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Postoperative Intervention Program Effectiveness in Hip Fracture Patients: A Randomized Clinical Trial

NCT03156075 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 124

Last updated 2017-05-19

No results posted yet for this study

Summary

The aim of the study is to investigate whether a simple intervention improves the physical functioning and reduce mortality after surgery for elderly hip fracture patients in a period of one year follow up. We hypothesized that the postoperative intervention program decreases the mortality in one year and improves mobility.

This study is a randomized controlled trial designed as a prospective intervention and a historical control group from the previous three months admitted operated hip fracture patients from another study and with bone mineral density and measurement of weight and height done. The study will include patients of both sexes, 50 years and older, after their approval to participate and applying exclusion criteria. A baseline assessment will be done for the included hip fracture patients, who will be admitted to Trauma Unit of Assiut University Hospitals and will be surgically treated for a period of 1 year. The exclusion criteria include patients with major accidents, polytrauma, pathological fractures and bilateral hip fractures. Also patients with thyroid malfunctions, renal diseases, cardiac diseases, long term immobilization, liver diseases and musculoskeletal disorders. Two well-trained nurses will carry out the personal interviews in the Trauma Unit ward with each patient and/or patients 'relatives using a structured questionnaire. Data collection will be done after providing informed consent.

Bone mineral density, weight and height for every patient will be done. The follow up phone calls will be done for every patient at 3 months, 6 months and one year postoperative.

Intervention group:

Patients in the intervention Group will be provided with postoperative health education intervention program, which includes nutrition education for improving general and bone health and physical exercise training for the patient and his relative before discharge.

This group will receive the usual care prior to the start of intervention and participating in the study.

The phone calls will include questions about: if the patient is alive or not. If not, subsequent detailed questions about causes and timing of death will be filled in.

If the patient is alive, subsequent questions about nutrition, commodities and physical activity will be filled in. Assessment of physical activity will be done by the Western Ontario And McMaster Universities Osteoarthritis Index (WOMAC).

Conditions

  • Hip Fractures

Interventions

BEHAVIORAL

Nutrition and exercise program

Nutrition education will be about increasing the intake calcium and vitamin D rich foods and exposure to sun will provided for the intervention group. Education of the patients about exercises that increases the strength of lower limb and hip muscles to increase the mobility of the patients earlier and decrease the mortality in turn.

Sponsors & Collaborators

  • Dalia Mahran

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
50 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-07-31
Primary Completion
2015-12-31
Completion
2015-12-31

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03156075 on ClinicalTrials.gov