Fragility FracturePREVFRAILTYNCT04934358
Motivational Interventions and Physical Exercise in Patients With Fragility Fracture
A study testing Physical and motivational follow-up treatment in people with Fragility Fracture, run by Maimónides Biomedical Research Institute of Córdoba at 1 site in Spain.
Trial 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. Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Fragility Fracture
- What is being tested?
- Physical and motivational follow-up treatment
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteSpain
- Study dates
- 10 Jan 2022to 31 Dec 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Spain1 site
Maimónides Biomedical Research Institute of Córdoba
Córdoba, Cordoba, 14004
About this study
Official title: Effectiveness of a Follow-up Program Based on Motivational Interventions and Physical Exercise in Patients With Fragility Fracture: Randomized Controlled Clinical Trial.
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.
Read the 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.
- Conditions
- Fragility Fracture
- Being tested
- Physical and motivational follow-up treatment, Usual care
- Keywords
- fragility fracture, physical exercise, motivational intervention
- Medical subject headings
- Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Physical and motivational follow-up treatmentBehavioural
Physical and motivational follow-up treatment
Usual careBehavioural
Usual rehabilitation program
| Study group | Role | What they receive |
|---|---|---|
| Physical activity program and motivational intervention | Experimental | 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. Receives: Behavioral: Physical and motivational follow-up treatment |
| Treatment as usual | Active comparator | 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. Receives: Behavioral: Usual care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Barthel index
Functional status for the development of activities of daily living (individual ability to take care of himself)
Measured: 6 months
Number of hospital readmissions
Other clinical outcomes, such as mortality and all-cause hospitalization,
Measured: 6 months
Secondary outcomes (6)
Mini-Mental State Examination
A 30-point questionnaire that is used extensively in clinical and research settings to measure cognitive impairment
Measured: 6 months
Minnesota Leisure Time Physical Activity Questionnaire
To assess the quantity (total activity metabolic index) and quality (heavy, moderate, and light) of physical activity performed
Measured: 6 months
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
Measured: 6 months
Visual analogue scale
A validated, subjective measure for acute and chronic pain
Measured: 6 months
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)
Measured: 6 months
5-level EQ-5D version
A standardised measure of health-related quality of life
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jun 2021
- Study start10 Jan 2022
- Primary completion31 Dec 2022
- Study completion31 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Fragility FractureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Parallel Assignment
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Maimónides Biomedical Research Institute of Córdoba
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04934358
- Sponsor's protocol ID
- PIGE-0040-2020
- Acronym
- PREVFRAILTY
- Status last verified
- Apr 2024
- First submitted
- 14 Jun 2021
- Last updated
- 6 Nov 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Segura-Ruiz R, Ruiz-Canete M, Munoz-Alonso A, Rivas-Cruces C, Serrano-Lazaro P, Armenteros-Ortiz PJ, Hidalgo-Lopezosa P, Lamberti N, Manfredini F, Lopez-Soto PJ. Effectiveness of a home-based physical exercise intervention in patients with fragility fractures on functional independence and hospital readmissions: a protocol for a randomised controlled trial. BMJ Open. 2025 Nov 4;15(11):e101342. doi: 10.1136/bmjopen-2025-101342.
PubMed 41248369
Study at a glance
From the registry record, last updated by the sponsor on 6 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of a Follow-up Program Based on Motivational Interventions and Physical Exercise in Patients With Fragility Fracture: Randomized Controlled Clinical Trial.
- ClinicalTrials.gov ID
- NCT04934358
- Acronym / sponsor ID
- PREVFRAILTY / PIGE-0040-2020
- Conditions
- Fragility Fracture
- Keywords
- fragility fracture, physical exercise, motivational intervention
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Maimónides Biomedical Research Institute of CórdobaUniversity, hospital or other
- Study start
- 10 Jan 2022 (actual)
- Primary completion
- 31 Dec 2022 (actual)
- Study completion
- 31 Dec 2024 (actual)
- First posted
- 22 Jun 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
- Model description
- Parallel Assignment
| Arm | Type | Receives |
|---|---|---|
| Physical activity program and motivational intervention | Experimental | Behavioral: Physical and motivational follow-up treatmentPhysical 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. |
| Treatment as usual | Active comparator | Behavioral: Usual careMultidisciplinary 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. |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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;
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Physical and motivational follow-up treatmentPhysical and motivational follow-up treatment | Behavioural | Physical activity program and motivational intervention |
| Usual careUsual rehabilitation program | Behavioural | Treatment as usual |
Primary outcome
Barthel index
Time frame: 6 months
Functional status for the development of activities of daily living (individual ability to take care of himself)
Number of hospital readmissions
Time frame: 6 months
Other clinical outcomes, such as mortality and all-cause hospitalization,
6 secondary outcomes
Mini-Mental State Examination
Time frame: 6 months
Minnesota Leisure Time Physical Activity Questionnaire
Time frame: 6 months
Geriatric Depression Scale
Time frame: 6 months
Visual analogue scale
Time frame: 6 months
Falls Efficacy Scale-International
Time frame: 6 months
5-level EQ-5D version
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Nov 2026.
- Derived from this study: PubMed 41248369Segura-Ruiz R, Ruiz-Canete M, Munoz-Alonso A, Rivas-Cruces C, Serrano-Lazaro P, Armenteros-Ortiz PJ, Hidalgo-Lopezosa P, Lamberti N, Manfredini F, Lopez-Soto PJ. Effectiveness of a home-based physical exercise intervention in patients with fragility fractures on functional independence and hospital readmissions: a protocol for a randomised controlled trial. BMJ Open. 2025 Nov 4;15(11):e101342. doi: 10.1136/bmjopen-2025-101342.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Physical and motivational follow-up treatment in people with Fragility Fracture, run by Maimónides Biomedical Research Institute of Córdoba at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Barthel index (time frame: 6 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04934358, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Nov 2026.