Quality of LifeNCT01204567
The Influence of Exercise on Mental Health After Discharge From Hospital
A study testing Aerobic training in people with Quality of Life, run by Oslo University Hospital at 1 site in Norway.
Trial summary
The aim of this study is to evaluate the effect of aerobic fitness training on mental health (health-related quality of life),cognitive and physical capacity in older people discharge from hospital and to assess if further aerobic training at home enhances the effect. Read more about this study
- Who is it for?
- Ages 70 years and olderHealthy volunteers can take part
- Conditions the study is for
- Quality of Life
- What is being tested?
- Aerobic training
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 116 participants
- Where
- 1 siteNorway
- Study dates
- Jan 2010to Aug 2012
- 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 70 years and older
- All sexes
- Healthy volunteers accepted
- Older adult
Who may be able to join
- 70 years or older
- Be able to perform the Timed Up and Go test without use of assistive device
Who cannot join
- Chronic disease with expected lifespan < 1 year
- Exercise regularly more than twice a week
- Cognitive impairment MMS < 24
- Assessed by a doctor not to tolerate aerobic exercises
- Exercise limiting cardiovascular or musculoskeletal disease
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Aim of the Study is to Evaluate the Effect of Aerobic Fitness Training on Mental Health (Health-related Quality of Life), Cognitive and Physical Capacity in Older People Discharged From Hospital.
The aim of this study is to evaluate the effect of aerobic fitness training on mental health (health-related quality of life),cognitive and physical capacity in older people discharge from hospital and to assess if further aerobic training at home enhances the effect.
Design: Randomized controlled trial conducted at Oslo University Hospital, department of Medicine in conjunction with Oslo University College. The subjects will be randomized into one intervention group (training group) or one control group.
Outcome measure:
Health-related quality of life Physical function Cognitive capacity Physical activity Body composition Physical activity level
Read the detailed description
Research has indicated that participation in a regular exercise program is an effective intervention to maintain and enhance cognitive and physical function in older individuals.Despite good evidence regarding the positive effects of exercise, a sedentary or inactive lifestyle is common among people over 65 years of old, especially among persons with chronic diseases. Research shows that good mental health and physical capacity is of vital importance for living independently in the community and we know that participation in physical activity offers good opportunities to extend years of active independent life. Nevertheless our knowledge is sparse regarding the evidence of effective programs for health promotion in groups of elderly, especially after discharge from hospital. Our knowledge is also sparse as to which intervention program is the most effective, group-based training or home- based training.
- Conditions
- Quality of Life
- Being tested
- Aerobic training
- Keywords
- HLRQ, elderly, aerobic fitness, cognitive capacity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Aerobic trainingOther
Also called 1 intervention group, 1 control group no follow-up
Group-based Aerobic Interval Training twice a week in 12 weeks, based on the Ulleval model. The Norwegian Ulleval Model is a group-based aerobic interval training program which is widely used in Scandinavian hospitals for patients with coronary disease. It is designed to improve physical capacity, body awareness and emotional well-being.
| Study group | Role | What they receive |
|---|---|---|
| Training follow-up after discharge | Active comparator | Aerobic training Home-program Receives: Other: Aerobic training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Health-related quality of life. Short form Health Survey (SF-36, version 2
Measured: 3 and 12 months
Secondary outcomes (1)
Senior fitness test, Cognitive capacity, PASE
Measured: 3 and 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Sep 2010 (estimated)
- Study startJan 2010
- Primary completionAug 2012
- Study completionAug 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Quality of LifeStudies of the same condition, open and under way.
- More trials run by Oslo University HospitalThe sponsor's other registered studies.
- 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
- 116 participants (actual)
Sponsor and investigators
- Lead sponsor
- Oslo University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Oslo University College
- Responsible party
- Sponsor
- Investigators
- Therese Brovold, phd student, Principal investigator, no afflication
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01204567
- Sponsor's protocol ID
- 2009/184a
- Status last verified
- Aug 2012
- First submitted
- 10 Sep 2010
- Last updated
- 24 Aug 2012
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 24 Aug 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Aim of the Study is to Evaluate the Effect of Aerobic Fitness Training on Mental Health (Health-related Quality of Life), Cognitive and Physical Capacity in Older People Discharged From Hospital.
- ClinicalTrials.gov ID
- NCT01204567
- Acronym / sponsor ID
- 2009/184a
- Conditions
- Quality of Life
- Keywords
- HLRQ, elderly, aerobic fitness, cognitive capacity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 116 participants (actual)
- Lead sponsor
- Oslo University HospitalUniversity, hospital or other
- Collaborators
- Oslo University College
- Study start
- Jan 2010
- Primary completion
- Aug 2012 (actual)
- Study completion
- Aug 2012 (actual)
- First posted
- 17 Sep 2010 (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 this study is to evaluate the effect of aerobic fitness training on mental health (health-related quality of life),cognitive and physical capacity in older people discharge from hospital and to assess if further aerobic training at home enhances the effect.
Design: Randomized controlled trial conducted at Oslo University Hospital, department of Medicine in conjunction with Oslo University College. The subjects will be randomized into one intervention group (training group) or one control group.
Outcome measure:
Health-related quality of life Physical function Cognitive capacity Physical activity Body composition Physical activity level
Detailed description
Research has indicated that participation in a regular exercise program is an effective intervention to maintain and enhance cognitive and physical function in older individuals.Despite good evidence regarding the positive effects of exercise, a sedentary or inactive lifestyle is common among people over 65 years of old, especially among persons with chronic diseases. Research shows that good mental health and physical capacity is of vital importance for living independently in the community and we know that participation in physical activity offers good opportunities to extend years of active independent life. Nevertheless our knowledge is sparse regarding the evidence of effective programs for health promotion in groups of elderly, especially after discharge from hospital. Our knowledge is also sparse as to which intervention program is the most effective, group-based training or home- based training.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Training follow-up after discharge | Active comparator | Other: Aerobic trainingAerobic training Home-program |
Who may qualify
- Ages
- 70 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (2 listed)
- 70 years or older
- Be able to perform the Timed Up and Go test without use of assistive device
Key exclusion criteria (5 listed)
- Chronic disease with expected lifespan < 1 year
- Exercise regularly more than twice a week
- Cognitive impairment MMS < 24
- Assessed by a doctor not to tolerate aerobic exercises
- Exercise limiting cardiovascular or musculoskeletal disease
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 |
|---|---|---|
| Aerobic trainingAlso: 1 intervention group, 1 control group no follow-upGroup-based Aerobic Interval Training twice a week in 12 weeks, based on the Ulleval model. The Norwegian Ulleval Model is a group-based aerobic interval training program which is widely used in Scandinavian hospitals for patients with coronary disease. It is designed to improve physical capacity, body awareness and emotional well-being. | Other | Training follow-up after discharge |
Primary outcome
Health-related quality of life. Short form Health Survey (SF-36, version 2
Time frame: 3 and 12 months
1 secondary outcome
Senior fitness test, Cognitive capacity, PASE
Time frame: 3 and 12 months
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 24 Aug 2012.
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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.
Therese Brovold, phd student principal investigator
no afflication
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Aerobic training in people with Quality of Life, run by Oslo University Hospital at 1 site in Norway.
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 5 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 24 Aug 2012. 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 Norway. 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?
Health-related quality of life. Short form Health Survey (SF-36, version 2 (time frame: 3 and 12 months). 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 24 Aug 2012.