FallNCT04108793
Effectiveness of Home-based Rehabilitation Program
A study testing Physiotherapy exercises in people with Fall, run by Aga Khan University.
Trial summary
This study will be an open label, simple randomized controlled trial at a single hospital. The two arms will be equally allocated on a 1:1 ratio into intervention and control groups. Read more about this study
- Who is it for?
- Ages 60 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Fall
- What is being tested?
- Physiotherapy exercises
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 224 participants
- Where
- No sites listed yet
- Study dates
- 1 Oct 2019to 31 Oct 2021
- 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 60 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- age ≥ 60 years
- able to walk independently with or without a walking frame prior to the fracture
- diagnosis of proximal femoral fracture
- history of fall
- surgical procedure Bipolar hemiarthroplasty / total hip replacement and postoperative ambulatory status weight bearing as tolerated.
Who cannot join
- unable to walk more than one meter despite assistance with a walking aid
- legally blind
- progressive neurological disease (e.g. Parkinson's disease, dementia)
- Any medical condition precluding exercise (e.g. unstable cardiac disease) or other uncontrolled chronic conditions that would interfere with the safety and conduct of the training and testing protocol or interpretation of results.
- Patients undergoing dynamic hip screw (DHS)
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Effectiveness of Home-based Rehabilitation Program in Minimizing Disability and Secondary Falls After a Hip Fracture: A Randomized Controlled Trial
This study will be an open label, simple randomized controlled trial at a single hospital. The two arms will be equally allocated on a 1:1 ratio into intervention and control groups. The control arm will receive the usual standard postoperative rehabilitation after a bipolar hemiarthroplasty/ total hip arthroplasty which will include in hospital rehabilitation and a maximum of 5 visits postoperatively, arranged and funded by the patient as feasible. The intervention group will receive an extended home-based rehabilitation program twice a week continued for 3 months (12 weeks) after discharge funded by the study. The study will be conducted solely at Aga Khan University Hospital. The care providers involved with the study will include orthopaedic consultants, Family medicine physician, physiotherapist, and orthopaedic nurses. A total of 224 elderly patients aged 60 years and above undergoing hip fracture surgery will be evenly divided into intervention and control arms. The Primary outcome of the study is incidence of falls. Falls will be measured 3 monthly by research-assistant follow-up telephone calls for both the groups. Face to face interview which will be conducted in routine follow-up visits of all patients (both groups) will include assessment physical performance using Short Physical Performance Battery (SPPB) tool.
Read the detailed description
Hip fractures are a major health problem globally and are associated with increased morbidity, mortality, and substantial economic costs. Successful operative treatment of hip fracture patients is necessary for the optimization of post-op mobility and functional recovery of the patient. Rehabilitation after surgical stabilization of a hip fracture is crucial in order to restore pre-fracture function and to avoid long-term institutionalization. The probability of long-term confinement can be as high as 25% if the fracture is not fixed.
The combination of high incidence of fall and a high susceptibility to injury is a major public health concern among elderly population. This propensity for fall-related injury in elderly persons stems from a high prevalence of co morbid diseases such as osteoporosis and age-related physiological decline (e.g. slower reflexes) that make even a relatively mild fall, potentially dangerous The development and implementation of effective strategies to minimize disability and falls among older people is an urgent public health challenge due to the increasing proportion of older people in the global population. Besides, for many individuals, the risk of falls and disability after hospital discharge decreases with time. However, for a significant proportion, this is not the case. Many patients after discharge are readmitted with second fracture to the hospitals due to lack of acute rehabilitation programs. Therefore, we have designed a post-discharge home-based physical rehabilitation intervention program to minimize disability and falls in this high-risk elderly population.
- Conditions
- Fall
- Being tested
- Physiotherapy exercises
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Physiotherapy exercisesOther
The intervention group will receive an extended home-based rehabilitation program twice a week continued for 3 months (12 weeks) after discharge funded by the study.
| Study group | Role | What they receive |
|---|---|---|
| Intervention Arm | Experimental | The Intervention group will be given a program of progressive balance and lower limb strengthening exercises twice a week for 3 months. All exercises will include 5 minutes warm-up exercises. The lower limb extensor muscle groups (hip \& knee extensors and ankle plantar flexors) will be targeted with exercises designed to enhance postural control (i.e. balance) and muscle strength. The balance exercises include standing with a decreased base of support, forwards and sideways stepping/walking, and graded reaching activities in standing. Strengthening exercises will include sit-to-stand, forward and lateral step-ups onto a small block, semi squats and heel raises in standing. Standard principles governing frequency, volume, duration, intensity and progression of exercise will be applied. Cueing strategies will be used to reduce freezing. T Receives: Other: Physiotherapy exercises |
| Control Arm | No intervention | The control arm will receive the usual standard postoperative rehabilitation after a bipolar hemiarthroplasty/ total hip arthroplasty which will include in hospital rehabilitation and a maximum of 5 visits postoperatively |
What is being measured
The primary outcome is the main question the study is designed to answer.
occurrence of secondary fall.
The Primary outcome of the study is occurrence secondary fall. Follow-ups will be done 3 monthly by research-assistant using telephone calls for both the groups to assess if occurrence of secondary fall. A fall will be defined according to the Kellogg definition as an incident in which the body unintentionally comes to rest on the ground or other lower level which is not as a result of a violent blow, loss of consciousness, and sudden onset of paralysis as in a stroke or an epileptic seizure.
Falls will be assessed by comparing the number of falls in intervention and control groups. The occurrence of fall in each group will also be compared.
Measured: All the Patients (both groups) will be contacted after every 3 months for the period of two years via telephone call to assess occurrence of fall
Secondary outcomes (1)
Physical Mobility and Mobility-related disability
The performance-based mobility measure will be the lower extremity Summary Performance Score version of the Short Physical Performance Battery (SPPB). This battery gives a composite score based on timed performance of three mobility tasks: the ability to stand up for up to 10 seconds with feet in different positions (together side by side, semi-tandem and tandem), 4-meter walk and time to rise from a chair 5 times. The short performance based mobility tool is a valid and reliable tool with test retest validity ranging from 0.83 to 0.89
Measured: the performance-based mobility measure will be marked at every routine follow-up for up to two years using face to face interview to assess the overall trend.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Sep 2019
- Study start1 Oct 2019 (estimated)
- Primary completion31 Mar 2021 (estimated)
- Study completion31 Oct 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for FallStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 224 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Aga Khan University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. Shahryar Noordin, Aga Khan University
- Investigators
- Shahryar Noordin, MBBS,FCPS, Principal investigator, Aga Khan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04108793
- Sponsor's protocol ID
- 1533
- Status last verified
- Sep 2019
- First submitted
- 24 Sep 2019
- Last updated
- 30 Sep 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Manuscripts, conferences, symposiums
Publications
Fairhall NJ, Dyer SM, Mak JC, Diong J, Kwok WS, Sherrington C. Interventions for improving mobility after hip fracture surgery in adults. Cochrane Database Syst Rev. 2022 Sep 7;9(9):CD001704. doi: 10.1002/14651858.CD001704.pub5.
PubMed 36070134Sadruddin Pidani A, Sabzwari S, Ahmad K, Mohammed A, Noordin S. Effectiveness of home-based rehabilitation program in minimizing disability and secondary falls after a hip fracture: Protocol for a randomized controlled trial. Int J Surg Protoc. 2020 Jun 18;22:24-28. doi: 10.1016/j.isjp.2020.06.002. eCollection 2020.
PubMed 32695954
Study at a glance
From the registry record, last updated by the sponsor on 30 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Home-based Rehabilitation Program in Minimizing Disability and Secondary Falls After a Hip Fracture: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT04108793
- Acronym / sponsor ID
- 1533
- Conditions
- Fall
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 224 participants (estimated)
- Lead sponsor
- Aga Khan UniversityUniversity, hospital or other
- Study start
- 1 Oct 2019 (estimated)
- Primary completion
- 31 Mar 2021 (estimated)
- Study completion
- 31 Oct 2021 (estimated)
- First posted
- 30 Sep 2019 (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.
This study will be an open label, simple randomized controlled trial at a single hospital. The two arms will be equally allocated on a 1:1 ratio into intervention and control groups. The control arm will receive the usual standard postoperative rehabilitation after a bipolar hemiarthroplasty/ total hip arthroplasty which will include in hospital rehabilitation and a maximum of 5 visits postoperatively, arranged and funded by the patient as feasible. The intervention group will receive an extended home-based rehabilitation program twice a week continued for 3 months (12 weeks) after discharge funded by the study. The study will be conducted solely at Aga Khan University Hospital. The care providers involved with the study will include orthopaedic consultants, Family medicine physician, physiotherapist, and orthopaedic nurses. A total of 224 elderly patients aged 60 years and above undergoing hip fracture surgery will be evenly divided into intervention and control arms. The Primary outcome of the study is incidence of falls. Falls will be measured 3 monthly by research-assistant follow-up telephone calls for both the groups. Face to face interview which will be conducted in routine follow-up visits of all patients (both groups) will include assessment physical performance using Short Physical Performance Battery (SPPB) tool.
Detailed description
Hip fractures are a major health problem globally and are associated with increased morbidity, mortality, and substantial economic costs. Successful operative treatment of hip fracture patients is necessary for the optimization of post-op mobility and functional recovery of the patient. Rehabilitation after surgical stabilization of a hip fracture is crucial in order to restore pre-fracture function and to avoid long-term institutionalization. The probability of long-term confinement can be as high as 25% if the fracture is not fixed.
The combination of high incidence of fall and a high susceptibility to injury is a major public health concern among elderly population. This propensity for fall-related injury in elderly persons stems from a high prevalence of co morbid diseases such as osteoporosis and age-related physiological decline (e.g. slower reflexes) that make even a relatively mild fall, potentially dangerous The development and implementation of effective strategies to minimize disability and falls among older people is an urgent public health challenge due to the increasing proportion of older people in the global population. Besides, for many individuals, the risk of falls and disability after hospital discharge decreases with time. However, for a significant proportion, this is not the case. Many patients after discharge are readmitted with second fracture to the hospitals due to lack of acute rehabilitation programs. Therefore, we have designed a post-discharge home-based physical rehabilitation intervention program to minimize disability and falls in this high-risk elderly population.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention Arm | Experimental | Other: Physiotherapy exercisesThe Intervention group will be given a program of progressive balance and lower limb strengthening exercises twice a week for 3 months. All exercises will include 5 minutes warm-up exercises. The lower limb extensor muscle groups (hip \& knee extensors and ankle plantar flexors) will be targeted with exercises designed to enhance postural control (i.e. balance) and muscle strength. The balance exercises include standing with a decreased base of support, forwards and sideways stepping/walking, and graded reaching activities in standing. Strengthening exercises will include sit-to-stand, forward and lateral step-ups onto a small block, semi squats and heel raises in standing. Standard principles governing frequency, volume, duration, intensity and progression of exercise will be applied. Cueing strategies will be used to reduce freezing. T |
| Control Arm | No intervention | –The control arm will receive the usual standard postoperative rehabilitation after a bipolar hemiarthroplasty/ total hip arthroplasty which will include in hospital rehabilitation and a maximum of 5 visits postoperatively |
Who may qualify
- Ages
- 60 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- age ≥ 60 years
- able to walk independently with or without a walking frame prior to the fracture
- diagnosis of proximal femoral fracture
- history of fall
- surgical procedure Bipolar hemiarthroplasty / total hip replacement and postoperative ambulatory status weight bearing as tolerated.
Key exclusion criteria (5 listed)
- unable to walk more than one meter despite assistance with a walking aid
- legally blind
- progressive neurological disease (e.g. Parkinson's disease, dementia)
- Any medical condition precluding exercise (e.g. unstable cardiac disease) or other uncontrolled chronic conditions that would interfere with the safety and conduct of the training and testing protocol or interpretation of results.
- Patients undergoing dynamic hip screw (DHS)
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 |
|---|---|---|
| Physiotherapy exercisesThe intervention group will receive an extended home-based rehabilitation program twice a week continued for 3 months (12 weeks) after discharge funded by the study. | Other | Intervention Arm |
Primary outcome
occurrence of secondary fall.
Time frame: All the Patients (both groups) will be contacted after every 3 months for the period of two years via telephone call to assess occurrence of fall
The Primary outcome of the study is occurrence secondary fall. Follow-ups will be done 3 monthly by research-assistant using telephone calls for both the groups to assess if occurrence of secondary fall. A fall will be defined according to the Kellogg definition as an incident in which the body unintentionally comes to rest on the ground or other lower level which is not as a result of a violent blow, loss of consciousness, and sudden onset of paralysis as in a stroke or an epileptic seizure. Falls will be assessed by comparing the number of falls in intervention and control groups. The occurrence of fall in each group will also be compared.
1 secondary outcome
Physical Mobility and Mobility-related disability
Time frame: the performance-based mobility measure will be marked at every routine follow-up for up to two years using face to face interview to assess the overall trend.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Sep 2019.
- Derived from this study: PubMed 36070134Fairhall NJ, Dyer SM, Mak JC, Diong J, Kwok WS, Sherrington C. Interventions for improving mobility after hip fracture surgery in adults. Cochrane Database Syst Rev. 2022 Sep 7;9(9):CD001704. doi: 10.1002/14651858.CD001704.pub5.
- Derived from this study: PubMed 32695954Sadruddin Pidani A, Sabzwari S, Ahmad K, Mohammed A, Noordin S. Effectiveness of home-based rehabilitation program in minimizing disability and secondary falls after a hip fracture: Protocol for a randomized controlled trial. Int J Surg Protoc. 2020 Jun 18;22:24-28. doi: 10.1016/j.isjp.2020.06.002. eCollection 2020.
- Individual participant dataSharing planned: Yes. Manuscripts, conferences, symposiums
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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.
Shahryar Noordin, MBBS,FCPS principal investigator
Aga Khan University
Questions about this trial
What is this clinical trial studying?
A study testing Physiotherapy exercises in people with Fall, run by Aga Khan University.
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 5 inclusion and 5 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 30 Sep 2019. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Shahryar Noordin, MBBS,FCPS (+92 34864384 ext. 4384, shahryar.noordin@aku.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
occurrence of secondary fall. (time frame: All the Patients (both groups) will be contacted after every 3 months for the period of two years via telephone call to assess occurrence of fall). 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 NCT04108793, which also lists 2 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 30 Sep 2019.