Disabled PersonsNCT03898492
Quality Assessment of a Training Period for Physical and Mentally Disabled People
A study testing Physical training in people with Disabled Persons and Exercise, run by University College of Northern Denmark at 1 site in Denmark.
Trial summary
The aim of the study was to evaluate the effect of a 8 week training period compared with control group in physical and mentally disabled adults. The effect was evaluated in relation to their physical status. Furthermore, physical activity was measured using steps and active minutes. Read more about this study
- Who is it for?
- Ages 18 to 64 yearsHealthy volunteers can take part
- Conditions the study is for
- Disabled Persons, Exercise
- What is being tested?
- Physical training
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 23 participants
- Where
- 1 siteDenmark
- Study dates
- 3 Jan 2018to 31 May 2018
- 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 to 64 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- User of the centers included in the study
- Being able to stand alone
- Being able to use an exercise bike
- Being able to understand danish
Who cannot join
- Pregnancy
- Pacemaker
- Not being able to stand up by themselves
Trial locations and contacts
1 site in 1 country.
Denmark1 site
Department of Physiotherapy, University College of Northern Jutland
Aalborg, 9220
About this study
The aim of the study was to evaluate the effect of a 8 week training period compared with control group in physical and mentally disabled adults. The effect was evaluated in relation to their physical status. Furthermore, physical activity was measured using steps and active minutes.
Read the detailed description
This study aimed at making a quality assessment of a 8 week training period for adults with physical and mental disabilities. A control group was added to compare the effect of the training with no training. Before the training period the participants were tested in relation to their physical status: weight, height, fat%, blood pressure, Aastrand test, chair stand test and waist circumference. In addition to this, the participants were instructed to wear an accelerometer to measure step and active minutes for 2-3 days a work.
The staff at the day center, where the participants works in daytime, were responsible for the physical training 2 times/week for 8 weeks. The training was an hour of combined aerobic, strength, balance and flexibility training.
The participants were tested after the training period using the same test-protocol as before.
- Conditions
- Disabled Persons, Exercise
- Being tested
- Physical training
- Medical subject headings
- Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Physical trainingOther
Training two times/week for an hour each time in 8 weeks. The training included strength training, aerobic training, balance training and flexibility training. The training was modified to the participants and initiated by the staff at the center.
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Other | The participants in this group participated in exercise two times/week for 8 weeks Receives: Other: Physical training |
| Control | No intervention | The participants in the control group were instructed to maintain their daily routines. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Body mass index
weight (kg)/height (m) x height (m)
Measured: Through study completion, an average of 8 weeks
Blood pressure
Diastolic pressure (mmHg) Systolic pressure (mmHg)
Measured: Through study completion, an average of 8 weeks
Completed chair stands
Number of completed chair stands
Measured: Through study completion, an average of 8 weeks
Aastrand test
Bike test to measure the physical fitness.
Measured: Through study completion, an average of 8 weeks
Waist circumference
Measured in cm
Measured: Through study completion, an average of 8 weeks
Physical activity
Number of steps and active minutes
Measured: During test session - 2-3 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Apr 2019
- Study start3 Jan 2018
- Primary completion31 May 2018
- Study completion31 May 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Disabled PersonsStudies 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
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- One intervention group and one control group
- Masking
- None (open label)
- Enrolment
- 23 participants (actual)
Sponsor and investigators
- Lead sponsor
- University College of Northern Denmark
- Sponsor type
- University, hospital or other
- Collaborators
- TRYG Foundation
- Responsible party
- Sponsor
- Investigators
- Dorte Drachmann, Msc, Study director, University College of Northern Jutland, Denmark. Department of Physiotherapy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03898492
- Sponsor's protocol ID
- FOU-UU-2018-001
- Status last verified
- Mar 2019
- First submitted
- 26 Mar 2019
- Last updated
- 2 Apr 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Quality Assessment of a Training Period for Physical and Mentally Disabled People
- ClinicalTrials.gov ID
- NCT03898492
- Acronym / sponsor ID
- FOU-UU-2018-001
- Conditions
- Disabled Persons, Exercise
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 23 participants (actual)
- Lead sponsor
- University College of Northern DenmarkUniversity, hospital or other
- Collaborators
- TRYG Foundation
- Study start
- 3 Jan 2018 (actual)
- Primary completion
- 31 May 2018 (actual)
- Study completion
- 31 May 2018 (actual)
- First posted
- 2 Apr 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.
The aim of the study was to evaluate the effect of a 8 week training period compared with control group in physical and mentally disabled adults. The effect was evaluated in relation to their physical status. Furthermore, physical activity was measured using steps and active minutes.
Detailed description
This study aimed at making a quality assessment of a 8 week training period for adults with physical and mental disabilities. A control group was added to compare the effect of the training with no training. Before the training period the participants were tested in relation to their physical status: weight, height, fat%, blood pressure, Aastrand test, chair stand test and waist circumference. In addition to this, the participants were instructed to wear an accelerometer to measure step and active minutes for 2-3 days a work.
The staff at the day center, where the participants works in daytime, were responsible for the physical training 2 times/week for 8 weeks. The training was an hour of combined aerobic, strength, balance and flexibility training.
The participants were tested after the training period using the same test-protocol as before.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- One intervention group and one control group
| Arm | Type | Receives |
|---|---|---|
| Intervention | Other | Other: Physical trainingThe participants in this group participated in exercise two times/week for 8 weeks |
| Control | No intervention | –The participants in the control group were instructed to maintain their daily routines. |
Who may qualify
- Ages
- 18 to 64 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- User of the centers included in the study
- Being able to stand alone
- Being able to use an exercise bike
- Being able to understand danish
Key exclusion criteria (3 listed)
- Pregnancy
- Pacemaker
- Not being able to stand up by themselves
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 |
|---|---|---|
| Physical trainingTraining two times/week for an hour each time in 8 weeks. The training included strength training, aerobic training, balance training and flexibility training. The training was modified to the participants and initiated by the staff at the center. | Other | Intervention |
Primary outcome
Body mass index
Time frame: Through study completion, an average of 8 weeks
weight (kg)/height (m) x height (m)
Blood pressure
Time frame: Through study completion, an average of 8 weeks
Diastolic pressure (mmHg) Systolic pressure (mmHg)
Completed chair stands
Time frame: Through study completion, an average of 8 weeks
Number of completed chair stands
Aastrand test
Time frame: Through study completion, an average of 8 weeks
Bike test to measure the physical fitness.
Waist circumference
Time frame: Through study completion, an average of 8 weeks
Measured in cm
Physical activity
Time frame: During test session - 2-3 days
Number of steps and active minutes
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 2 Apr 2019.
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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.
Dorte Drachmann, Msc study director
University College of Northern Jutland, Denmark. Department of Physiotherapy
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Physical training in people with Disabled Persons and Exercise, run by University College of Northern Denmark 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 4 inclusion and 3 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 2 Apr 2019. 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?
Body mass index (time frame: Through study completion, an average of 8 weeks). The study lists 6 primary outcomes in all. 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 2 Apr 2019.