Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12605000164695
Ethics application status
Approved
Date submitted
11/08/2005
Date registered
16/08/2005
Date last updated
16/09/2010
Type of registration
Retrospectively registered

Titles & IDs
Public title
Hip Fracture Intervention Trial
Scientific title
Hip Fracture Intervention Trial (HIPFIT): A randomized
controlled trial of a targeted multifactorial intervention to improve long
term disability after hip fracture
Secondary ID [1] 252212 0
Hip Fracture Intervention Trial
Universal Trial Number (UTN)
Trial acronym
HIPFIT
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Fracture neck of femur 259 0
Condition category
Condition code
Injuries and Accidents 291 291 0 0
Fractures

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Intervention group receives one or more of the following treatments, depending on their condition, the outcome of the assessments and the recommendations from the geriatricians and the multidiciplinary team:
1. Progressive resistance training (all participants)
; 2 x 1 hour session per week for 12 months in small groups of maximum 4 participants supervised by exercise physiologist. High intensity progressive resistance training on pneumatic resistance machines.
Volume: 3 sets of 8 repetitions on 7 machines: leg press, standing hip extension and abduction, knee extension, knee flexion, triceps, chest press, seated row
Intensity: 80% of most recent one repetition maximum (1RM) or rating less than 15 on Borg's scale of perceived exertion.

2. Balance training:
Progressing through eight different exercises, each with progressive levels of difficulty, until mastered: Sitting balance, Single Leg Stand, Med-Lat Shift, Ant-Post Shift, Stepping over Objects, Tandem Walk, Toe Walk, Heel Walk. Wobble board practice. 2 x 15 minutes session per week for 12 months in small groups of maximum 4 participants supervised by exercise physiologist.

3. Home assessment and modification (all participants): Administered by research assistant in consultation with interdisciplinary team. A comprensive assessment of the residence & its access was conducted by research staff looking for any hazard, falls risk & obstacles to independence to address. After discussion with the interdisciplinary team an individualized plan was drawn & implemented by research staff. This was followed up by the research staff at monthly visits.
4. Nutritional supplementation and support for nutrition-related Instrumental Activities of Daily Living (IADLs):
Administered face to face by research staff and/or dietician
Provision of nutritional supplement and/or dietary advice to increase energy (400-600 kcal) / protein (20 gm) intake, Nutritional supplements used: Resource and 2cal.
Dietary advice: encouraged to consume increased Protein and calorie rich foods and snacks throughout day, preferred sources: Meat, Fish, Meat and cheese pizza, Meat Pies, Whole Milk, Whole Mild Yogurt, Hard Cheese, Whole Mild Custard, Whole Milk Ice Cream, Milkshakes, smoothies, Liquid supplements (2 cal if possible), High protein bars, Muffins, Dried fruit, Nuts, Peanut butter, Nutella sandwiches, Butter, margarine, mayonnaise on all breads, Add sugar, honey, syrup, cream to cereals and porridge, Cook with olive or canola oil, Add evaporated milk, cream, cheese or dry milk powder to soups, casseroles, Omlettes with cheese, ham. Chocolate candy, hot cocoa, Milo made with whole milk
Cheese and crackers, cheese and peanut butter snacks
Supplements:1 to 3 times a day in between meals, as well as after exercise training sessions for both supplements & increase in calories. Reviewed monthly.

5. Calcium and Vitamin D deficiency:
Vitamin D supplementation when 25-OH Vitamin D level <40 ng/ml: 12 months of Vit D orally (Osteolyn 1000 IU/day)
Calcium supplementation when Calcium intake <1200 mg/day in diet: Caltrate 600 mg 2 x day for 12 months.

6. Depression treatment:
- Resistance training 2 days a week, Frequency-3 sets of 8 reps on 7 machines Intensity-80% of most recent one repetition maximum (1 RM) or rating less than 15 on Borg's perceived exertion scale.
- Pleasurable events scheduled as appropriate
- Problem solving as needed
- Optimise medical condition by geriatrician and reviewed monthly
- Antidepressant: Cipramil if determined by geriatrician review and repeat gds scale at one month that prt and cbt were not sufficient

7. Visual impairment support/referral:
- Cataract extraction referral at time of initial assessment by ophtalmologist
- New prescription for read/distance glasses at time of initial assessment by ophtalmologist
- Elimination of bifocals as part of new glasses prescription
- New glaucoma medications
- Home modifications at initial visit & followed up monthly by research staff
- Referral to Blind Society services/resources
- Provision of support for ADL’s unable to be done due to visual impairment as needed

8. Treatment for dementia and familiy education:
- Optimise medical condition
- Minimise drugs by geriatrician in collaboration with general practitioner
- Commence donepezil if determined needed by geriatrician review
- Family/caregiver support and counseling;
- Referral to Alzheimers Association

9. Hip protectors (all participants):
Hip protectors are shields worn over the hip bone to assist in preventing hip fracture in the event of a fall. The soft silicone shields that absorb the force of an impact caused by a fall onto the hip are held in place by specially designed underwear.
When to wear: Put on in the morning when dressing and take off at night when going to bed.
How to wear:
1)place the shields in the inside pockets of the pants:
-hollow side faces in, towards the hip
-rounded side faces out, away from the hip
2) put on as normal underpants so that the pants are well adjusted with the shields at hip height

10. Social support network optimisation:
Individual packages varying according to the individual’s needs, for the 12 months of the study participation & reviewed at monthly visits. One or more of the following involved:
- Practical care such as services to help with self care, meals, medications, cleaning & shopping
- Social and emotional support through regular planned visits and phone calls
- Information and advice relevant to the rehabilitation process and/or availability of appropriate programs or services
- Monthly visit by research staff

11 Self-efficacy education/training:
Self-efficacy as needed one or more of the following administered face to face by research staff and reviewed at monthly visits and administered by group education sessions
- Use of confidence stepladder
- Exploring barriers and overcoming obstacles
- Breaking down skills, practice, reframing negative statements

12. Management of polypharmacy:
management of polypharmacy
- Medication review by geriatrician
- Consultation with General Practitioner
- Education of patient/caregiver
- Completion of medical record card from pharmacy

13. Pharmacological treatment of osteoporosis (all participants:
- 12 months of Vit D orally (Osteolyn 1000 IU/day) or calcium and Vit D (Caltrate 600 mg 2 x day plus Osteolyn)
- 12 months Biophosphonates Fosamax
- Provision of educational materials

The overall period duration of this intervention 12 months with yearly follow-up for 4 years (at 2, 3, 4 and 5 years post hip fracture). The intervention group is being monitored closely throughout the 12 months. For both groups, the assessments are done at 3 timepoints: baseline, 4 months and 12 months. Update description of intervention(s) / exposure:
Participants are also called yearly for the next 4 years following the 12 month assessment to ascertain functional and residency status.
Intervention code [1] 176 0
Treatment: Other
Comparator / control treatment
Control group is assessed at baseline, 4 and 12 months and a letter sent to their general practitioner (GP) at each time point identifying any abnormalities in vision, vitamin D, depression, or cognition. No recommendations for specific treatment made.
Control group
Active

Outcomes
Primary outcome [1] 339 0
1. Disability: Place of residence (nursing home or community), Blinded assessment of Functional Independence Measure (FIM) and Assessment of Living Skills and Resources (ALSAR); unblinded assessment of Katz Activities of Daily Living (ADL) scale, The National Health and Nutrition Examination Survey (NHANES) Functional Status Survey for ADL, Instrumental Activities of Daily Living (IADL) dependency and assistive device utilization and availability
Timepoint [1] 339 0
The assessments are done at baseline, 4 months and 12 months
Primary outcome [2] 340 0
Functional impairrement assessed with FIM & ALSAR questionnaires
Timepoint [2] 340 0
The assessments are done at baseline, 4 months and 12 months
Primary outcome [3] 341 0
Nutritional StatusAssessed by:
- Mini Nutritional Assessment questionnaire
- Body Mass Index (BMI) <22 kg/m2
- Unintentional weight loss of 5% or more of total weight over last 6 months
Timepoint [3] 341 0
The assessments are done at baseline, 4 months and 12 months
Primary outcome [4] 342 0
Health Status, including mortality, assessed from medical records, questionnaires, participants & family interview.
Timepoint [4] 342 0
The assessments are done at baseline, 4 months and 12 months
Secondary outcome [1] 775 0
1. Muscle strength
Timepoint [1] 775 0
For both groups, the assessments are done at 3 timepoints; baseline, 4 months and 12 months.
Secondary outcome [2] 776 0
2. Gait and balance
Timepoint [2] 776 0
For both groups, the assessments are done at 3 timepoints; baseline, 4 months and 12 months.
Secondary outcome [3] 777 0
3. Depression
Timepoint [3] 777 0
For both groups, the assessments are done at 3 timepoints; baseline, 4 months and 12 months.
Secondary outcome [4] 778 0
4. Self-efficacy.
Timepoint [4] 778 0
For both groups, the assessments are done at 3 timepoints; baseline, 4 months and 12 months.

Eligibility
Key inclusion criteria
1. Patients admitted to Royal Prince Alfred Hospital, Balmain Hospital, Concord Hospital and Metropolitain Rehabilitation Hospital for surgical repair of fractured neck of femur 2. Not severely cognitively impaired 3. No terminal or rapidly progressive illness preventing participation in study protocols 4. Planning to reside in Central Sydney area for 12 months 5. Adequate English comprehension.
Minimum age
55 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Age under 55
Demented
Terminally ill
Unwilling or unable to participate in study protocols

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Concealed allcation is being carried out by a personnel who has no contact with recruited subjects
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Computerised random allocation
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Active, not recruiting
Date of first participant enrolment
Anticipated
1/02/2002
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
284
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment postcode(s) [1] 198 0
2141

Funding & Sponsors
Funding source category [1] 350 0
Government body
Name [1] 350 0
NHMRC
Country [1] 350 0
Australia
Primary sponsor type
Government body
Name
NHMRC
Address
Level 5, 20 Allara Street
Civic ACT 2601
Country
Australia
Secondary sponsor category [1] 275 0
University
Name [1] 275 0
The University of Sydney
Address [1] 275 0
75 East Street
Lidcombe NSW 2141
Country [1] 275 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 1315 0
Central Sydney Area Health Services
Ethics committee address [1] 1315 0
Ethics committee country [1] 1315 0
Australia
Date submitted for ethics approval [1] 1315 0
Approval date [1] 1315 0
Ethics approval number [1] 1315 0
Ethics committee name [2] 1316 0
The University of Sydney
Ethics committee address [2] 1316 0
Ethics committee country [2] 1316 0
Australia
Date submitted for ethics approval [2] 1316 0
Approval date [2] 1316 0
Ethics approval number [2] 1316 0

Summary
Brief summary
Many patients with hip fracture end up disabled or in nursing homes in the year following fracture. Current treatment protocols do not systematically address risk factors for disability. We will recruit 600 patients who have fractured their hip. Subjects will be randomized to receive usual care or the HIPFIT intervention, which includes targeted treatments for depression, muscle weakness, poor gait and balance, malnutrition, vitamin D deficiency, poor vision, environmental hazards in the home, social isolation, and low self-efficacy, as needed. The two groups will be followed for 12 months to determine differences in disability and need for residential care.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 35507 0
Address 35507 0
Country 35507 0
Phone 35507 0
Fax 35507 0
Email 35507 0
Contact person for public queries
Name 9365 0
Professor Maria Fiatarone Singh
Address 9365 0
School of Exercise and Sport Science
The University of Sydney
East Street
Lidcombe NSW 2141
Country 9365 0
Australia
Phone 9365 0
+61 2 93519755
Fax 9365 0
+61 2 93519204
Email 9365 0
maria.fiataronesingh@sydney.edu.au
Contact person for scientific queries
Name 293 0
Professor Maria Fiatarone Singh
Address 293 0
School of Exercise and Sport Science
The University of Sydney
East Street
Lidcombe NSW 2141
Country 293 0
Australia
Phone 293 0
+61 2 93519755
Fax 293 0
+61 2 93519204
Email 293 0
maria.fiataronesingh@sydney.edu.au

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No Supporting Document Provided



Results publications and other study-related documents

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