Osteoporotic Vertebral Fractures and Exercise

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-08-20

Study Completion Date

2022-12-01

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Study of Effect of Exercise With Osteoporosis and Vertebral Fracture

NCT01120197

Osteoporosis Vertebral Fracture

COMPLETED NA

Investigation of the Effects of Physical Activity in Women at Risk of Osteoporosis

NCT06081764

Osteoporosis Risk

COMPLETED NA

Osteosarcopenia and Exercise

NCT04526327

Sarcopenia Osteoporosis, Osteopenia

COMPLETED NA

The Effect of Exercise on Physical Function in Older Women With Osteoporosis and a History of Vertebral Fracture

NCT02781974

Osteoporosis Vertebral Fractures

COMPLETED NA

Build Better Bones With Exercise

NCT01761084

Osteoporotic Fractures Spinal Fractures

COMPLETED NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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

See the medical conditions and disease areas that this research is targeting or investigating.

Exercise Addiction Vertebral Fracture

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

randomized controlled clinical trial

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

exercise group

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.

Group Type EXPERIMENTAL

exercise

Intervention Type PROCEDURE

resistance and strengthening exercises will be applied to a randomized patient group.

control group

No intervention will be made to the control group during the study.

Group Type ACTIVE_COMPARATOR

exercise

Intervention Type PROCEDURE

resistance and strengthening exercises will be applied to a randomized patient group.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

exercise

resistance and strengthening exercises will be applied to a randomized patient group.

Intervention Type PROCEDURE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

Minimum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No