Health-Related Quality of LifePhase 2NCT01247636
Home-Exercise vs General Physical Activity: Effect on Health-related Quality of Life
A Phase 2 study testing Balance- training and home-exercise and Balance-training and home-exercise in people with Health-Related Quality of Life, run by Oslo University Hospital at 1 site in Norway.
Trial summary
The purpose of this randomized controlled trial is to evaluate the effectiveness of an exercised-based programme developed for older people admitted at a geriatric outpatient clinic and to see if a home-exercise program enhances the effect. Read more about this study
- Who is it for?
- Ages 60 years and olderHealthy volunteers can take part
- Conditions the study is for
- Health-Related Quality of Life
- What is being tested?
- Balance- training and home-exercise and Balance-training and home-exercise
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 110 participants
- Where
- 1 siteNorway
- Study dates
- Jan 2005to Jan 2007
- Phase
- Phase 2
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- home-dwelling patients who were admitted at the geriatric clinic.
- Assessed by a doctor to tolerate training
- Able to walk in the corridor for 3 min with or without assistive device
Who cannot join
- Cognitive disorders mini mental status < 24
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Progressive Home-Exercise on Health-related Quality of Life, Balance and Mobility in Older People Discharge From an Outpatient Geriatric Clinic.
The purpose of this randomized controlled trial is to evaluate the effectiveness of an exercised-based programme developed for older people admitted at a geriatric outpatient clinic and to see if a home-exercise program enhances the effect. The outcomes considered is health-related quality of life, balance-self confidence, balance and mobility.
Read the detailed description
Older people discharge from hospital often have decreased functional and physiological reserve that make them vulnerable of being dependent of others. Research have shown that older people discharge from hospital are vulnerable for functional decline during hospital stay and this decline can persist 6 to 18 months after discharge from hospital.Exercise interventions are proven to have effect on mobility, balance and falls among community-dwelling older people and several studies have shown that deconditioning as a consequence of disuse is reversible with training even in very old individuals. However, few studies have evaluated the effects of physical activity promotion and exercise intervention among elderly recently discharge from a geriatric outpatient clinic.
- Conditions
- Health-Related Quality of Life
- Being tested
- Balance- training and home-exercise, Balance-training and home-exercise
- Keywords
- HLRQ, Elderly, Balance, Mobility, Fear of falling
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Balance- training and home-exerciseOther
Also called 1 intervention group, 1 control group
Balance-training admitted at the geriatric hospital Home-exercise or advice to be generally active
Balance-training and home-exerciseOther
Also called 1 home-exercise group, 1 activity group
The aim of the intervention was to enhance health-related quality of life, self-efficacy and physical function through education and exercise. The education program consisted of information given both oral and in writing regarding the benefits of physical activity. The aim was to increase the participants knowledge about the benefits of physical activity and to stimulate them to integrate physical activity into their immediate environment during daily routines. They were given an exercise-log and were advised to write down all their daily activities and exercise. The exercise program were conducted 2 times per week for 45 min per session. The content of these sessions were balance training with main focus on balance-exercises considered essential for daily living.
| Study group | Role | What they receive |
|---|---|---|
| Home-exercise | Experimental | Not described Receives: Other: Balance- training and home-exercise; Other: Balance-training and home-exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
Health-related quality of life
Measured: by the time of discharge mean 2 weeks after admission
Health-related quality of life
Measured: 3 months
Secondary outcomes (3)
Functional balance (Berg Balance Scale)
Measured: by the time of discharge mean 2 weeks after admission and after 3 months
Functional mobility
Timed up and go test and 6 min walk test
Measured: by the time of discharge mean 2 weeks after admission, and after 3 months
Functional strength
Measured: by the time of discharge mean 2 weeks after admission and after 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Nov 2010 (estimated)
- Study startJan 2005
- Primary completionJan 2007
- Study completionJan 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Health-Related 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 110 participants (actual)
Sponsor and investigators
- Lead sponsor
- Oslo University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Norwegian Fund for Postgraduate Training in Physiotherapy
- Investigators
- Astrid Bergland, Professor, Study chair, No afflication
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01247636
- Sponsor's protocol ID
- S-03247
- Status last verified
- Jan 2005
- First submitted
- 18 Nov 2010
- Last updated
- 24 Nov 2010
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Nov 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Progressive Home-Exercise on Health-related Quality of Life, Balance and Mobility in Older People Discharge From an Outpatient Geriatric Clinic.
- ClinicalTrials.gov ID
- NCT01247636
- Acronym / sponsor ID
- S-03247
- Conditions
- Health-Related Quality of Life
- Keywords
- HLRQ, Elderly, Balance, Mobility, Fear of falling
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 110 participants (actual)
- Lead sponsor
- Oslo University HospitalUniversity, hospital or other
- Collaborators
- Norwegian Fund for Postgraduate Training in Physiotherapy
- Study start
- Jan 2005
- Primary completion
- Jan 2007 (actual)
- Study completion
- Jan 2007 (actual)
- First posted
- 24 Nov 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 purpose of this randomized controlled trial is to evaluate the effectiveness of an exercised-based programme developed for older people admitted at a geriatric outpatient clinic and to see if a home-exercise program enhances the effect. The outcomes considered is health-related quality of life, balance-self confidence, balance and mobility.
Detailed description
Older people discharge from hospital often have decreased functional and physiological reserve that make them vulnerable of being dependent of others. Research have shown that older people discharge from hospital are vulnerable for functional decline during hospital stay and this decline can persist 6 to 18 months after discharge from hospital.Exercise interventions are proven to have effect on mobility, balance and falls among community-dwelling older people and several studies have shown that deconditioning as a consequence of disuse is reversible with training even in very old individuals. However, few studies have evaluated the effects of physical activity promotion and exercise intervention among elderly recently discharge from a geriatric outpatient clinic.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Home-exercise | Experimental | Other: Balance- training and home-exercise, Other: Balance-training and home-exercise |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- home-dwelling patients who were admitted at the geriatric clinic.
- Assessed by a doctor to tolerate training
- Able to walk in the corridor for 3 min with or without assistive device
Key exclusion criteria (1 listed)
- Cognitive disorders mini mental status < 24
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 |
|---|---|---|
| Balance- training and home-exerciseAlso: 1 intervention group, 1 control groupBalance-training admitted at the geriatric hospital Home-exercise or advice to be generally active | Other | Home-exercise |
| Balance-training and home-exerciseAlso: 1 home-exercise group, 1 activity groupThe aim of the intervention was to enhance health-related quality of life, self-efficacy and physical function through education and exercise. The education program consisted of information given both oral and in writing regarding the benefits of physical activity. The aim was to increase the participants knowledge about the benefits of physical activity and to stimulate them to integrate physical activity into their immediate environment during daily routines. They were given an exercise-log and were advised to write down all their daily activities and exercise. The exercise program were conducted 2 times per week for 45 min per session. The content of these sessions were balance training with main focus on balance-exercises considered essential for daily living. | Other | Home-exercise |
Primary outcome
Health-related quality of life
Time frame: by the time of discharge mean 2 weeks after admission
Health-related quality of life
Time frame: 3 months
3 secondary outcomes
Functional balance (Berg Balance Scale)
Time frame: by the time of discharge mean 2 weeks after admission and after 3 months
Functional mobility
Time frame: by the time of discharge mean 2 weeks after admission, and after 3 months
Functional strength
Time frame: by the time of discharge mean 2 weeks after admission and after 3 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 Nov 2010.
Related trials for Health-Related Quality of Life
Active, not recruitingObservational study
An Observational Study of Participants With Type 3 Von Willebrand Disease on Prophylactic Standard-of-Care Treatment
Von Willebrand Disease, Type 3
Not yet recruiting
Pilot Project on Enhancing Support for Hidden Elderly in the Three-nil Buildings and Old Tenement Buildings: Capacity Building & Impact Evaluation
3-nil Buildings Seniors
Recruiting
Multidisciplinary Non-Pharmacological Intervention to Improve Quality of Life in Solid Organ Transplant Recipients
Heart Transplant Patients, Kidney Transplant Patients
Active, not recruitingObservational study
A Prospective Longitudinal Study in Adults With Multifocal Motor Neuropathy
Multifocal Motor Neuropathy
Not yet recruiting
Manus AI-Assisted Orthodontic Education and Oral Health-Related Quality of Life
Oral Health-Related Quality of Life
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.
Astrid Bergland, Professor study chair
No afflication
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Balance- training and home-exercise and Balance-training and home-exercise in people with Health-Related 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 3 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: finished, as of the sponsor's last update on 24 Nov 2010. 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 (time frame: by the time of discharge mean 2 weeks after admission). The study lists 2 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 24 Nov 2010.