Hip FracturesIPPAHSNCT04804527
Intensified In-hospital Physiotherapy for Patients After Hip Fracture Surgery.
A study testing Intensified physiotherapy in people with Hip Fractures, run by Bispebjerg Hospital at 1 site in Denmark.
Trial summary
Regaining basis mobility after a hip fracture surgery is an important in-hospital rehabilitation goal because patients who have regained basis mobility at pre-fracture level at discharge have lower 30-day mortality and readmission rate and are more likely to be discharged to their own home. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Hip Fractures
- What is being tested?
- Intensified physiotherapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteDenmark
- Study dates
- 9 Apr 2021to 10 Jan 2022
- 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 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- A patient will be eligible for study participation if he/she meets the following criteria:
- Diagnosed with an isolated, first time hip fracture on the affected side
- Age ≥ 65 years
- Able to speak and understand Danish
- Home-dwelling with an independent pre-fracture ability to walk indoors (New Mobility Score (NMS) ≥ 2)
- Able to give written informed consent prior to physiotherapy in the first postoperative day
Who cannot join
- A participant will be excluded from the study if he/she meets any of the following criteria:
- The fracture is pathological (e.g. cancer-based)
- Postoperative weight-bearing is restricted
- Multiple body fractures are present
- Serious postoperative medical complications occur
- Any other conditions that in the opinion of the investigator makes a potential participant unfit for participation
Trial locations and contacts
1 site in 1 country.
Denmark1 site
Bispebjerg Hospital, Department of Physical & Occupational Therapy
Copenhagen, 2400
About this study
Official title: Intensified In-hospital Physiotherapy for Patients After Hip Fracture Surgery (IPPAHS). A Pragmatic, Randomized Feasibility Trial.
Regaining basis mobility after a hip fracture surgery is an important in-hospital rehabilitation goal because patients who have regained basis mobility at pre-fracture level at discharge have lower 30-day mortality and readmission rate and are more likely to be discharged to their own home. However, at discharge only half of the patients have regained their pre-fracture basis mobility level.
Intensified acute in-hospital physiotherapy (e.g. more than once daily) highlighting weight-bearing activities and ambulation could have a positive effect on the proportion of patients who regain their pre-facture basic mobility at discharge. However, data from daily clinical practice suggest that only half of the patients are able to complete physiotherapy on the first postoperative day and that fatigue, hip fracture-related pain and habitual cognitive status are the most frequent reasons for not completing planned physiotherapy (once daily) during the first three postoperative days. Thus to undertake an RCT investigating the effect of intensified acute in-hospital physiotherapy i.e. two daily sessions of physiotherapy compared to usual care i.e. one daily session, on regained pre-facture basic mobility at discharge in patients with hip fracture raises important practical concerns regarding e.g. completion rate of planned physiotherapy. The potential positive effects of intensified physiotherapy will be hampered if too many patients are unable to complete planned physiotherapy e.g. because of fatigue or pain. Feasibility studies ask whether something can be done and are preliminary studies conducted specifically for the purposes of establishing whether or not a full trial will be feasible to conduct. Thus, the main aim of the trial is to assess the feasibility of conducting a definitive pragmatic RCT in terms of implementation, practicality and acceptability of intensified acute in-hospital physiotherapy i.e. two daily sessions of physiotherapy highlighting weight-bearing activities and ambulation on weekdays among patients with hip fracture.
The main predefined feasibility criterium is that about twice as many physiotherapy sessions are completed in the intensified physiotherapy group compared to in the usual care physiotherapy group.
- Conditions
- Hip Fractures
- Being tested
- Intensified physiotherapy, Usual care physiotherapy
- Keywords
- Exercise Therapy, Physical Therapy Modalities, Mobility Limitation, Feasibility Studies
- Medical subject headings
- Hip Fractures, Mobility Limitation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intensified physiotherapyOther
Physiotherapy x2
Usual care physiotherapyOther
Physiotherapy x1
| Study group | Role | What they receive |
|---|---|---|
| Intensified physiotherapy | Experimental | In addition to usual care physiotherapy patients in the intensified physiotherapy group will receive an extra physiotherapy session of up to 30 minutes on every weekday starting on the first postoperative day. The session will include progressive functional training of basic mobility and walking in the ward delivered by an experienced physiotherapist affiliated with the trial. The aim of this additional session is to improve the functional advances achieved during the earlier physiotherapy session. Receives: Other: Intensified physiotherapy |
| Usual care physiotherapy | Active comparator | Patients will receive approximately 30 minutes physiotherapy once daily in the ward delivered by the ward's usual physiotherapists i.e. starting on the first postoperative day and thereafter primarily on weekdays until discharge (a mean of 8.82 days after admission). Usual care physiotherapy is individualized taking the patients ability and previous level of functioning into account and includes 1) progressive functional training of basic mobility e.g. in-out of bed, sit-to-stand and walking including progression in walking aid, stair training if possible, and advices toward better physical functional level, 2) basic bed exercises with progression to standing exercises according to a hand-out training program and recommendations on doing exercises daily and being as physical active as possible during the day. Receives: Other: Usual care physiotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total physiotherapy completion rate during hospitalization
The degree of completion (successful completion, partial completion or cancellation) of every physiotherapy session on weekdays from the first postoperative day to discharge will be rated by the physiotherapists and total physiotherapy completion rate during hospitalization will be calculated. The physiotherapists will also register cause of partial completion or cancellation.
Measured: Through hospital stay, an average of 8.82 days after admission.
Secondary outcomes (8)
Hip-fracture-related pain at rest
Measured at rest before physiotherapy using a five-point (no, slight, moderate, severe, unbearable pain) Verbal Rating Scale (VRS) on weekdays from the first postoperative day to discharge.
Measured: Through hospital stay, an average of 8.82 days after admission.
Hip-fracture-related pain during physiotherapy
Measured during physiotherapy using a five-point (no, slight, moderate, severe, unbearable pain) Verbal Rating Scale (VRS) on weekdays from the first postoperative day to discharge.
Measured: Through hospital stay, an average of 8.82 days after admission.
Fatigue at rest
Measured at rest before physiotherapy using a five-point (no, slight, moderate, severe, unbearable fatigue) Verbal Rating Scale (VRS) on weekdays from the first postoperative day to discharge.
Measured: Through hospital stay, an average of 8.82 days after admission.
Fatigue during physiotherapy
Measured during physiotherapy using a five-point (no, slight, moderate, severe, unbearable fatigue) Verbal Rating Scale (VRS) on weekdays from the first postoperative day to discharge.
Measured: Through hospital stay, an average of 8.82 days after admission.
Upright time during hospitalization
Time spend standing or walking assessed by using a body-worn accelerometer-based activity monitor (ActivePAL3c). The monitor will be attached to the thigh of the non-operated leg on the first postoperative day and the patient will wear the monitor continuously during hospitalization.
Measured: From the second postoperative day to discharge, though for a maximum of 10 days after surgery.
Upright events during hospitalization
Transitions from sitting to standing assessed by using a body-worn accelerometer-based activity monitor (ActivePAL3c). The monitor will be attached to the thigh of the non-operated leg on the first postoperative day and the patient will wear the monitor continuously during hospitalization.
Measured: From the second postoperative day to discharge, though for a maximum of 10 days after surgery.
Basic mobility assessed using The Cumulated Ambulation Score (CAS)
Basic mobility measured by using the Cumulated Ambulation Score (CAS) will be assessed in conjunction with every physiotherapy session on weekdays from the first postoperative day to discharge. The CAS is a tester administered score which describes the patient's independency in (1) getting in and out of bed, (2) sit to stand from a chair, and (3) walking ability (with and without walking aid). Each activity is assessed on a three-point ordinal scale from 0 to 2 (0: Not able to with human assistance and verbal cueing, 1: able to with human assistance or verbal cueing 2: Able to safely without human assistance or verbal cueing) resulting in a total CAS score between 0 and 6 (6 indicating independent ambulation).
Measured: Through hospital stay, an average of 8.82 days after admission.
Regain of pre-fracture basic mobility level at discharge
Basic mobility measured by using the Cumulated Ambulation Score (CAS). The CAS is a tester administered score which describes the patient's independency in (1) getting in and out of bed, (2) sit to stand from a chair, and (3) walking ability (with and without walking aid). Each activity is assessed on a three-point ordinal scale from 0 to 2 (0: Not able to with human assistance and verbal cueing, 1: able to with human assistance or verbal cueing 2: Able to safely without human assistance or verbal cueing) resulting in a total CAS score between 0 and 6 (6 indicating independent ambulation).
Measured: Baseline (pre-fracture) and at discharge an average of 8.82 days after admission
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Mar 2021
- Study start9 Apr 2021
- Primary completion10 Jan 2022
- Study completion10 Jan 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hip FracturesStudies 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This is a pragmatic, randomized, controlled, unblinded feasibility trial with two parallel groups: an intervention group receiving intensified acute in-hospital physiotherapy (n=40) and a control group receiving usual care acute in-hospital physiotherapy (n=20).
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bispebjerg Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Gigtforeningen, Danske Fysioterapeuter
- Responsible party
- Principal investigator, Theresa Bieler, Bispebjerg Hospital
- Investigators
- Theresa Bieler, PhD, Study director, Bispebjerg and Frederiksberg Hospital, Dept. of Physical & Occupational Therapy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04804527
- Sponsor's protocol ID
- P-2020-828
- Acronym
- IPPAHS
- Status last verified
- Jan 2022
- First submitted
- 4 Mar 2021
- Last updated
- 12 Jan 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intensified In-hospital Physiotherapy for Patients After Hip Fracture Surgery (IPPAHS). A Pragmatic, Randomized Feasibility Trial.
- ClinicalTrials.gov ID
- NCT04804527
- Acronym / sponsor ID
- IPPAHS / P-2020-828
- Conditions
- Hip Fractures
- Keywords
- Exercise Therapy, Physical Therapy Modalities, Mobility Limitation, Feasibility Studies
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Bispebjerg HospitalUniversity, hospital or other
- Collaborators
- Gigtforeningen, Danske Fysioterapeuter
- Study start
- 9 Apr 2021 (actual)
- Primary completion
- 10 Jan 2022 (actual)
- Study completion
- 10 Jan 2022 (actual)
- First posted
- 18 Mar 2021 (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.
Regaining basis mobility after a hip fracture surgery is an important in-hospital rehabilitation goal because patients who have regained basis mobility at pre-fracture level at discharge have lower 30-day mortality and readmission rate and are more likely to be discharged to their own home. However, at discharge only half of the patients have regained their pre-fracture basis mobility level.
Intensified acute in-hospital physiotherapy (e.g. more than once daily) highlighting weight-bearing activities and ambulation could have a positive effect on the proportion of patients who regain their pre-facture basic mobility at discharge. However, data from daily clinical practice suggest that only half of the patients are able to complete physiotherapy on the first postoperative day and that fatigue, hip fracture-related pain and habitual cognitive status are the most frequent reasons for not completing planned physiotherapy (once daily) during the first three postoperative days. Thus to undertake an RCT investigating the effect of intensified acute in-hospital physiotherapy i.e. two daily sessions of physiotherapy compared to usual care i.e. one daily session, on regained pre-facture basic mobility at discharge in patients with hip fracture raises important practical concerns regarding e.g. completion rate of planned physiotherapy. The potential positive effects of intensified physiotherapy will be hampered if too many patients are unable to complete planned physiotherapy e.g. because of fatigue or pain. Feasibility studies ask whether something can be done and are preliminary studies conducted specifically for the purposes of establishing whether or not a full trial will be feasible to conduct. Thus, the main aim of the trial is to assess the feasibility of conducting a definitive pragmatic RCT in terms of implementation, practicality and acceptability of intensified acute in-hospital physiotherapy i.e. two daily sessions of physiotherapy highlighting weight-bearing activities and ambulation on weekdays among patients with hip fracture.
The main predefined feasibility criterium is that about twice as many physiotherapy sessions are completed in the intensified physiotherapy group compared to in the usual care physiotherapy group.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- This is a pragmatic, randomized, controlled, unblinded feasibility trial with two parallel groups: an intervention group receiving intensified acute in-hospital physiotherapy (n=40) and a control group receiving usual care acute in-hospital physiotherapy (n=20).
| Arm | Type | Receives |
|---|---|---|
| Intensified physiotherapy | Experimental | Other: Intensified physiotherapyIn addition to usual care physiotherapy patients in the intensified physiotherapy group will receive an extra physiotherapy session of up to 30 minutes on every weekday starting on the first postoperative day. The session will include progressive functional training of basic mobility and walking in the ward delivered by an experienced physiotherapist affiliated with the trial. The aim of this additional session is to improve the functional advances achieved during the earlier physiotherapy session. |
| Usual care physiotherapy | Active comparator | Other: Usual care physiotherapyPatients will receive approximately 30 minutes physiotherapy once daily in the ward delivered by the ward's usual physiotherapists i.e. starting on the first postoperative day and thereafter primarily on weekdays until discharge (a mean of 8.82 days after admission). Usual care physiotherapy is individualized taking the patients ability and previous level of functioning into account and includes 1) progressive functional training of basic mobility e.g. in-out of bed, sit-to-stand and walking including progression in walking aid, stair training if possible, and advices toward better physical functional level, 2) basic bed exercises with progression to standing exercises according to a hand-out training program and recommendations on doing exercises daily and being as physical active as possible during the day. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (6 listed)
- A patient will be eligible for study participation if he/she meets the following criteria:
- Diagnosed with an isolated, first time hip fracture on the affected side
- Age ≥ 65 years
- Able to speak and understand Danish
- Home-dwelling with an independent pre-fracture ability to walk indoors (New Mobility Score (NMS) ≥ 2)
Key exclusion criteria (6 listed)
- A participant will be excluded from the study if he/she meets any of the following criteria:
- The fracture is pathological (e.g. cancer-based)
- Postoperative weight-bearing is restricted
- Multiple body fractures are present
- Serious postoperative medical complications occur
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 |
|---|---|---|
| Intensified physiotherapyPhysiotherapy x2 | Other | Intensified physiotherapy |
| Usual care physiotherapyPhysiotherapy x1 | Other | Usual care physiotherapy |
Primary outcome
Total physiotherapy completion rate during hospitalization
Time frame: Through hospital stay, an average of 8.82 days after admission.
The degree of completion (successful completion, partial completion or cancellation) of every physiotherapy session on weekdays from the first postoperative day to discharge will be rated by the physiotherapists and total physiotherapy completion rate during hospitalization will be calculated. The physiotherapists will also register cause of partial completion or cancellation.
8 secondary outcomes
Hip-fracture-related pain at rest
Time frame: Through hospital stay, an average of 8.82 days after admission.
Hip-fracture-related pain during physiotherapy
Time frame: Through hospital stay, an average of 8.82 days after admission.
Fatigue at rest
Time frame: Through hospital stay, an average of 8.82 days after admission.
Fatigue during physiotherapy
Time frame: Through hospital stay, an average of 8.82 days after admission.
Upright time during hospitalization
Time frame: From the second postoperative day to discharge, though for a maximum of 10 days after surgery.
Upright events during hospitalization
Time frame: From the second postoperative day to discharge, though for a maximum of 10 days after surgery.
Basic mobility assessed using The Cumulated Ambulation Score (CAS)
Time frame: Through hospital stay, an average of 8.82 days after admission.
Regain of pre-fracture basic mobility level at discharge
Time frame: Baseline (pre-fracture) and at discharge an average of 8.82 days after admission
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jan 2022.
- Individual participant dataSharing planned: No
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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.
Theresa Bieler, PhD study director
Bispebjerg and Frederiksberg Hospital, Dept. of Physical & Occupational Therapy
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Intensified physiotherapy in people with Hip Fractures, run by Bispebjerg Hospital at 1 site in Denmark.
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 6 inclusion and 6 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: finished, as of the sponsor's last update on 12 Jan 2022. 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 Denmark. 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.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Total physiotherapy completion rate during hospitalization (time frame: Through hospital stay, an average of 8.82 days after admission.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 12 Jan 2022.