure: exercise

Trial contacts and locations

1

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Central trial contact

Pınar Müge ALTINKAYA, DR; YASEMİN SALKIN

Data sourced from clinicaltrials.gov

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