FrailtyNCT00218842
The Effect on Function of Increasing Activity for Nursing Home Residents
A study testing Individualized exercise in people with Frailty and Nursing Home Residents, run by Norwegian University of Science and Technology at 1 site in Norway.
Trial summary
As designs of existing outcome studies are disparate and do not always relate well to a Swedish context, the need for further studies is obvious. Also, an empirical theory drawn from the best practice supporting autonomy and wellbeing for clients in a nursing home setting has not yet been fully depicted. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Frailty, Nursing Home Residents
- What is being tested?
- Individualized exercise
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 125 participants
- Where
- 1 siteNorway
- Study dates
- Oct 2005to Dec 2009
- 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 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- > 65 years of age
- Expected stay in the nursing home > 3 months
- Able to take instruction
Who cannot join
- Persons in a terminal phase
Trial locations and contacts
1 site in 1 country.
Norway1 site
Section of Geriatric Medicine, St. Olavs University Hospital
Trondheim, Trondheim, N-7016
About this study
Official title: Physical and Daily Activity for Residents in a Nursing Home Setting. -A Nordic Multi-Centre Study
As designs of existing outcome studies are disparate and do not always relate well to a Swedish context, the need for further studies is obvious. Also, an empirical theory drawn from the best practice supporting autonomy and wellbeing for clients in a nursing home setting has not yet been fully depicted. The study described below intends to fill a gap in knowledge related to the effect of enhanced activities of daily living (ADL)-training, physical, and daily activities and staff education in a nursing home setting, based on a theory- and evidence-based intervention programme in a Swedish as well as a Nordic health care context. The aims of the study are to describe the impact of an individually tailored intervention program, in a nursing home setting, on:
- Physical capacity
- Degree of dependence in ADL
- Long-term participation in physical and/or daily activities
- Self-rated wellbeing
Read the detailed description
The Trondheim study has additional aims to assess the impact of intervention on:
- Urinary incontinence
- Falls
- Conditions
- Frailty, Nursing Home Residents
- Being tested
- Individualized exercise
- Keywords
- exercise, functioning, frail elderly
- Medical subject headings
- Frailty, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Individualized exerciseBehavioural
individualized exercise, physical activity and training in daily life situations given by trained physical therapists and occupational therapists
| Study group | Role | What they receive |
|---|---|---|
| exercise group | Experimental | individualized exercise Receives: Behavioral: Individualized exercise |
| control group | No intervention | care as usal |
What is being measured
The primary outcome is the main question the study is designed to answer.
Physical function
Measured: baseline, three and six months
Secondary outcomes (1)
Falls
Measured: during six months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Sep 2005 (estimated)
- Study startOct 2005
- Primary completionOct 2009
- Study completionDec 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for FrailtyStudies 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
- 125 participants (actual)
Sponsor and investigators
- Lead sponsor
- Norwegian University of Science and Technology
- Sponsor type
- University, hospital or other
- Collaborators
- Helse Midt-Norge
- Responsible party
- Sponsor
- Investigators
- Jorunn L Helbostad, PhD, Study chair, St. Olavs University Hospital and Norwegian University of Science and Technology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00218842
- Sponsor's protocol ID
- 203-04
- Status last verified
- Mar 2014
- First submitted
- 20 Sep 2005
- Last updated
- 7 Mar 2014
- Results posted
- No
- Data monitoring committee
- No
Publications
Frandin K, Borell L, Gronstedt H, Bergland A, Helbostad JL, Puggaard L, Andresen M, Granbo R, Hellstrom K. A Nordic multi-center study on physical and daily activities for residents in nursing home settings: design of a randomized, controlled trial. Aging Clin Exp Res. 2009 Aug-Oct;21(4-5):314-22. doi: 10.1007/BF03324921.
PubMed 19959920Gronstedt H, Hellstrom K, Bergland A, Helbostad JL, Puggaard L, Andresen M, Granbo R, Frandin K. Functional level, physical activity and wellbeing in nursing home residents in three Nordic countries. Aging Clin Exp Res. 2011 Oct-Dec;23(5-6):413-20. doi: 10.1007/BF03337766. Epub 2011 Feb 10.
PubMed 21311211Gronstedt H, Frandin K, Bergland A, Helbostad JL, Granbo R, Puggaard L, Andresen M, Hellstrom K. Effects of individually tailored physical and daily activities in nursing home residents on activities of daily living, physical performance and physical activity level: a randomized controlled trial. Gerontology. 2013;59(3):220-9. doi: 10.1159/000345416. Epub 2012 Dec 20.
PubMed 23258191
Study at a glance
From the registry record, last updated by the sponsor on 7 Mar 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Physical and Daily Activity for Residents in a Nursing Home Setting. -A Nordic Multi-Centre Study
- ClinicalTrials.gov ID
- NCT00218842
- Acronym / sponsor ID
- 203-04
- Conditions
- Frailty, Nursing Home Residents
- Keywords
- exercise, functioning, frail elderly
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 125 participants (actual)
- Lead sponsor
- Norwegian University of Science and TechnologyUniversity, hospital or other
- Collaborators
- Helse Midt-Norge
- Study start
- Oct 2005
- Primary completion
- Oct 2009 (actual)
- Study completion
- Dec 2009 (actual)
- First posted
- 22 Sep 2005 (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.
As designs of existing outcome studies are disparate and do not always relate well to a Swedish context, the need for further studies is obvious. Also, an empirical theory drawn from the best practice supporting autonomy and wellbeing for clients in a nursing home setting has not yet been fully depicted. The study described below intends to fill a gap in knowledge related to the effect of enhanced activities of daily living (ADL)-training, physical, and daily activities and staff education in a nursing home setting, based on a theory- and evidence-based intervention programme in a Swedish as well as a Nordic health care context. The aims of the study are to describe the impact of an individually tailored intervention program, in a nursing home setting, on:
- Physical capacity
- Degree of dependence in ADL
- Long-term participation in physical and/or daily activities
- Self-rated wellbeing
Detailed description
The Trondheim study has additional aims to assess the impact of intervention on:
- Urinary incontinence
- Falls
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| exercise group | Experimental | Behavioral: Individualized exerciseindividualized exercise |
| control group | No intervention | –care as usal |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (3 listed)
- > 65 years of age
- Expected stay in the nursing home > 3 months
- Able to take instruction
Key exclusion criteria (1 listed)
- Persons in a terminal phase
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 |
|---|---|---|
| Individualized exerciseindividualized exercise, physical activity and training in daily life situations given by trained physical therapists and occupational therapists | Behavioural | exercise group |
Primary outcome
Physical function
Time frame: baseline, three and six months
1 secondary outcome
Falls
Time frame: during six 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 7 Mar 2014.
- Background: PubMed 19959920Frandin K, Borell L, Gronstedt H, Bergland A, Helbostad JL, Puggaard L, Andresen M, Granbo R, Hellstrom K. A Nordic multi-center study on physical and daily activities for residents in nursing home settings: design of a randomized, controlled trial. Aging Clin Exp Res. 2009 Aug-Oct;21(4-5):314-22. doi: 10.1007/BF03324921.
- Background: PubMed 21311211Gronstedt H, Hellstrom K, Bergland A, Helbostad JL, Puggaard L, Andresen M, Granbo R, Frandin K. Functional level, physical activity and wellbeing in nursing home residents in three Nordic countries. Aging Clin Exp Res. 2011 Oct-Dec;23(5-6):413-20. doi: 10.1007/BF03337766. Epub 2011 Feb 10.
- Results publication: PubMed 23258191Gronstedt H, Frandin K, Bergland A, Helbostad JL, Granbo R, Puggaard L, Andresen M, Hellstrom K. Effects of individually tailored physical and daily activities in nursing home residents on activities of daily living, physical performance and physical activity level: a randomized controlled trial. Gerontology. 2013;59(3):220-9. doi: 10.1159/000345416. Epub 2012 Dec 20.
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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.
Jorunn L Helbostad, PhD study chair
St. Olavs University Hospital and Norwegian University of Science and Technology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Individualized exercise in people with Frailty and Nursing Home Residents, run by Norwegian University of Science and Technology 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 7 Mar 2014. 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?
Physical function (time frame: baseline, three and six months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00218842, which also lists 3 linked publications.
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 7 Mar 2014.