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Physiotherapy, Nutritional Supplement and Anabolic Steroids in Rehabilitation of Patients With Hip Fracture. (HIP-SAP)

Primary Purpose

Hip Fractures

Status
Completed
Phase
Phase 2
Locations
Denmark
Study Type
Interventional
Intervention
Nandrolone Decanoate
Protein-rich nutritional supplement
Physical therapy
Sodium Chloride 9mg/ml Injection
Sponsored by
Morten Tange Kristensen PT, PhD
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Hip Fractures focused on measuring Rehabilitation, Physiotherapy, Strength training, Anabolic steroids, Nutritional supplement

Eligibility Criteria

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

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 >=60 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)

Exclusion Criteria:

  • Postoperative weight-bearing restrictions
  • Multiple fractures
  • Active cancer or suspected pathological fracture
  • Patients unable/unwilling to cooperate to 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 (disoriented, 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)
  • Evidence of kidney failure or renal impairment (estimated glomerular filtration rate < 30 mL/min/1.73 m2 or serum creatinine >200μmol/L)
  • Abnormal liver function tests (alanine aminotransferase, γ-glutamyltransferase, bilirubin, or alkaline phosphatase >2 times the upper limit of normal) or history of hepatic tumor.
  • Elevated hematocrit ≥ 50%
  • History of breast or prostate cancer
  • Abnormally elevated serum PSA assesed at the 3 week control corresponding to PSA < 4.0 µg/L (60-70 years), PSA < 5.0 µg/L (>70 years).
  • Allergic to any ingredient in the Deca-Durabolin solution (Nandrolone, benzyl alcohol, arachis oil (peanut-oil) and allergy to peanuts or soya) or milk protein allergy (related to the nutritional drink).

Sites / Locations

  • Hvidovre Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Nandrolone Decanoate

Placebo (Sodium Chloride)

Arm Description

Physical therapy with strength training, protein-rich nutritional supplement plus Nandrolone decanoate.

Physical therapy with strength training, protein-rich nutritional supplement plus placebo.

Outcomes

Primary Outcome Measures

Change in maximal isometric knee-extension strength (Nm/Kg) in the fractured limb.
Measured using a belt fixed handheld dynamometer.

Secondary Outcome Measures

Maximal isometric knee-extension strength (Nm/Kg) in the fractured limb in % of the non-fractured limb
Measured using a belt fixed handheld dynamometer.
Maximal isometric knee-extension strength (Nm/Kg) in the non-fractured limb.
Measured using a belt fixed handheld dynamometer.
Hand-grip strength in the dominant hand.
Measured using a handheld dynamometer, expressed in kg.
Bone mineral density (BMD)
Registration of total body, total hip, femoral neck, lumbar spine. Assessed by Dual-energy X-ray absorptiometry (DEXA), expressed in g/cm2. Further the T-score is registered. The DEXA is conducted in accordance with the department's standard procedures.
Lean body mass (LBM)
Registration of total body, legs bilaterally, arms bilaterally. Assessed by DEXA and expressed in kg.
Fat mass
Total body. Assessed by DEXA and expressed in kg.
Nutrition screening using the Mini Nutritional Assessment Short Form (MNA-SF).
Total score from 0-14 points, high scores indicating better nutritional status
Gait speed will be assessed using the 10 meter walk test (10mWT)
The results reported in meters walked per second (m/s).
Timed up and go test (TUG)
Performed using a 4 wheeled rollator and measured in seconds. The patient has to rise from a chair, walk 3 meters, turnaround, walk back and sit down.
The de Mortons Mobility Index (DEMMI)
Measures mobility and consists of 15 mobility items ranging from mobility in bed to dynamic balance. The test results in a total score from 0 to 100 with 100 representing the highest level of mobility.
Upright time
Assessed by using a body-worn accelerometer-based activity monitor (ActivePAL). The monitor will be attached to the thigh. The patient will wear the monitor for 7 days.
Functional level is assessed by the New Mobility Score (NMS).
The patients are interviewed about walking ability indoor, outdoor and when shopping. the week prior to hospital admission. The total score range from 0 to 9. A Higher score indicating higher independence.
The EQ-5D-3L is used for assessing health related quality of life.
It is administered via interview.
Hip fracture related pain at rest and during outcome assessment
It is evaluated by Verbal Ranking Scale (VRS). The patient expresses pain levels on a verbal scale from 0-4, higher score indicating higher pain levels.
Global Rating of Change Scale
Assessment of patient perceived change in walking ability during the trial period.
The Short Falls Efficacy Scale-International (Short FES-I)
Measures the patient's fear of falling (Score 7-28, higher scores indicating a higher fear of falling). It is administered as an interview.
Fatigue is assessed using the Short Form (36) Health Survey (SF36) vitality subscale.
The scale consists of 4 items related to fatigue/energy. Score range from 0-100 points; high score defines a more favorable health state. Administered as an interview.
Depression is assessed using the Geriatric Depression Scale (GDS-15)
Administered as an interview. Score range 0-15.
Re-admissions
Assessed through the medical journal/interviews.
Residential status (including home care)
Change in residential status and home care (help provided in the patients home). Assessed through the medical journal/interviews.
Mortality
Assessed through the medical journal/Danish civil register.
Falls
Number of falls. Assessed through interviews
Total testosterone (nmol/l)
Blood test
Luteinizing hormone (LH), IU/l
Blood test
Follicle-stimulating hormone (FSH) IU/l
Blood test
Sex hormone binding globulin (SHBG), nmol/l
Blood test
Lipid profile (Total cholesterol, HDL cholesterol, LDL cholesterol, triglyceride) mmol/l.
Blood test
C-reactive protein (CRP), mg/l.
Blood test
Hematocrit (B-Erythrocyte, vol.fr.)
Safety parameter, blood test
Hemoglobin
Safety parameter, blood test
Creatinine
Safety parameter, blood test
Carbamide
Safety parameter, blood test
Sodium (Na+)
Safety parameter, blood test
Potassium (K+)
Safety parameter, blood test
Calcium
Safety parameter, blood test
Liver tests (Albumin, Alanine aminotransferase (ALAT), γ-glutamyltransferase, Bilirubin)
Safety parameter, blood test
International Normalized Ratio (INR)
Safety parameter, blood test
Prostate Specific Antigen (PSA)
Safety parameter, blood test
Glucose
Safety parameter, blood test
Blood pressure
Safety parameter, assessed using a 'Blood pressure monitor' (mmHg).
Facial hirsutism
Change in facial hair assessed using the 2 face-related items of Ferriman-Galway Hirsutism Score.
Hoarseness
Change in voice, reported by patient or observed by interviewer (no specific score available for this evaluation).
Other adverse events
Assessed through interview, observation
Edema in non-fractured leg
Change in edema assessed through interview

Full Information

First Posted
May 18, 2018
Last Updated
February 9, 2021
Sponsor
Morten Tange Kristensen PT, PhD
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1. Study Identification

Unique Protocol Identification Number
NCT03545347
Brief Title
Physiotherapy, Nutritional Supplement and Anabolic Steroids in Rehabilitation of Patients With Hip Fracture.
Acronym
HIP-SAP
Official Title
Preliminary Effect and Safety of Physiotherapy With Strength Training and Protein-rich 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)
Study Type
Interventional

2. Study Status

Record Verification Date
February 2021
Overall Recruitment Status
Completed
Study Start Date
September 3, 2018 (Actual)
Primary Completion Date
May 20, 2020 (Actual)
Study Completion Date
June 3, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Morten Tange Kristensen PT, PhD

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
This pilot trial investigates the preliminary effect and safety of a 12 week multi-modal intervention initiated during admission in the acute ward after hip fracture surgery. The intervention under investigation is a combination therapy consisting of physiotherapy, protein-rich nutritional supplement and nandrolone decanoate (Deca-Durabolin) supplement. The investigators expect the combination therapy to be a preliminary effective and safe treatment in elderly patients with hip fracture and that this combination therapy intervention program is more efficacious in improving muscle strength, and physical function 14 weeks after hip fracture surgery, compared to physiotherapy, protein-rich nutritional supplement plus placebo.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hip Fractures
Keywords
Rehabilitation, Physiotherapy, Strength training, Anabolic steroids, Nutritional supplement

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
29 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Nandrolone Decanoate
Arm Type
Experimental
Arm Description
Physical therapy with strength training, protein-rich nutritional supplement plus Nandrolone decanoate.
Arm Title
Placebo (Sodium Chloride)
Arm Type
Placebo Comparator
Arm Description
Physical therapy with strength training, protein-rich nutritional supplement plus placebo.
Intervention Type
Drug
Intervention Name(s)
Nandrolone Decanoate
Other Intervention Name(s)
Deca-durabolin, anabolic steroid
Intervention Description
Injections every 3 weeks, last injection at week 12. Women 50 mg, men with total testosterone ≥ 11 nmol/l will receive 100 mg, and men with total testosterone < 11 nmol/l will receive a dose of 200 mg.
Intervention Type
Dietary Supplement
Intervention Name(s)
Protein-rich nutritional supplement
Other Intervention Name(s)
Nestle Resource fiber 2.0
Intervention Description
The protein-rich nutritional supplement is a liquid containing 18 g milk-based protein pr bottle. Patients will receive a minimum of 1.35 g/kg bodyweight/day); which means that most patients will receive 2 bottles per day for 12 weeks.
Intervention Type
Other
Intervention Name(s)
Physical therapy
Other Intervention Name(s)
Physiotherapy
Intervention Description
The physical therapy intervention will include progressive strength training initiated daily on weekdays during hospitalization and continued twice per week in the outpatient rehabilitation program in the municipality (treatment as usual but with strength training as an obligatory component) for a total intervention period of 12 weeks from time of inclusion.
Intervention Type
Drug
Intervention Name(s)
Sodium Chloride 9mg/ml Injection
Other Intervention Name(s)
Saline
Intervention Description
Placebo injection of 1 ml Sodium Chloride
Primary Outcome Measure Information:
Title
Change in maximal isometric knee-extension strength (Nm/Kg) in the fractured limb.
Description
Measured using a belt fixed handheld dynamometer.
Time Frame
Baseline and 14 weeks after inclusion
Secondary Outcome Measure Information:
Title
Maximal isometric knee-extension strength (Nm/Kg) in the fractured limb in % of the non-fractured limb
Description
Measured using a belt fixed handheld dynamometer.
Time Frame
Baseline and 14 weeks after inclusion
Title
Maximal isometric knee-extension strength (Nm/Kg) in the non-fractured limb.
Description
Measured using a belt fixed handheld dynamometer.
Time Frame
Baseline and 14 weeks after inclusion.
Title
Hand-grip strength in the dominant hand.
Description
Measured using a handheld dynamometer, expressed in kg.
Time Frame
Baseline and 14 weeks after inclusion.
Title
Bone mineral density (BMD)
Description
Registration of total body, total hip, femoral neck, lumbar spine. Assessed by Dual-energy X-ray absorptiometry (DEXA), expressed in g/cm2. Further the T-score is registered. The DEXA is conducted in accordance with the department's standard procedures.
Time Frame
Baseline and 14 weeks after inclusion.
Title
Lean body mass (LBM)
Description
Registration of total body, legs bilaterally, arms bilaterally. Assessed by DEXA and expressed in kg.
Time Frame
Baseline and 14 weeks after inclusion.
Title
Fat mass
Description
Total body. Assessed by DEXA and expressed in kg.
Time Frame
Baseline and 14 weeks after inclusion.
Title
Nutrition screening using the Mini Nutritional Assessment Short Form (MNA-SF).
Description
Total score from 0-14 points, high scores indicating better nutritional status
Time Frame
Baseline (prefracture) and 14 weeks after inclusion.
Title
Gait speed will be assessed using the 10 meter walk test (10mWT)
Description
The results reported in meters walked per second (m/s).
Time Frame
Baseline and 14 weeks after inclusion.
Title
Timed up and go test (TUG)
Description
Performed using a 4 wheeled rollator and measured in seconds. The patient has to rise from a chair, walk 3 meters, turnaround, walk back and sit down.
Time Frame
Baseline and 14 weeks after inclusion.
Title
The de Mortons Mobility Index (DEMMI)
Description
Measures mobility and consists of 15 mobility items ranging from mobility in bed to dynamic balance. The test results in a total score from 0 to 100 with 100 representing the highest level of mobility.
Time Frame
Baseline and 14 weeks after inclusion.
Title
Upright time
Description
Assessed by using a body-worn accelerometer-based activity monitor (ActivePAL). The monitor will be attached to the thigh. The patient will wear the monitor for 7 days.
Time Frame
Measured from the time of the control week 12 and one week ahead.
Title
Functional level is assessed by the New Mobility Score (NMS).
Description
The patients are interviewed about walking ability indoor, outdoor and when shopping. the week prior to hospital admission. The total score range from 0 to 9. A Higher score indicating higher independence.
Time Frame
Baseline (prefracture) and 3/6/9/12/14 weeks after inclusion.
Title
The EQ-5D-3L is used for assessing health related quality of life.
Description
It is administered via interview.
Time Frame
Baseline (prefracture) and 14 weeks after inclusion
Title
Hip fracture related pain at rest and during outcome assessment
Description
It is evaluated by Verbal Ranking Scale (VRS). The patient expresses pain levels on a verbal scale from 0-4, higher score indicating higher pain levels.
Time Frame
Baseline and 3/6/9/12/14 weeks after inclusion.
Title
Global Rating of Change Scale
Description
Assessment of patient perceived change in walking ability during the trial period.
Time Frame
Baseline, and 3/6/9/12/14 weeks after inclusion.
Title
The Short Falls Efficacy Scale-International (Short FES-I)
Description
Measures the patient's fear of falling (Score 7-28, higher scores indicating a higher fear of falling). It is administered as an interview.
Time Frame
Baseline and 14 weeks after inclusion.
Title
Fatigue is assessed using the Short Form (36) Health Survey (SF36) vitality subscale.
Description
The scale consists of 4 items related to fatigue/energy. Score range from 0-100 points; high score defines a more favorable health state. Administered as an interview.
Time Frame
Baseline (prefracture), and 3/6/9/12/14 weeks after inclusion.
Title
Depression is assessed using the Geriatric Depression Scale (GDS-15)
Description
Administered as an interview. Score range 0-15.
Time Frame
Baseline (prefracture) and 14 weeks after inclusion.
Title
Re-admissions
Description
Assessed through the medical journal/interviews.
Time Frame
14 weeks after inclusion.
Title
Residential status (including home care)
Description
Change in residential status and home care (help provided in the patients home). Assessed through the medical journal/interviews.
Time Frame
Baseline (prefracture) and 14 weeks after inclusion.
Title
Mortality
Description
Assessed through the medical journal/Danish civil register.
Time Frame
14 weeks after inclusion.
Title
Falls
Description
Number of falls. Assessed through interviews
Time Frame
Assessed through weekly telephone interviews and hospital visits at 3/6/9/12/14 weeks after inclusion.
Title
Total testosterone (nmol/l)
Description
Blood test
Time Frame
Baseline and 14 weeks after inclusion.
Title
Luteinizing hormone (LH), IU/l
Description
Blood test
Time Frame
Baseline and 14 weeks after inclusion.
Title
Follicle-stimulating hormone (FSH) IU/l
Description
Blood test
Time Frame
Baseline and 14 weeks after inclusion.
Title
Sex hormone binding globulin (SHBG), nmol/l
Description
Blood test
Time Frame
Baseline and 14 weeks after inclusion.
Title
Lipid profile (Total cholesterol, HDL cholesterol, LDL cholesterol, triglyceride) mmol/l.
Description
Blood test
Time Frame
Baseline and 14 weeks after inclusion.
Title
C-reactive protein (CRP), mg/l.
Description
Blood test
Time Frame
Baseline and 14 weeks after inclusion.
Title
Hematocrit (B-Erythrocyte, vol.fr.)
Description
Safety parameter, blood test
Time Frame
Baseline, and 3/6/9/12/14 weeks after inclusion.
Title
Hemoglobin
Description
Safety parameter, blood test
Time Frame
Baseline, and 3/6/9/12/14 weeks after inclusion.
Title
Creatinine
Description
Safety parameter, blood test
Time Frame
Baseline, and 3/6/9/12/14 weeks after inclusion.
Title
Carbamide
Description
Safety parameter, blood test
Time Frame
Baseline, and 3/6/9/12/14 weeks after inclusion.
Title
Sodium (Na+)
Description
Safety parameter, blood test
Time Frame
Baseline, and 3/6/9/12/14 weeks after inclusion.
Title
Potassium (K+)
Description
Safety parameter, blood test
Time Frame
Baseline, and 3/6/9/12/14 weeks after inclusion.
Title
Calcium
Description
Safety parameter, blood test
Time Frame
Baseline, and 3/6/9/12/14 weeks after inclusion.
Title
Liver tests (Albumin, Alanine aminotransferase (ALAT), γ-glutamyltransferase, Bilirubin)
Description
Safety parameter, blood test
Time Frame
Baseline, and 3/6/9/12/14 weeks after inclusion.
Title
International Normalized Ratio (INR)
Description
Safety parameter, blood test
Time Frame
Baseline, and 3/6/9/12/14 weeks after inclusion.
Title
Prostate Specific Antigen (PSA)
Description
Safety parameter, blood test
Time Frame
Baseline, and 3/6/9/12/14 weeks after inclusion.
Title
Glucose
Description
Safety parameter, blood test
Time Frame
Baseline, and 3/6/9/12/14 weeks after inclusion.
Title
Blood pressure
Description
Safety parameter, assessed using a 'Blood pressure monitor' (mmHg).
Time Frame
Baseline, and 3/6/9/12/14 weeks after inclusion.
Title
Facial hirsutism
Description
Change in facial hair assessed using the 2 face-related items of Ferriman-Galway Hirsutism Score.
Time Frame
Baseline, and 3/6/9/12/14 weeks after inclusion.
Title
Hoarseness
Description
Change in voice, reported by patient or observed by interviewer (no specific score available for this evaluation).
Time Frame
Assessed at baseline and through weekly telephone interviews and hospital visits at 3/6/9/12/14 weeks after inclusion.
Title
Other adverse events
Description
Assessed through interview, observation
Time Frame
Assessed through weekly interviews and hospital visits at 3/6/9/12/14 weeks after inclusion.
Title
Edema in non-fractured leg
Description
Change in edema assessed through interview
Time Frame
Assessed at baseline and through weekly interviews and hospital visits at 3/6/9/12/14 weeks after inclusion.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
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 >=60 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) Exclusion Criteria: Postoperative weight-bearing restrictions Multiple fractures Active cancer or suspected pathological fracture Patients unable/unwilling to cooperate to 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 (disoriented, 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) Evidence of kidney failure or renal impairment (estimated glomerular filtration rate < 30 mL/min/1.73 m2 or serum creatinine >200μmol/L) Abnormal liver function tests (alanine aminotransferase, γ-glutamyltransferase, bilirubin, or alkaline phosphatase >2 times the upper limit of normal) or history of hepatic tumor. Elevated hematocrit ≥ 50% History of breast or prostate cancer Abnormally elevated serum PSA assesed at the 3 week control corresponding to PSA < 4.0 µg/L (60-70 years), PSA < 5.0 µg/L (>70 years). Allergic to any ingredient in the Deca-Durabolin solution (Nandrolone, benzyl alcohol, arachis oil (peanut-oil) and allergy to peanuts or soya) or milk protein allergy (related to the nutritional drink).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Morten T Kristensen, PT, PhD
Organizational Affiliation
Department of Occupational and Physical Therapy and Department of Orthopedic Surgery, Amager-Hvidovre University Hospital
Official's Role
Study Director
Facility Information:
Facility Name
Hvidovre Hospital
City
Hvidovre
ZIP/Postal Code
2650
Country
Denmark

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
34016037
Citation
Hulsbaek S, Bandholm T, Ban I, Foss NB, Jensen JB, Kehlet H, Kristensen MT. Feasibility and preliminary effect of anabolic steroids in addition to strength training and nutritional supplement in rehabilitation of patients with hip fracture: a randomized controlled pilot trial (HIP-SAP1 trial). BMC Geriatr. 2021 May 20;21(1):323. doi: 10.1186/s12877-021-02273-z.
Results Reference
derived
PubMed Identifier
31870451
Citation
Hulsbaek S, Ban I, Aasvang TK, Jensen JB, Kehlet H, Foss NB, Bandholm T, Kristensen MT. Preliminary effect and feasibility of physiotherapy with strength training and protein-rich nutritional supplement in combination with anabolic steroids in cross-continuum rehabilitation of patients with hip fracture: protocol for a blinded randomized controlled pilot trial (HIP-SAP1 trial). Trials. 2019 Dec 23;20(1):763. doi: 10.1186/s13063-019-3845-y.
Results Reference
derived

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Physiotherapy, Nutritional Supplement and Anabolic Steroids in Rehabilitation of Patients With Hip Fracture.

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