Traumatic Brain InjuryINSPIRENCT06431139
Intensive Physical Exercise Versus Standard Exercise During Rehabilitation of Patients With Traumatic Brain Injury
A study testing INSPIRE intervention protocol in people with Traumatic Brain Injury, run by Christian Riberholt.
Trial summary
The aim of this randomised multicentre clinical feasibility and pilot trial is to test if a sit-to-stand trial protocol is feasible regarding the increased intensity, trial recruitment, and completion of outcome data in patients with moderate to severe traumatic brain injury during the rehabilitation phase. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Traumatic Brain Injury
- What is being tested?
- INSPIRE intervention protocol
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 44 participants
- Where
- No sites listed yet
- Study dates
- 1 Jul 2024to 31 Jan 2026
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Moderate to severe traumatic brain injury with Glasgow Coma Score <13 within the first 24 hours (ICD10, DS06)
- Admitted for rehabilitation at the Department of Brain and Spinal Cord Injury, Division of Brain Injury, Rigshospitalet, the Regional Hospital, Hammel Neurocentre or the Acquired Brain Injury Rehabilitation Centre, Alfred Hospital
- 18 years old or older
- Patients (or next of kin) should be able to understand written and spoken Danish or English to consent to participation in the trial validly
- Specifically for Australian participants: eligibility for Medicare
Who cannot join
- Unstable fractures of the lower extremities
- Amputation of lower extremity
- Spinal cord injury
- Total paralysis of both lower extremities
- Agitated or combative behaviour
- Diagnosed with a progressive neurological disorder (e.g. Alzheimer's, Parkinson's disease, multiple sclerosis) prior to traumatic brain injury, as it could potentially interfere with serum biomarker levels
- Previous structural brain injury (e.g. stroke or brain surgery)
- No valid consent from the participant or next of kin
Trial locations and contacts
No sites are listed yet.
Christian G Riberholt, PT, MR, PhD contact
About this study
Official title: Intensive Physical Exercise Versus Standard Exercise During Rehabilitation of Patients With Traumatic Brain Injury - a Randomised Pilot and Feasibility Trial
The aim of this randomised multicentre clinical feasibility and pilot trial is to test if a sit-to-stand trial protocol is feasible regarding the increased intensity, trial recruitment, and completion of outcome data in patients with moderate to severe traumatic brain injury during the rehabilitation phase. For the trial to be feasible, all outcomes must be achieved.
The primary hypothesis is that it is feasible to progressively increase the number of repetitions of sit-to-stand exercises in patients with moderate to severe traumatic brain injury admitted to a rehabilitation department during the intervention period.
Furthermore, the investigators hypothesize that the increased number of repetitions will increase the participant's functional capabilities regarding sit-to-stand and walking, decrease resting heart rate, blood pressure, and metabolism, reduce inflammatory and brain injury biomarkers, and improve the cognitive performance.
Read the detailed description
This is a randomised multicentre clinical feasibility and pilot trial, where assessors and statisticians will be blinded. Forty-four participants with moderate to severe traumatic brain injury will be randomised to INSPIRE versus standard care as soon as they are able to understand and execute simple commands twice during one day. Participants in the INSPIRE group will undergo two weeks of intensive sit-to-stand exercise using an algorithm to increase the intensity daily. The trial uses predefined dose-limiting events to reduce training intensity in participants experiencing exercise-related adverse events that limit other daily activities and rehabilitation (e.g. muscle soreness and pain). Overall feasibility will be assessed by determining the inclusion rate, exercise completion rate, and completion of the Glasgow Outcome Scale - Extended. As exploratory clinical outcomes, the investigators will assess serious adverse events and adverse events not considered serious, physical function, cardiovascular and metabolic health, fatigue, and cognitive function.
- Conditions
- Traumatic Brain Injury
- Being tested
- INSPIRE intervention protocol
- Keywords
- Traumatic brain injury, Intensive exercise, Rehabilitation, Randomised trial, Feasibility, Pilot, Sit-to-stand exercise
- Medical subject headings
- Brain Injuries, Traumatic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
INSPIRE intervention protocolOther
2-week training program with daily sit-to-stand exercises. Each working day the participant's goals will be adjusted, until exercising a minimum of 100 repetitions using an exercise progression table. When participants complete one level, they will progress to the next level the following day. Participants who do not reach the goals at level one will continue to strive to reach the 100 repetitions. The number of repetitions can be split and performed throughout the day. As the participants' capacity for doing the exercises increases, so will the number of repetitions within each bout of sit-to-stand. Participants are allowed to do the number of repetitions from a higher exercise level if they can and will continue by progressing from that level on the next day. The repetitions will be done from a height that makes it possible to accomplish the sit-to-stand movement. Therefore, the height of the sitting surface will be adjusted according to the participant's abilities.
| Study group | Role | What they receive |
|---|---|---|
| INSPIRE group | Experimental | Intervention group. Daily intensive sit-to-stand exercises following a described algorithm and utilising motor-relearning principles of feedback to increase the participant's motivation. This exercise is an addition to standard care. Receives: Other: INSPIRE intervention protocol |
| Standard care group | No intervention | Treatment in this group will be standard care interventions performed at the rehabilitation department. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of sit-to-stand
The difference in the number of sit-to-stand performed in the INSPIRE group compared to the control group using linear regression during the two-week intervention period.
Measured: during the intervention
Secondary outcomes (2)
The number of participants included in the trial
Of all eligible patients, at least 76% (95% CI 63% to 86%, 1-sample proportions test with continuity correction) must consent (by themselves or by proxy) to inclusion in the trial, corresponding to 44/58 eligible patients included
Measured: 1,5 years
Participants completing GOSE
The number of participants completing the Glasgow Outcome Scale extended at six months and one year must be above 89% (95% CI 76% to 96%), corresponding to 40/44 participants.
Measured: 6 months, 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 May 2024
- Study start1 Jul 2024 (estimated)
- Primary completion31 Oct 2025 (estimated)
- Study completion31 Jan 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Traumatic Brain InjuryStudies 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 44 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Christian Riberholt
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Christian Riberholt, Copenhagen University Hospital, Rigshospitalet
- Investigators
- Christian G Riberholt, PT, MR, PhD, Study director, Dept. of Brain and Spinal Cord Injury, Division of Brain Injury, Copenhagen University Hospital - RigshospitaletChristina G Kruuse, Professor, Study director, Dept. of Brain and Spinal Cord Injury, Division of Brain Injury, Copenhagen University Hospital - Rigshospitalet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06431139
- Sponsor's protocol ID
- H-24001505
- Acronym
- INSPIRE
- Status last verified
- May 2024
- First submitted
- 7 May 2024
- Last updated
- 28 May 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intensive Physical Exercise Versus Standard Exercise During Rehabilitation of Patients With Traumatic Brain Injury - a Randomised Pilot and Feasibility Trial
- ClinicalTrials.gov ID
- NCT06431139
- Acronym / sponsor ID
- INSPIRE / H-24001505
- Conditions
- Traumatic Brain Injury
- Keywords
- Traumatic brain injury, Intensive exercise, Rehabilitation, Randomised trial, Feasibility, Pilot, Sit-to-stand exercise
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 44 participants (estimated)
- Lead sponsor
- Christian RiberholtUniversity, hospital or other
- Study start
- 1 Jul 2024 (estimated)
- Primary completion
- 31 Oct 2025 (estimated)
- Study completion
- 31 Jan 2026 (estimated)
- First posted
- 28 May 2024 (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.
The aim of this randomised multicentre clinical feasibility and pilot trial is to test if a sit-to-stand trial protocol is feasible regarding the increased intensity, trial recruitment, and completion of outcome data in patients with moderate to severe traumatic brain injury during the rehabilitation phase. For the trial to be feasible, all outcomes must be achieved.
The primary hypothesis is that it is feasible to progressively increase the number of repetitions of sit-to-stand exercises in patients with moderate to severe traumatic brain injury admitted to a rehabilitation department during the intervention period.
Furthermore, the investigators hypothesize that the increased number of repetitions will increase the participant's functional capabilities regarding sit-to-stand and walking, decrease resting heart rate, blood pressure, and metabolism, reduce inflammatory and brain injury biomarkers, and improve the cognitive performance.
Detailed description
This is a randomised multicentre clinical feasibility and pilot trial, where assessors and statisticians will be blinded. Forty-four participants with moderate to severe traumatic brain injury will be randomised to INSPIRE versus standard care as soon as they are able to understand and execute simple commands twice during one day. Participants in the INSPIRE group will undergo two weeks of intensive sit-to-stand exercise using an algorithm to increase the intensity daily. The trial uses predefined dose-limiting events to reduce training intensity in participants experiencing exercise-related adverse events that limit other daily activities and rehabilitation (e.g. muscle soreness and pain). Overall feasibility will be assessed by determining the inclusion rate, exercise completion rate, and completion of the Glasgow Outcome Scale - Extended. As exploratory clinical outcomes, the investigators will assess serious adverse events and adverse events not considered serious, physical function, cardiovascular and metabolic health, fatigue, and cognitive function.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| INSPIRE group | Experimental | Other: INSPIRE intervention protocolIntervention group. Daily intensive sit-to-stand exercises following a described algorithm and utilising motor-relearning principles of feedback to increase the participant's motivation. This exercise is an addition to standard care. |
| Standard care group | No intervention | –Treatment in this group will be standard care interventions performed at the rehabilitation department. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Moderate to severe traumatic brain injury with Glasgow Coma Score <13 within the first 24 hours (ICD10, DS06)
- Admitted for rehabilitation at the Department of Brain and Spinal Cord Injury, Division of Brain Injury, Rigshospitalet, the Regional Hospital, Hammel Neurocentre or the Acquired Brain Injury Rehabilitation Centre, Alfred Hospital
- 18 years old or older
- Patients (or next of kin) should be able to understand written and spoken Danish or English to consent to participation in the trial validly
- Specifically for Australian participants: eligibility for Medicare
Key exclusion criteria (8 listed)
- Unstable fractures of the lower extremities
- Amputation of lower extremity
- Spinal cord injury
- Total paralysis of both lower extremities
- Agitated or combative behaviour
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 |
|---|---|---|
| INSPIRE intervention protocol2-week training program with daily sit-to-stand exercises. Each working day the participant's goals will be adjusted, until exercising a minimum of 100 repetitions using an exercise progression table. When participants complete one level, they will progress to the next level the following day. Participants who do not reach the goals at level one will continue to strive to reach the 100 repetitions. The number of repetitions can be split and performed throughout the day. As the participants' capacity for doing the exercises increases, so will the number of repetitions within each bout of sit-to-stand. Participants are allowed to do the number of repetitions from a higher exercise level if they can and will continue by progressing from that level on the next day. The repetitions will be done from a height that makes it possible to accomplish the sit-to-stand movement. Therefore, the height of the sitting surface will be adjusted according to the participant's abilities. | Other | INSPIRE group |
Primary outcome
Number of sit-to-stand
Time frame: during the intervention
The difference in the number of sit-to-stand performed in the INSPIRE group compared to the control group using linear regression during the two-week intervention period.
2 secondary outcomes
The number of participants included in the trial
Time frame: 1,5 years
Participants completing GOSE
Time frame: 6 months, 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 May 2024.
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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.
Christian G Riberholt, PT, MR, PhD contact
Christian G Riberholt, PT, MR, PhD study director
Dept. of Brain and Spinal Cord Injury, Division of Brain Injury, Copenhagen University Hospital - Rigshospitalet
Christina G Kruuse, Professor study director
Dept. of Brain and Spinal Cord Injury, Division of Brain Injury, Copenhagen University Hospital - Rigshospitalet
Questions about this trial
What is this clinical trial studying?
A study testing INSPIRE intervention protocol in people with Traumatic Brain Injury, run by Christian Riberholt.
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 8 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 28 May 2024. 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 Yasemin Ronahi Kücük, M.D (+4527841237, yasemin.ronahi.kuecuek@regionh.dk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of sit-to-stand (time frame: during the intervention). 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 28 May 2024.