Osteoporotic Vertebral Fractures and Exercise

NCT05521724 | Unknown DMC

• 1 other identifier: HasanKU-YASEMİNSALKİN-1992
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Exercise Addiction; Vertebral Fracture

Keywords

exercise; geriatrics; vertebral fracture; pain

Outcome Measures

Primary Outcomes (2)

• 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

• 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 Outcomes (7)

• Physical Performance Assessment

  within 1 week of study completion (average 12 weeks)

• Quality of Life Assessment

  within 1 week of study completion (average 12 weeks)

• Depression Assessment

  within 1 week of study completion (average 12 weeks)

• Loss of Function Assessment

  within 1 week of study completion (average 12 weeks)

• Kinesiophobia Assessment

  within 1 week of study completion (average 12 weeks)

Study Arms (2)

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.

Procedure: exercise

control group

ACTIVE COMPARATOR

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

Procedure: exercise

Interventions

exercise PROCEDURE

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

control group; exercise group

Eligibility Criteria

• Age: 55 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Ambulatory,
• 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).

You may not qualify if:

• 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

Sponsors & Collaborators

• Hasan Kalyoncu University: lead

Study Sites (1)

Mersin Üniversitesi

Mersin, Yeni̇şehi̇r/mersi̇n, 33120, Turkey (Türkiye)

RECRUITING

Related Publications (3)

• 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.

  PMID: 31273764 BACKGROUND

• 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.

  PMID: 31456562 BACKGROUND

• 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.

  PMID: 24281053 RESULT

Related Links

• ARTICLE 1
• ARTICLE 2
• ARTICLE 3

MeSH Terms

Conditions

Spinal Fractures; Motor Activity; Pain

Interventions

Exercise

Condition Hierarchy (Ancestors)

Spinal Injuries; Back Injuries; Wounds and Injuries; Fractures, Bone; Behavior; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Central Study Contacts

YASEMİN SALKIN

CONTACT

0505 116 53 13; yaseminsalkin@mersin.edu.tr

Pınar Müge ALTINKAYA, DR

CONTACT

0506 730 86 98; pmsarikaya@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: LECTURER

Model Details: randomized controlled clinical trial

Study Record Dates

• First Submitted: August 24, 2022
• First Posted: August 30, 2022
• Study Start: August 20, 2022
• Primary Completion: November 1, 2022
• Study Completion: December 1, 2022
• Last Updated: August 30, 2022

Record last verified: 2022-08

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)