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Motivational Interventions and Physical Exercise in Patients With Fragility Fracture (PREVFRAILTY)

Primary Purpose

Fragility Fracture

Status

Recruiting

Phase

Not Applicable

Locations

Spain

Study Type

Interventional

Intervention

Physical and motivational follow-up treatment

Usual care

About this trial

This is an interventional treatment trial for Fragility Fracture focused on measuring fragility fracture, physical exercise, motivational intervention

Eligibility Criteria

50 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Present a hip fracture (includes cervical fracture and trochanteric), classified in the 10th version of the International Classification of Diseases (ICD-10-ES) with codes S72-S72.26X;
In addition, the fracture must be due to fragility: fracture due to a low-energy trauma or not proportional to the consequences (Hermoso de Mendoza, 2003);
To have received a surgical repair by replacement arthroplasty or internal fixation (ICD-10-ES procedures: 0SU and 0SR) in a period of less than one week;
To be recovering in a trauma and orthopedic unit and/or be transferred to a rehabilitation unit or discharged;
Before the fracture, independent or mild dependence for activities of daily living (Barthel index> 60) and living at home;
To have the cognitive ability to give informed consent (ANNEX I);
To live and be domiciled in a basic health area covered by the study hospital complex
To be over 50 years of age

Exclusion Criteria:

Presence of low cognitive level (scores below 23 points in Lobo's Mini-cognitive exam);
Patients with pathological fractures due to skeletal alterations other than osteoporosis;
Presence of more than one fall (other than the cause of hospital admission) in the last year;
Presence of uncorrected anemia (hemoglobin concentration <9/dL), acute infectious disease (C-reactive protein> 10 mg / L), severe cardiorespiratory disease (for example: unstable angina; severe heart failure identified by the New York Heart Association as class III-IV), musculoskeletal or neurological diseases (for example, major amputation of lower limbs) that make physical exercise impossible.

Sites / Locations

Maimónides Biomedical Research Institute of CórdobaRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Physical activity program and motivational intervention

Treatment as usual

Arm Description

Physical activity program agreed with the patient / family and according to functional status (based on the 6-minute walk test) and motivational intervention. In addition to the care provided in usual care, a progressive physical exercise program based on basal functional capacity is prescribed. The exercise will be developed at home.

Multidisciplinary rehabilitation provided by professionals in the hospital and primary care settings, according to the individual needs of patients at different times of their recovery and the accessibility and availability of services in the different care settings.

Outcomes

Primary Outcome Measures

Barthel index

Functional status for the development of activities of daily living (individual ability to take care of himself)

Number of hospital readmissions

Other clinical outcomes, such as mortality and all-cause hospitalization,

Secondary Outcome Measures

Mini-Mental State Examination

A 30-point questionnaire that is used extensively in clinical and research settings to measure cognitive impairment

Minnesota Leisure Time Physical Activity Questionnaire

To assess the quantity (total activity metabolic index) and quality (heavy, moderate, and light) of physical activity performed

Geriatric Depression Scale

is a brief, 30-item questionnaire in which participants are asked to respond by answering yes or no in reference to how they felt over the past week

Visual analogue scale

A validated, subjective measure for acute and chronic pain

Falls Efficacy Scale-International

It is a 16 item questionnaire, useful to the researchers and clinicians interested in fear of falling, with a score ranging from minimum 16 (no concern about falling) to maximum 64 (severe concern about falling)

5-level EQ-5D version

A standardised measure of health-related quality of life

Full Information

NCT ID

NCT04934358

First Posted

June 14, 2021

Last Updated

March 2, 2023

Sponsor

Maimónides Biomedical Research Institute of Córdoba

1. Study Identification

Unique Protocol Identification Number

NCT04934358

Brief Title

Motivational Interventions and Physical Exercise in Patients With Fragility Fracture

Acronym

PREVFRAILTY

Official Title

Effectiveness of a Follow-up Program Based on Motivational Interventions and Physical Exercise in Patients With Fragility Fracture: Randomized Controlled Clinical Trial.

Study Type

Interventional

2. Study Status

Record Verification Date

March 2023

Overall Recruitment Status

Recruiting

Study Start Date

January 10, 2022 (Actual)

Primary Completion Date

December 31, 2022 (Actual)

Study Completion Date

December 31, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Maimónides Biomedical Research Institute of Córdoba

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

Brief Summary

Patients with a fragility fracture are twice as likely to have future fractures compared to their non-fractured peers. Furthermore, the 30% who suffer a fragility fracture do not regain the level of functioning in terms of activities of daily living after one year. A recent ecological study, in several European countries, estimates that if fracture patients were enrolled in fracture follow-up services, at least 19,000 fractures could be prevented each year. Clinical trials carried out in the research group have shown that the prescription of physical exercise in severe underlying pathologies is effective in improving physical function, quality of life and long-term results. Hypothesis: The implementation of a motivational intervention and physical exercise program, in a staggered manner, taking into account the basic exercise capacity, improves the functional status of the patient (basic activities of daily life), adherence to interventions and the level of physical activity, and therefore reduces the number of hospital admissions, refractures and other associated complications. Objective: To evaluate the effect of a rehabilitation intervention based on physical exercise and motivation, applied in a staggered manner and according to the functional capacity of patients with fragility fracture.

Detailed Description

Method: Single-blind, randomized, controlled clinical study, with 2 parallel arms and single-center. Study subjects: Patients who underwent surgery for a fragility hip fracture between September 2021 and September 2022 in a tertiary hospital in southern Spain. A progressive physical exercise and motivational intervention adjusted for functional capacity will be compared versus usual rehabilitation care. Follow-up of patients for 3 months and a final visit at 6 months. The primary outcome variables will be functional status for the development of activities of daily living (individual ability to care for himself) and number of hospital readmissions (reasons and consequences). Variables related to quality of life, cognitive status, laboratory markers and densitometry will also be analyzed.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Fragility Fracture

Keywords

fragility fracture, physical exercise, motivational intervention

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Model Description

Parallel Assignment

Masking

Investigator

Masking Description

Single (Investigator)

Allocation

Randomized

Enrollment

100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Physical activity program and motivational intervention

Arm Type

Experimental

Arm Description

Arm Title

Treatment as usual

Arm Type

Active Comparator

Arm Description

Intervention Type

Behavioral

Intervention Name(s)

Physical and motivational follow-up treatment

Intervention Description

Physical and motivational follow-up treatment

Intervention Type

Behavioral

Intervention Name(s)

Usual care

Intervention Description

Usual rehabilitation program

Primary Outcome Measure Information:

Title

Barthel index

Description

Functional status for the development of activities of daily living (individual ability to take care of himself)

Time Frame

6 months

Title

Number of hospital readmissions

Description

Other clinical outcomes, such as mortality and all-cause hospitalization,

Time Frame

6 months

Secondary Outcome Measure Information:

Title

Mini-Mental State Examination

Description

A 30-point questionnaire that is used extensively in clinical and research settings to measure cognitive impairment

Time Frame

6 months

Title

Minnesota Leisure Time Physical Activity Questionnaire

Description

To assess the quantity (total activity metabolic index) and quality (heavy, moderate, and light) of physical activity performed

Time Frame

6 months

Title

Geriatric Depression Scale

Description

is a brief, 30-item questionnaire in which participants are asked to respond by answering yes or no in reference to how they felt over the past week

Time Frame

6 months

Title

Visual analogue scale

Description

A validated, subjective measure for acute and chronic pain

Time Frame

6 months

Title

Falls Efficacy Scale-International

Description

Time Frame

6 months

Title

5-level EQ-5D version

Description

A standardised measure of health-related quality of life

Time Frame

6 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

50 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Present a hip fracture (includes cervical fracture and trochanteric), classified in the 10th version of the International Classification of Diseases (ICD-10-ES) with codes S72-S72.26X; In addition, the fracture must be due to fragility: fracture due to a low-energy trauma or not proportional to the consequences (Hermoso de Mendoza, 2003); To have received a surgical repair by replacement arthroplasty or internal fixation (ICD-10-ES procedures: 0SU and 0SR) in a period of less than one week; To be recovering in a trauma and orthopedic unit and/or be transferred to a rehabilitation unit or discharged; Before the fracture, independent or mild dependence for activities of daily living (Barthel index> 60) and living at home; To have the cognitive ability to give informed consent (ANNEX I); To live and be domiciled in a basic health area covered by the study hospital complex To be over 50 years of age Exclusion Criteria: Presence of low cognitive level (scores below 23 points in Lobo's Mini-cognitive exam); Patients with pathological fractures due to skeletal alterations other than osteoporosis; Presence of more than one fall (other than the cause of hospital admission) in the last year; Presence of uncorrected anemia (hemoglobin concentration <9/dL), acute infectious disease (C-reactive protein> 10 mg / L), severe cardiorespiratory disease (for example: unstable angina; severe heart failure identified by the New York Heart Association as class III-IV), musculoskeletal or neurological diseases (for example, major amputation of lower limbs) that make physical exercise impossible.

Facility Information:

Facility Name

Maimónides Biomedical Research Institute of Córdoba

City

Córdoba

State/Province

Cordoba

ZIP/Postal Code

14004

Country

Spain

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Antonio Luque

Phone

0034671596070

uicec@imibic.org

First Name & Middle Initial & Last Name & Degree

Pablo Jesús López Soto, PhD

12. IPD Sharing Statement

Plan to Share IPD

Undecided

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Motivational Interventions and Physical Exercise in Patients With Fragility Fracture

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