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

NCT03156075 | Completed

• 1 other identifier: 17300078
• Study Type: interventional
• Target: 124
• Locations: 0 countries
• Sites: N/A

Brief 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

Keywords

hip fracture, intervention, mortality, mobility

Outcome Measures

Primary Outcomes (1)

• Mortality

  Postoperative hip fracture mortality of the patients

  immediately postoperative to one year after operation

Secondary Outcomes (1)

• Mobility

  from three months to one year postoperative

Study Arms (2)

Intervention group

EXPERIMENTAL

This group will receive the nutrition and exercise program intervention. 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. and the first one will start before discharge. The patients will receive a leaflet to describe the instructions.

Behavioral: Nutrition and exercise program

Control group

NO INTERVENTION

This group will be selected from the previous three months, they didn't receive any intervention and received the usual care postoperative.

Interventions

Nutrition and exercise program BEHAVIORAL

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.

Intervention group

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• All patients postoperative hip fracture from 50 years and above from both sexes and admitted to Trauma Unit at Assiut University Hospitals

You may not qualify if:

• 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.

Sponsors & Collaborators

• Dalia Mahran: lead

MeSH Terms

Conditions

Hip Fractures

Interventions

Nutritional Status

Condition Hierarchy (Ancestors)

Femoral Fractures; Fractures, Bone; Wounds and Injuries; Hip Injuries; Leg Injuries

Intervention Hierarchy (Ancestors)

Nutritional Physiological Phenomena; Diet, Food, and Nutrition; Physiological Phenomena; Health Status; Demography; Population Characteristics

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Assistant professor

Study Record Dates

• First Submitted: May 15, 2017
• First Posted: May 17, 2017
• Study Start: July 1, 2014
• Primary Completion: December 1, 2015
• Study Completion: December 1, 2015
• Last Updated: May 19, 2017

Record last verified: 2017-05

Data Sharing

• IPD Sharing: Will not share