Accidental FallsPhase 3NCT00133640
Early Rehabilitation After Hip Fracture
A Phase 3 study testing cholecalciferol and Physiotherapy in people with Accidental Falls and Fractures, run by Swiss National Science Foundation at 1 site in Switzerland.
Trial summary
The aim of this study is to compare a low versus high intensity physiotherapy early rehabilitation program combined with a low versus high dose vitamin D early rehabilitation program in a randomized controlled trial among elderly patients with acute hip fracture in an acute care setting. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Accidental Falls, Fractures, Hip Fractures
- What is being tested?
- cholecalciferol and Physiotherapy
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 204 participants
- Where
- 1 siteSwitzerland
- Study dates
- Jan 2005to Dec 2008
- Phase
- Phase 3
- 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 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- Age 65 years or older
- Acute hip fracture admitted to one hospital center
Who cannot join
- A Folstein Mini Mental Score of less than 15 as an indicator of significant dementia
- Primary hyperparathyroidism
- Current cancer with wasting or bone metastases
- Hyperparathyroidism
- Sarcoidosis
- A kidney stone in the past 5 years or significant renal disease (creatinine clearance below 15 ml/min)
Show all 10Show fewer
- Hypercalcemia (albumin adjusted) of more than 2.8 mmol/l
- non-surgical treatment
- no German language skills
- severe hearing or visual impairment
Trial locations and contacts
1 site in 1 country.
Switzerland1 site, 1 recruiting
- Recruiting
Triemli Hospital
Zurich, 8063
Heike A Bischoff-Ferrari, MD, MPH, +41-44-2552699, HeikeBischoff@usz.ch
Robert Theiler, MD
About this study
Official title: Early Rehabilitation After Hip Fracture: A Randomized Controlled Trial Comparing Different Vitamin D and Rehabilitation Programs
The aim of this study is to compare a low versus high intensity physiotherapy early rehabilitation program combined with a low versus high dose vitamin D early rehabilitation program in a randomized controlled trial among elderly patients with acute hip fracture in an acute care setting. The primary outcome to be compared between treatment arms is the rate of falls during a 12-month follow-up. Secondary outcomes are injurious falls, number of persons who fell, low-trauma fractures (at the hip, forearm, humerus, pelvis, ankle, spine, femur, tibia), disability, quality of life (Euro-Qol), mortality and health care utilization. Another secondary outcome will be admission to nursing home compared between treatment arms among subjects, who are community-dwelling prior to the index hip fracture. Admission to nursing home is the marker of loss of independence for the individual, but also triggers high cost for the society.
The study will provide new early rehabilitation guidelines to allocate health care resources efficiently in the acute care setting. Eventually and most importantly, the study will help improve outcomes in patients with hip fractures.
Read the detailed description
Subjects:
The researchers will enroll 204 elderly subjects (men and women) admitted to two large hospital centers with acute hip fracture. Subjects may be institutionalized or community-dwelling prior to admission. To be enrolled in the study subjects need to be 65 years or older. Demented persons, who reach a Folstein Mini Mental Status of less than 15 are excluded.
Design:
Once written informed consent from participants or proxies is given, subjects will be randomly assigned to 4 different program combinations based on a 2X2 factorial design: (1) low dose vitamin D / low intensity physiotherapy; or (2) low dose vitamin D / high intensity physiotherapy; or (3) high dose vitamin D / low intensity physiotherapy; or (4) high dose vitamin D / high intensity physiotherapy. Low dose Vitamin D is 800 IU cholecalciferol per day and high dose vitamin D is 2000 IU cholecalciferol per day.
Subjects will be recruited within 5 days after hip fracture surgery and followed for adverse outcomes over a 12-month period. Dose of vitamin D will be double-blinded.
- Conditions
- Accidental Falls, Fractures, Hip Fractures
- Being tested
- cholecalciferol, Physiotherapy
- Keywords
- Vitamin D, Elderly, Hip fracture, Falls, Physical Therapy, Disability
- Medical subject headings
- Fractures, Bone, Hip Fractures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
cholecalciferolDrug
PhysiotherapyBehavioural
What is being measured
The primary outcome is the main question the study is designed to answer.
rate of falls compared between treatment arms
Secondary outcomes (8)
rate of injurious falls
number of persons who fell
low-trauma fractures (at the hip, forearm, humerus, pelvis, ankle, spine, femur, tibia)
disability
quality of life (Euro-Qol)
mortality
health care utilization
admission to nursing home compared between treatment arms among subjects, who are community-dwelling prior to the index hip fracture
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Aug 2005 (estimated)
- Study startJan 2005
- Study completionDec 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Accidental FallsStudies 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 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Double blind
- Enrolment
- 204 participants
Sponsor and investigators
- Lead sponsor
- Swiss National Science Foundation
- Sponsor type
- University, hospital or other
- Investigators
- Heike A Bischoff-Ferrari, MD, MPH, Principal investigator, University of ZurichRobert Theiler, MD, Study director, Triemli Spital ZurichHannes B Staehelin, MD, Study chair, University of BaselAndreas Platz, MD, Study director, TriemliSpital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00133640
- Sponsor's protocol ID
- 405340-104845
- Other IDs
- NFP 53-405340-104845
- Status last verified
- Aug 2006
- First submitted
- 22 Aug 2005
- Last updated
- 11 Sep 2006
- Results posted
- No
Publications
Braendle K, Egli A, Bischoff-Ferrari H, Freystaetter G. Does living alone influence fall risk among Swiss older adults aged 60+? A pooled observational analysis of three RCTs on fall prevention. BMJ Open. 2024 May 20;14(5):e081413. doi: 10.1136/bmjopen-2023-081413.
PubMed 38772577Fischer K, Trombik M, Freystatter G, Egli A, Theiler R, Bischoff-Ferrari HA. Timeline of functional recovery after hip fracture in seniors aged 65 and older: a prospective observational analysis. Osteoporos Int. 2019 Jul;30(7):1371-1381. doi: 10.1007/s00198-019-04944-5. Epub 2019 Apr 2.
PubMed 30941485Nardi M, Fischer K, Dawson-Hughes B, Orav EJ, Meyer OW, Meyer U, Beck S, Simmen HP, Pape HC, Egli A, Willett WC, Theiler R, Bischoff-Ferrari HA. Association between Caregiver Role and Short- and Long-Term Functional Recovery after Hip Fracture: A Prospective Study. J Am Med Dir Assoc. 2018 Feb;19(2):122-129. doi: 10.1016/j.jamda.2017.08.009. Epub 2017 Sep 30.
PubMed 28974464Schaller F, Sidelnikov E, Theiler R, Egli A, Staehelin HB, Dick W, Dawson-Hughes B, Grob D, Platz A, Can U, Bischoff-Ferrari HA. Mild to moderate cognitive impairment is a major risk factor for mortality and nursing home admission in the first year after hip fracture. Bone. 2012 Sep;51(3):347-52. doi: 10.1016/j.bone.2012.06.004. Epub 2012 Jun 12.
PubMed 22705148Bischoff-Ferrari HA, Dawson-Hughes B, Platz A, Orav EJ, Stahelin HB, Willett WC, Can U, Egli A, Mueller NJ, Looser S, Bretscher B, Minder E, Vergopoulos A, Theiler R. Effect of high-dosage cholecalciferol and extended physiotherapy on complications after hip fracture: a randomized controlled trial. Arch Intern Med. 2010 May 10;170(9):813-20. doi: 10.1001/archinternmed.2010.67.
PubMed 20458090
Study at a glance
From the registry record, last updated by the sponsor on 11 Sep 2006. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Early Rehabilitation After Hip Fracture: A Randomized Controlled Trial Comparing Different Vitamin D and Rehabilitation Programs
- ClinicalTrials.gov ID
- NCT00133640
- Acronym / sponsor ID
- 405340-104845
- Conditions
- Accidental Falls, Fractures, Hip Fractures
- Keywords
- Vitamin D, Elderly, Hip fracture, Falls, Physical Therapy, Disability
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 204 participants
- Lead sponsor
- Swiss National Science FoundationUniversity, hospital or other
- Study start
- Jan 2005
- Study completion
- Dec 2008
- First posted
- 23 Aug 2005 (estimated)
- 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.
The aim of this study is to compare a low versus high intensity physiotherapy early rehabilitation program combined with a low versus high dose vitamin D early rehabilitation program in a randomized controlled trial among elderly patients with acute hip fracture in an acute care setting. The primary outcome to be compared between treatment arms is the rate of falls during a 12-month follow-up. Secondary outcomes are injurious falls, number of persons who fell, low-trauma fractures (at the hip, forearm, humerus, pelvis, ankle, spine, femur, tibia), disability, quality of life (Euro-Qol), mortality and health care utilization. Another secondary outcome will be admission to nursing home compared between treatment arms among subjects, who are community-dwelling prior to the index hip fracture. Admission to nursing home is the marker of loss of independence for the individual, but also triggers high cost for the society.
The study will provide new early rehabilitation guidelines to allocate health care resources efficiently in the acute care setting. Eventually and most importantly, the study will help improve outcomes in patients with hip fractures.
Detailed description
Subjects:
The researchers will enroll 204 elderly subjects (men and women) admitted to two large hospital centers with acute hip fracture. Subjects may be institutionalized or community-dwelling prior to admission. To be enrolled in the study subjects need to be 65 years or older. Demented persons, who reach a Folstein Mini Mental Status of less than 15 are excluded.
Design:
Once written informed consent from participants or proxies is given, subjects will be randomly assigned to 4 different program combinations based on a 2X2 factorial design: (1) low dose vitamin D / low intensity physiotherapy; or (2) low dose vitamin D / high intensity physiotherapy; or (3) high dose vitamin D / low intensity physiotherapy; or (4) high dose vitamin D / high intensity physiotherapy. Low dose Vitamin D is 800 IU cholecalciferol per day and high dose vitamin D is 2000 IU cholecalciferol per day.
Subjects will be recruited within 5 days after hip fracture surgery and followed for adverse outcomes over a 12-month period. Dose of vitamin D will be double-blinded.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Double blind
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (2 listed)
- Age 65 years or older
- Acute hip fracture admitted to one hospital center
Key exclusion criteria (10 listed)
- A Folstein Mini Mental Score of less than 15 as an indicator of significant dementia
- Primary hyperparathyroidism
- Current cancer with wasting or bone metastases
- Hyperparathyroidism
- Sarcoidosis
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 |
|---|---|---|
| cholecalciferol | Drug | – |
| Physiotherapy | Behavioural | – |
Primary outcome
rate of falls compared between treatment arms
8 secondary outcomes
rate of injurious falls
number of persons who fell
low-trauma fractures (at the hip, forearm, humerus, pelvis, ankle, spine, femur, tibia)
disability
quality of life (Euro-Qol)
mortality
health care utilization
admission to nursing home compared between treatment arms among subjects, who are community-dwelling prior to the index hip fracture
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Sep 2006.
- Derived from this study: PubMed 38772577Braendle K, Egli A, Bischoff-Ferrari H, Freystaetter G. Does living alone influence fall risk among Swiss older adults aged 60+? A pooled observational analysis of three RCTs on fall prevention. BMJ Open. 2024 May 20;14(5):e081413. doi: 10.1136/bmjopen-2023-081413.
- Derived from this study: PubMed 30941485Fischer K, Trombik M, Freystatter G, Egli A, Theiler R, Bischoff-Ferrari HA. Timeline of functional recovery after hip fracture in seniors aged 65 and older: a prospective observational analysis. Osteoporos Int. 2019 Jul;30(7):1371-1381. doi: 10.1007/s00198-019-04944-5. Epub 2019 Apr 2.
- Derived from this study: PubMed 28974464Nardi M, Fischer K, Dawson-Hughes B, Orav EJ, Meyer OW, Meyer U, Beck S, Simmen HP, Pape HC, Egli A, Willett WC, Theiler R, Bischoff-Ferrari HA. Association between Caregiver Role and Short- and Long-Term Functional Recovery after Hip Fracture: A Prospective Study. J Am Med Dir Assoc. 2018 Feb;19(2):122-129. doi: 10.1016/j.jamda.2017.08.009. Epub 2017 Sep 30.
- Derived from this study: PubMed 22705148Schaller F, Sidelnikov E, Theiler R, Egli A, Staehelin HB, Dick W, Dawson-Hughes B, Grob D, Platz A, Can U, Bischoff-Ferrari HA. Mild to moderate cognitive impairment is a major risk factor for mortality and nursing home admission in the first year after hip fracture. Bone. 2012 Sep;51(3):347-52. doi: 10.1016/j.bone.2012.06.004. Epub 2012 Jun 12.
- Derived from this study: PubMed 20458090Bischoff-Ferrari HA, Dawson-Hughes B, Platz A, Orav EJ, Stahelin HB, Willett WC, Can U, Egli A, Mueller NJ, Looser S, Bretscher B, Minder E, Vergopoulos A, Theiler R. Effect of high-dosage cholecalciferol and extended physiotherapy on complications after hip fracture: a randomized controlled trial. Arch Intern Med. 2010 May 10;170(9):813-20. doi: 10.1001/archinternmed.2010.67.
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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.
Heike A Bischoff-Ferrari, MD, MPH principal investigator
University of Zurich
Robert Theiler, MD study director
Triemli Spital Zurich
Hannes B Staehelin, MD study chair
University of Basel
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing cholecalciferol and Physiotherapy in people with Accidental Falls and Fractures, run by Swiss National Science Foundation at 1 site in Switzerland.
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 2 inclusion and 10 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: status not confirmed, as of the sponsor's last update on 11 Sep 2006. 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 Switzerland. 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Heike A Bischoff-Ferrari, MD, MPH (+41-44-2552699, Heike.Bischoff@usz.ch), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
rate of falls compared between treatment arms. 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 NCT00133640, which also lists 5 linked publications.
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 11 Sep 2006.