DementiaEXDEMNCT02262104
Effects of an Exercise Program for Nursing Home Patients With Dementia
A study testing Intensive exercise in people with Dementia, run by Oslo Metropolitan University at 1 site in Norway.
Trial summary
The purpose of this study is to investigate the effect of an exercise program on nursing home patients with dementia. Read more about this study
- Who is it for?
- Ages 55 years and older
- Conditions the study is for
- Dementia
- What is being tested?
- Intensive exercise
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 170 participants
- Where
- 1 siteNorway
- Study dates
- Sep 2012to Sep 2013
- 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 55 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- >55 years old
- Living in nursing home
- Able to stand with help from max 1
- Able to walk 6 meters with or without walking aid
Who cannot join
- Medically unstable
- Longterm psychotic
- Severe communication problems
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of an Exercise Program for Nursing Home Patients With Dementia - a Six Months Assessor Blind Randomized Controlled Trial
The purpose of this study is to investigate the effect of an exercise program on nursing home patients with dementia.
Read the detailed description
The intervention group will be exercising one hour twice a week for 12 weeks. The participants will be doing intensive strength exercises and challenging balance exercises in groups of 4-6. Two physical therapists will be leading the intervention group. The control group will be meeting at the same frequency. Groups of 4-6 will be lead by an occupational therapist. The participants will be doing relaxation exercises, listen to music and social activities such as board games or indoor bowling.
The investigators will carry out three test periods:
- Baseline testing before intervention start
- Post test after 12 weeks of intervention
- Follow-up 12 weeks after post test.
The testing will comprise:
- Physical tests carried out by physiotherapists
- Questionnaires concerning mental health and ADL (activities of daily living)
- Cognition tests
- Cortisol in saliva
- Conditions
- Dementia
- Being tested
- Intensive exercise, Control
- Keywords
- Exercise, dementia, nursing home
- Medical subject headings
- Dementia, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intensive exerciseBehavioural
Arm 1: Intervention group. Intensive strength exercise (12RM) for lower limb and balance exercises twice a week for 1 hour. Groups of max 3 participants lead by physiotherapist
ControlBehavioural
Arm 2: control. Social activity group with light exercise, reading, and games. Lead by occupational therapist or nursing staff
| Study group | Role | What they receive |
|---|---|---|
| Intensive exercise | Experimental | Intensive strengthening and balance exercises 1 hour twice a week 12 weeks. Lead by physiotherapists. Receives: Behavioral: Intensive exercise |
| Control | Placebo comparator | Control group activities: Social activities one hour twice a week. Light physical activities, reading, conversation, games. Lead by occupational therapist or nursing staff Receives: Behavioral: Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Berg Balance Scale
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Oct 2014 (estimated)
- Study startSep 2012
- Primary completionSep 2013
- Study completionSep 2013
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 DementiaStudies 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
- 170 participants (actual)
Sponsor and investigators
- Lead sponsor
- Oslo Metropolitan University
- Sponsor type
- University, hospital or other
- Collaborators
- Norwegian Centre for Ageing and Health, University of Oslo
- Responsible party
- Principal investigator, Elisabeth Wiken Telenius, Oslo Metropolitan University
- Investigators
- Astrid Bergland, Principal investigator, Oslo and Akershus University college of Applied science
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02262104
- Sponsor's protocol ID
- REK 2012-1150
- Acronym
- EXDEM
- Status last verified
- Dec 2014
- First submitted
- 23 Nov 2013
- Last updated
- 3 Dec 2014
- Results posted
- No
- Data monitoring committee
- No
Publications
Kvael LAH, Bergland A, Telenius EW. Associations between physical function and depression in nursing home residents with mild and moderate dementia: a cross-sectional study. BMJ Open. 2017 Jul 20;7(7):e016875. doi: 10.1136/bmjopen-2017-016875.
PubMed 28729326Telenius EW, Engedal K, Bergland A. Long-term effects of a 12 weeks high-intensity functional exercise program on physical function and mental health in nursing home residents with dementia: a single blinded randomized controlled trial. BMC Geriatr. 2015 Dec 3;15:158. doi: 10.1186/s12877-015-0151-8.
PubMed 26630910Telenius EW, Engedal K, Bergland A. Effect of a high-intensity exercise program on physical function and mental health in nursing home residents with dementia: an assessor blinded randomized controlled trial. PLoS One. 2015 May 14;10(5):e0126102. doi: 10.1371/journal.pone.0126102. eCollection 2015.
PubMed 25974049
Study at a glance
From the registry record, last updated by the sponsor on 3 Dec 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of an Exercise Program for Nursing Home Patients With Dementia - a Six Months Assessor Blind Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT02262104
- Acronym / sponsor ID
- EXDEM / REK 2012-1150
- Conditions
- Dementia
- Keywords
- Exercise, dementia, nursing home
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 170 participants (actual)
- Lead sponsor
- Oslo Metropolitan UniversityUniversity, hospital or other
- Collaborators
- Norwegian Centre for Ageing and Health, University of Oslo
- Study start
- Sep 2012
- Primary completion
- Sep 2013 (actual)
- Study completion
- Sep 2013 (actual)
- First posted
- 10 Oct 2014 (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 investigate the effect of an exercise program on nursing home patients with dementia.
Detailed description
The intervention group will be exercising one hour twice a week for 12 weeks. The participants will be doing intensive strength exercises and challenging balance exercises in groups of 4-6. Two physical therapists will be leading the intervention group. The control group will be meeting at the same frequency. Groups of 4-6 will be lead by an occupational therapist. The participants will be doing relaxation exercises, listen to music and social activities such as board games or indoor bowling.
The investigators will carry out three test periods:
- Baseline testing before intervention start
- Post test after 12 weeks of intervention
- Follow-up 12 weeks after post test.
The testing will comprise:
- Physical tests carried out by physiotherapists
- Questionnaires concerning mental health and ADL (activities of daily living)
- Cognition tests
- Cortisol in saliva
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intensive exercise | Experimental | Behavioral: Intensive exerciseIntensive strengthening and balance exercises 1 hour twice a week 12 weeks. Lead by physiotherapists. |
| Control | Placebo comparator | Behavioral: ControlControl group activities: Social activities one hour twice a week. Light physical activities, reading, conversation, games. Lead by occupational therapist or nursing staff |
Who may qualify
- Ages
- 55 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- >55 years old
- Living in nursing home
- Able to stand with help from max 1
- Able to walk 6 meters with or without walking aid
Key exclusion criteria (3 listed)
- Medically unstable
- Longterm psychotic
- Severe communication problems
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 |
|---|---|---|
| Intensive exerciseArm 1: Intervention group. Intensive strength exercise (12RM) for lower limb and balance exercises twice a week for 1 hour. Groups of max 3 participants lead by physiotherapist | Behavioural | Intensive exercise |
| ControlArm 2: control. Social activity group with light exercise, reading, and games. Lead by occupational therapist or nursing staff | Behavioural | Control |
Primary outcome
Berg Balance Scale
Time frame: 12 weeks
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 3 Dec 2014.
- Derived from this study: PubMed 28729326Kvael LAH, Bergland A, Telenius EW. Associations between physical function and depression in nursing home residents with mild and moderate dementia: a cross-sectional study. BMJ Open. 2017 Jul 20;7(7):e016875. doi: 10.1136/bmjopen-2017-016875.
- Derived from this study: PubMed 26630910Telenius EW, Engedal K, Bergland A. Long-term effects of a 12 weeks high-intensity functional exercise program on physical function and mental health in nursing home residents with dementia: a single blinded randomized controlled trial. BMC Geriatr. 2015 Dec 3;15:158. doi: 10.1186/s12877-015-0151-8.
- Derived from this study: PubMed 25974049Telenius EW, Engedal K, Bergland A. Effect of a high-intensity exercise program on physical function and mental health in nursing home residents with dementia: an assessor blinded randomized controlled trial. PLoS One. 2015 May 14;10(5):e0126102. doi: 10.1371/journal.pone.0126102. eCollection 2015.
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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.
Astrid Bergland principal investigator
Oslo and Akershus University college of Applied science
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Intensive exercise in people with Dementia, run by Oslo Metropolitan University 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 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 3 Dec 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. Some participants in this study may receive a placebo. 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?
Berg Balance Scale (time frame: 12 weeks). 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 NCT02262104, 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 3 Dec 2014.