Depressive MoodNCT02915562
Influence of Depressive Mood on Rehab Outcome
A study testing exercise in people with Depressive Mood, run by Johannes Kepler University of Linz at 1 site in Austria.
Trial summary
The purpose of this study is to determine the effects of depressive mood on outcomes of an in-house rehabilitation program. Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- Depressive Mood
- What is being tested?
- exercise
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteAustria
- Study dates
- Apr 2016to Oct 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 60 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 2-week in-house-rehab at an acute geriatric unit
- ability to take part in assessments
- understanding German language
- Informed Consent
Who cannot join
- anti-depressive medication shorter than 4 weeks before enrollment
- In-house rehab < 14 days
- advanced stage of dementia
Trial locations and contacts
1 site in 1 country.
Christian Mittermaier, M.D. contact
Austria1 site, 1 recruiting
- Recruiting
Kepler University Hospital
Linz, 4020
Christian Mittermaier, M.D., christian.mittermaier@akh.linz.at
About this study
Official title: Influence of Depressive Mood on Short Term Rehab Outcome at an Acute Geriatrics Unit
The purpose of this study is to determine the effects of depressive mood on outcomes of an in-house rehabilitation program.
- Conditions
- Depressive Mood
- Being tested
- exercise
- Keywords
- rehabilitation, exercise, outcome measurement
- Medical subject headings
- Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
exerciseOther
| Study group | Role | What they receive |
|---|---|---|
| Depressive Group | Active comparator | GDS 15 (Geriatric Depression Score) ≥5 at baseline Receives: Other: exercise |
| Non-depressive Group | Active comparator | GDS 15 (Geriatric Depression Score) <5 Points at baseline Receives: Other: exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
Physical Performance Test
Measured: Change from baseline at day 14 +/-1
de Morton Mobility Index
The de Morton Mobility index is a method for measuring changes in mobility and enhancing the continuity of patient care across clinical settings
Measured: Change from baseline at day 14 +/-1
Performance Orientated Mobility Assessment (POMA)
Task-oriented outcome measure that assesses gait and balance ability
Measured: Change from baseline at day 14 +/-1
Barthel Index
The Barthel index is an ordinal scale used to measure performance in activities of daily living
Measured: Change from baseline at day 14 +/-1
Function Index Physiotherapy
Measured: Change from baseline at day 14 +/-1
Function Index Occupational Therapy
Measured: Change from baseline at day 14 +/-1
Grip strength measurement
measured with JAMAR dynamometer
Measured: Change from baseline at day 14 +/-1
Secondary outcomes (3)
Charlson Comorbidity Index
Measure of comorbidity and multimorbidity
Measured: Day 1+/-1
Timed Test of Money Counting
Measured: Day 1+/-1
Geriatric Depression Scale (GDS-15)
Measured: Day 1+/-1 and day 14+/-1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Sep 2016 (estimated)
- Study startApr 2016
- Primary completionOct 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Depressive MoodStudies 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
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Johannes Kepler University of Linz
- Sponsor type
- University, hospital or other
- Collaborators
- Kepler University Hospital
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02915562
- Sponsor's protocol ID
- PMR-AGR-001
- Status last verified
- Sep 2016
- First submitted
- 14 Apr 2016
- Last updated
- 27 Sep 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Sep 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Influence of Depressive Mood on Short Term Rehab Outcome at an Acute Geriatrics Unit
- ClinicalTrials.gov ID
- NCT02915562
- Acronym / sponsor ID
- PMR-AGR-001
- Conditions
- Depressive Mood
- Keywords
- rehabilitation, exercise, outcome measurement
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Johannes Kepler University of LinzUniversity, hospital or other
- Collaborators
- Kepler University Hospital
- Study start
- Apr 2016
- Primary completion
- Oct 2016 (estimated)
- First posted
- 27 Sep 2016 (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 purpose of this study is to determine the effects of depressive mood on outcomes of an in-house rehabilitation program.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Depressive Group | Active comparator | Other: exerciseGDS 15 (Geriatric Depression Score) ≥5 at baseline |
| Non-depressive Group | Active comparator | Other: exerciseGDS 15 (Geriatric Depression Score) <5 Points at baseline |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 2-week in-house-rehab at an acute geriatric unit
- ability to take part in assessments
- understanding German language
- Informed Consent
Key exclusion criteria (3 listed)
- anti-depressive medication shorter than 4 weeks before enrollment
- In-house rehab < 14 days
- advanced stage of dementia
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 |
|---|---|---|
| exercise | Other | Depressive Group, Non-depressive Group |
Primary outcome
Physical Performance Test
Time frame: Change from baseline at day 14 +/-1
de Morton Mobility Index
Time frame: Change from baseline at day 14 +/-1
The de Morton Mobility index is a method for measuring changes in mobility and enhancing the continuity of patient care across clinical settings
Performance Orientated Mobility Assessment (POMA)
Time frame: Change from baseline at day 14 +/-1
Task-oriented outcome measure that assesses gait and balance ability
Barthel Index
Time frame: Change from baseline at day 14 +/-1
The Barthel index is an ordinal scale used to measure performance in activities of daily living
Function Index Physiotherapy
Time frame: Change from baseline at day 14 +/-1
Function Index Occupational Therapy
Time frame: Change from baseline at day 14 +/-1
Grip strength measurement
Time frame: Change from baseline at day 14 +/-1
measured with JAMAR dynamometer
3 secondary outcomes
Charlson Comorbidity Index
Time frame: Day 1+/-1
Timed Test of Money Counting
Time frame: Day 1+/-1
Geriatric Depression Scale (GDS-15)
Time frame: Day 1+/-1 and day 14+/-1
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Sep 2016.
- 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.
Christian Mittermaier, M.D. contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing exercise in people with Depressive Mood, run by Johannes Kepler University of Linz at 1 site in Austria.
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: status not confirmed, as of the sponsor's last update on 27 Sep 2016. 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 Austria. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Christian Mittermaier, M.D. (christian.mittermaier@akh.linz.at), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Physical Performance Test (time frame: Change from baseline at day 14 +/-1). The study lists 7 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 27 Sep 2016.