EUCTR2017-001543-13-DK
Active, not recruiting
Phase 1
Preliminary effect and safety of physiotherapy with strength training and protein-dense nutritional supplement in combination with anabolic steroids in cross-continuum rehabilitation of patients with hip fracture - a randomized controlled pilot trial. (The HIP-SAP trial) - HIP-SAP trial
Morten Tange Kristensen/Hvidovre Hospital0 sites48 target enrollmentFebruary 1, 2018
ConditionsArea of investigation is recovery of muscle strength and function following hip fracture surgery.MedDRA version: 20.1Level: LLTClassification code 10017287Term: Fractured hipSystem Organ Class: 100000004863MedDRA version: 20.1Level: LLTClassification code 10017299Term: Fractured neck of femurSystem Organ Class: 100000004863MedDRA version: 20.1Level: LLTClassification code 10034736Term: Pertrochanteric fracture of femur, closedSystem Organ Class: 100000004863MedDRA version: 20.1Level: LLTClassification code 10053653Term: Femur fracture subtrochantericSystem Organ Class: 100000004863Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]
DrugsDeca-Durabolin
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Area of investigation is recovery of muscle strength and function following hip fracture surgery.
- Sponsor
- Morten Tange Kristensen/Hvidovre Hospital
- Enrollment
- 48
- Status
- Active, not recruiting
- Last Updated
- 5 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Patients who have undergone surgery for a hip fracture at Amager\-Hvidovre University Hospital and admitted at the Hip Fracture Unit at the hospital
- •Age \>\=65 years
- •Ability to speak and understand Danish and with a Danish Social Security Number
- •Able to give written informed consent
- •Residing at home and with an independent pre\-fracture indoor walking ability (NMS\=2\)
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1\.2 Adults (18\-64 years) no
- •F.1\.2\.1 Number of subjects for this age range
- •F.1\.3 Elderly (\>\=65 years) yes
Exclusion Criteria
- •Postoperative weight\-bearing restrictions
- •Multiple fractures
- •Terminal illness
- •Patients unable/unwilling to cooperate on testing and rehabilitation
- •Planned/elective hospitalization within the trial period.
- •Cognitive dysfunction determined by chart review, reported by nursing staff, or observed by trained research staff (not alert or oriented, dementia, active delirium)
- •Uncontrolled blood pressure (systolic \> 150 mmHg, or diastolic \> 100 mmHg)
- •Heart disease in the form of peri\-, myo\- or endocarditis.
- •History of stroke with motor disability.
- •Heart failure (NYHA class III and IV)
Outcomes
Primary Outcomes
Not specified
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