Rehabilitation of Muscle StrengthREHABNCT01770821
Rehabilitation After Intensive Care
A study testing Dietary supplement and/or physical training in people with Rehabilitation of Muscle Strength, run by Haukeland University Hospital.
Trial summary
Patients with critical illness loose bodymass, mainly muscle. The purpose of the present study is to evaluate wheather tailored physical training and/or a sip drink (proteinrich) have effect on the six minutes walking test (6MWT), muscle strength, body weight, body composition and quality of life after intensive care. Read more about this study
- Who is it for?
- Ages 45 years and older
- Conditions the study is for
- Rehabilitation of Muscle Strength
- What is being tested?
- Dietary supplement and/or physical training
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Feb 2013to Dec 2016
- 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 45 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- ICU patients ≥45 years with LOS ≥ 5days
Who cannot join
- Patients < 45 years, Cerebral function that make cooperation impossible, Fractures in the spine, pelvis and/or lower extremities, Unable to perform the intervention LOS < 5 days
About this study
Official title: REHABILITATION AFTER INTENSIVE CARE What Effect Does Physiotherapy and Proteinrich Sip Drink Have on Physical Performance, Bodycomposition, Bodyweight and Quality of Life?
Patients with critical illness loose bodymass, mainly muscle. The purpose of the present study is to evaluate wheather tailored physical training and/or a sip drink (proteinrich) have effect on the six minutes walking test (6MWT), muscle strength, body weight, body composition and quality of life after intensive care. This is a single center randomised controled study comprising patients ≥45 years of age staying 5 days or more in the intensive care unit (ICU). The design is factorial. Inclusion takes place when the patient is leaving the ICU.
- Conditions
- Rehabilitation of Muscle Strength
- Being tested
- Dietary supplement and/or physical training
- Keywords
- sip drink, protein, muscle strength, 6 minutes walking test
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dietary supplement and/or physical trainingOther
| Study group | Role | What they receive |
|---|---|---|
| Standard physical training & standard nutrition | Active comparator | Standard of care Receives: Other: Dietary supplement and/or physical training |
| Tailored physical training and sipdrink | Experimental | Tailored physical training and sipdrink (Protein nutridrink, 200 ml x 2) Receives: Other: Dietary supplement and/or physical training |
| Tailored physical training and standard nutrition. | Experimental | Standard physical training provided by the hospital and standard hospital nutrition Receives: Other: Dietary supplement and/or physical training |
| Standard physical training and sip drink | Experimental | Standard physical training provided by the hospital and sipdrink (Nutridrink protein, 200 ml x2) Receives: Other: Dietary supplement and/or physical training |
What is being measured
The primary outcome is the main question the study is designed to answer.
6 minutes walking test (6MWT) (when the patient leave hospital, 12 weeks and 12 months)
Measured: One year
Secondary outcomes (1)
Isometric quadriceps strength, Isometrisk handgrip strength, Bodyweight Bodycomposition (Dexa)
Measured: One year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jan 2013 (estimated)
- Study startFeb 2013 (estimated)
- Primary completionFeb 2016 (estimated)
- Study completionDec 2016 (estimated)
Why it stopped: Lack of resource
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Rehabilitation of Muscle StrengthStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Haukeland University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01770821
- Sponsor's protocol ID
- 2009-2134
- Other IDs
- Innovest
- Acronym
- REHAB
- Status last verified
- Feb 2024
- First submitted
- 16 Jan 2013
- Last updated
- 1 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- REHABILITATION AFTER INTENSIVE CARE What Effect Does Physiotherapy and Proteinrich Sip Drink Have on Physical Performance, Bodycomposition, Bodyweight and Quality of Life?
- ClinicalTrials.gov ID
- NCT01770821
- Acronym / sponsor ID
- REHAB / 2009-2134
- Conditions
- Rehabilitation of Muscle Strength
- Keywords
- sip drink, protein, muscle strength, 6 minutes walking test
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Lack of resource
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Haukeland University HospitalUniversity, hospital or other
- Study start
- Feb 2013 (estimated)
- Primary completion
- Feb 2016 (estimated)
- Study completion
- Dec 2016 (estimated)
- First posted
- 18 Jan 2013 (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.
Patients with critical illness loose bodymass, mainly muscle. The purpose of the present study is to evaluate wheather tailored physical training and/or a sip drink (proteinrich) have effect on the six minutes walking test (6MWT), muscle strength, body weight, body composition and quality of life after intensive care. This is a single center randomised controled study comprising patients ≥45 years of age staying 5 days or more in the intensive care unit (ICU). The design is factorial. Inclusion takes place when the patient is leaving the ICU.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Standard physical training & standard nutrition | Active comparator | Other: Dietary supplement and/or physical trainingStandard of care |
| Tailored physical training and sipdrink | Experimental | Other: Dietary supplement and/or physical trainingTailored physical training and sipdrink (Protein nutridrink, 200 ml x 2) |
| Tailored physical training and standard nutrition. | Experimental | Other: Dietary supplement and/or physical trainingStandard physical training provided by the hospital and standard hospital nutrition |
| Standard physical training and sip drink | Experimental | Other: Dietary supplement and/or physical trainingStandard physical training provided by the hospital and sipdrink (Nutridrink protein, 200 ml x2) |
Who may qualify
- Ages
- 45 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- ICU patients ≥45 years with LOS ≥ 5days
Key exclusion criteria (1 listed)
- Patients < 45 years, Cerebral function that make cooperation impossible, Fractures in the spine, pelvis and/or lower extremities, Unable to perform the intervention LOS < 5 days
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 |
|---|---|---|
| Dietary supplement and/or physical training | Other | Standard physical training & standard nutrition, Standard physical training and sip drink, Tailored physical training and sipdrink, Tailored physical training and standard nutrition. |
Primary outcome
6 minutes walking test (6MWT) (when the patient leave hospital, 12 weeks and 12 months)
Time frame: One year
1 secondary outcome
Isometric quadriceps strength, Isometrisk handgrip strength, Bodyweight Bodycomposition (Dexa)
Time frame: One year
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Mar 2024.
Related trials for Rehabilitation of Muscle Strength
Not yet recruiting
Feasibility of Resisted Expiratory Muscle Training for Females Assigned at Birth With Stress Urinary Incontinence: A Pilot Study
Stress Urinary Incontinence
Recruiting
HABIT-ILE + FST in Children With SMA: Preliminary Effectiveness
Spinal Muscular Atrophy (SMA)
Not yet recruiting
Dry Needling and Quad Strength After Anterior Cruciate Ligament Reconstruction
Anterior Cruciate Ligament Reconstruction Rehabilitation, Dry Needling
Not yet recruiting
Effects of Respiratory Muscle Strength Training in Children With Asthma
Asthma (Diagnosis)
Active, not recruiting
Comparative Effects of Balance and Inspiratory Muscle Training in Older Adults
Geriatric, Geriatrics Rehabilitation
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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Dietary supplement and/or physical training in people with Rehabilitation of Muscle Strength, run by Haukeland University Hospital.
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 1 inclusion and 1 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: withdrawn, as of the sponsor's last update on 1 Mar 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?
The study was withdrawn before enrolling participants, so there are no results.
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?
6 minutes walking test (6MWT) (when the patient leave hospital, 12 weeks and 12 months) (time frame: One year). 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 1 Mar 2024.