Medical DiseasesB15NCT01371097
Progressive Resistance Strength Training (PRT) in Hospitalised Elderly Patients
A study testing Progressive Resistance strength training in people with Medical Diseases and Neurological Diseases, run by Glostrup University Hospital, Copenhagen at 1 site in Denmark.
Trial summary
The aim of the study is to evaluate the effect of progressive resistance strength training (PRT) in elderly hospitalised patients. The hypothesis is that PRT given as an additional training would improve the rehabilitation and increase the level of activity of daily living. Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- Medical Diseases, Neurological Diseases, Chronical Obstructive Lung Diseases
- What is being tested?
- Progressive Resistance strength training
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 71 participants
- Where
- 1 siteDenmark
- Study dates
- Sep 2006to Jan 2008
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Hospitalised elderly patients referred for physiotherapy.
- Ability to perform standing position independently with/without walking aids (rollator, crutch) or bed/bench support.
Who cannot join
- Expected length of stay < 7 days.
- Dementia.
- Unable to communicate relevant.
- Unable to be active
Trial locations and contacts
1 site in 1 country.
Denmark1 site
Copenhagen University Hospital, Glostrup
Glostrup Municipality, DK-2600
About this study
Official title: The Effect of Progressive Resistance Strength Training in Hospitalised Elderly Patients
The aim of the study is to evaluate the effect of progressive resistance strength training (PRT) in elderly hospitalised patients. The hypothesis is that PRT given as an additional training would improve the rehabilitation and increase the level of activity of daily living.
Read the detailed description
Elderly inpatients included in the study were randomised into a control group or a training group. All included patients received the regular in-physiotherapy, but the training group received progressive resistance training in groups in addition.
- Being tested
- Progressive Resistance strength training
- Keywords
- Barthel Index, elderly hospitalised patients, progressive resistance training
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Progressive Resistance strength trainingOther
Resistance strength training is given as circle training. The resistance is increased with regularly intervals.
| Study group | Role | What they receive |
|---|---|---|
| Control Group | No intervention | Not described |
| Treatment group | Experimental | Not described Receives: Other: Progressive Resistance strength training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Timed "Up & Go" Test
The Timed Up \& Go (TUG) test assess basic functional mobility.(14). The test measures the time (in seconds)that the subjects used for standing up from the seating position on a chair (chair seat height = 45 cm) with armrest, walking 3 m, turning around and walking back to the chair and sitting down again.
Measured: Before randomisation and 3 days before discharge from the department
Secondary outcomes (1)
Barthel Index
BI consists of 10 functional tasks of which 3 tasks focus the function of mowing and walking. Task numbers 8 in BI "Transfer" assess the ability to move and are rated on a 0, 5 and10 point ordinal scale. Task number 9 in BI "Walking" assess the ability to walk rated on a 0, 5 or 10 point scale.
Task number 10 in BI "Stairs" assesses the ability to walk on stairs and is rated with 0, 5, 10 or 15 points.
Measured: before randomisation and 3 days before discharge from the department
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jun 2011 (estimated)
- Study startSep 2006
- Primary completionJan 2008
- Study completionJan 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Medical DiseasesStudies 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
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 71 participants (actual)
Sponsor and investigators
- Lead sponsor
- Glostrup University Hospital, Copenhagen
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sigrid Tibaek, Glostrup University Hospital, Copenhagen
- Investigators
- Sigrid Tibaek, Dr Med Sci, PT, Principal investigator, Glostrup University Hospital, Copenhagen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01371097
- Sponsor's protocol ID
- H-KA-2006-0144
- Acronym
- B15
- Status last verified
- Mar 2015
- First submitted
- 9 Jun 2011
- Last updated
- 11 Mar 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 11 Mar 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Progressive Resistance Strength Training in Hospitalised Elderly Patients
- ClinicalTrials.gov ID
- NCT01371097
- Acronym / sponsor ID
- B15 / H-KA-2006-0144
- Keywords
- Barthel Index, elderly hospitalised patients, progressive resistance training
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 71 participants (actual)
- Lead sponsor
- Glostrup University Hospital, CopenhagenUniversity, hospital or other
- Study start
- Sep 2006
- Primary completion
- Jan 2008 (actual)
- Study completion
- Jan 2008 (actual)
- First posted
- 10 Jun 2011 (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 the study is to evaluate the effect of progressive resistance strength training (PRT) in elderly hospitalised patients. The hypothesis is that PRT given as an additional training would improve the rehabilitation and increase the level of activity of daily living.
Detailed description
Elderly inpatients included in the study were randomised into a control group or a training group. All included patients received the regular in-physiotherapy, but the training group received progressive resistance training in groups in addition.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control Group | No intervention | – |
| Treatment group | Experimental | Other: Progressive Resistance strength training |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Hospitalised elderly patients referred for physiotherapy.
- Ability to perform standing position independently with/without walking aids (rollator, crutch) or bed/bench support.
Key exclusion criteria (4 listed)
- Expected length of stay < 7 days.
- Dementia.
- Unable to communicate relevant.
- Unable to be active
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 |
|---|---|---|
| Progressive Resistance strength trainingResistance strength training is given as circle training. The resistance is increased with regularly intervals. | Other | Treatment group |
Primary outcome
Timed "Up & Go" Test
Time frame: Before randomisation and 3 days before discharge from the department
The Timed Up \& Go (TUG) test assess basic functional mobility.(14). The test measures the time (in seconds)that the subjects used for standing up from the seating position on a chair (chair seat height = 45 cm) with armrest, walking 3 m, turning around and walking back to the chair and sitting down again.
1 secondary outcome
Barthel Index
Time frame: before randomisation and 3 days before discharge from the department
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 11 Mar 2015.
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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.
Sigrid Tibaek, Dr Med Sci, PT principal investigator
Glostrup University Hospital, Copenhagen
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Progressive Resistance strength training in people with Medical Diseases and Neurological Diseases, run by Glostrup University Hospital, Copenhagen 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 2 inclusion and 4 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 11 Mar 2015. 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?
Timed "Up & Go" Test (time frame: Before randomisation and 3 days before discharge from the department). 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 11 Mar 2015.