DementiaPhase 2NCT00888706
Effect of Activities and Exercise on Sleep in Elderly Persons With Dementia
A Phase 2 study testing Individualized Social Activities (ISA), Physical Resistance Training and Walking (PRT/walking) and Combined ISA/PRT/walking in people with Dementia and Elderly, run by National Institute of Nursing Research (NINR) at 1 site in United States.
Trial summary
The purpose of the study is to determine whether individualized social activities, physical resistance training and walking, and a combination of both are effective in improving nighttime sleep in elders with dementia. Read more about this study
- Who is it for?
- Ages 55 years and older
- What is being tested?
- Individualized Social Activities (ISA), Physical Resistance Training and Walking (PRT/walking) and Combined ISA/PRT/walking
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 355 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2002to Apr 2008
- 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 55 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 55 years old or older
- Mini Mental State Examination (MMSE)of 4-26, indicating dementia or mild cognitive impairment
- Less than seven hours of nocturnal sleep and 30 minutes of daytime sleep
- At least two weeks residency in the nursing home
- Medical diagnosis of dementia; AND
- Ability to stand with assistance
Who cannot join
- Documented near-terminal or unstable medical conditions
- Unresolved malignancy
- Treatment with chemotherapy; AND
- Unstable cardiovascular disease
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Activities and Exercise on Sleep in Dementia
The purpose of the study is to determine whether individualized social activities, physical resistance training and walking, and a combination of both are effective in improving nighttime sleep in elders with dementia.
Read the detailed description
Elders with cognitive impairment usually do not a get a good night's sleep and wake up often during their sleep at night. Increased daytime individualized social activity and physical resistance training with walking have the potential to increase nighttime sleep in elders. This can lead to a better quality of life, a decrease in caregiver burden and decrease in nighttime falls for this population and associated fiscal savings.
Consent forms for this RCT, were written in large print, followed all the guidelines of the Institutional Review Board of the University of Arkansas for Medical Sciences, and assured the participants that their participation in the study was voluntary.
- Being tested
- Control Condition, Individualized Social Activities (ISA), Physical Resistance Training and Walking (PRT/walking), Combined ISA/PRT/walking
- Medical subject headings
- Dementia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Control ConditionBehavioural
The group participated in the usual nursing home activities and routines.
Individualized Social Activities (ISA)Behavioural
The group received individualized social activities one hour daily, during usual brief daytime napping episodes, between 9 am to 5 pm in brief 15-30 minute intervals five days a week.
Physical Resistance Training and Walking (PRT/walking)Behavioural
The group participated in high intensity PRT to the hip and arm extensors (three sets of eight repetitions per muscle per group, approximately 40 minutes) plus 10 minutes of warm-up and 10 minutes of cool-down on Monday, Wednesday and Friday afternoons for one hour (between 2-5pm). On Tuesdays and Thursdays, participants walked with a research assistant for as long as the participant could walk for up to 60 minutes.
Combined ISA/PRT/walkingBehavioural
The group had one hour of ISA in the morning or afternoon and one hour of PRT/walking in the afternoon from 2-5pm five days a week. This group received interventions for 2 hours per day.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | Not described Receives: Behavioral: Control Condition |
| 2 | Active comparator | Not described Receives: Behavioral: Individualized Social Activities (ISA) |
| 3 | Active comparator | Not described Receives: Behavioral: Physical Resistance Training and Walking (PRT/walking) |
| 4 | Experimental | Not described Receives: Behavioral: Combined ISA/PRT/walking |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total sleep time at night and amplitude of the sleep wake rhythm.
Measured: 7 weeks
Secondary outcomes (1)
To explore the roles of daytime napping, muscle strength, and physical activity for mediating the effect of Physical Resistance Training (PRT) and walking on total sleep time at night.
Measured: 7 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Apr 2009 (estimated)
- Study startAug 2002
- Primary completionApr 2008
- Study completionApr 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)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 2
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 355 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Institute of Nursing Research (NINR)
- Sponsor type
- US National Institutes of Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00888706
- Sponsor's protocol ID
- R01NR007771
- Other IDs
- R01NR007771
- Status last verified
- Apr 2009
- First submitted
- 24 Apr 2009
- Last updated
- 28 Apr 2009
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Richards K, Shue VM, Beck CK, Lambert CW, Bliwise DL. Restless legs syndrome risk factors, behaviors, and diagnoses in persons with early to moderate dementia and sleep disturbance. Behav Sleep Med. 2010;8(1):48-61. doi: 10.1080/15402000903425769.
PubMed 20043249Richards KC, Roberson PK, Simpson K, Lambert CW, Bliwise DL, Cole CS, Enderlin C, Shue VM, Siddiqui N, Williams JS. Periodic leg movements predict total sleep time in persons with cognitive impairment and sleep disturbance. Sleep. 2008 Feb;31(2):224-30. doi: 10.1093/sleep/31.2.224.
PubMed 18274270Herrick JE, Puri S, Richards KC. Resistance training does not alter same-day sleep architecture in institutionalized older adults. J Sleep Res. 2018 Aug;27(4):e12590. doi: 10.1111/jsr.12590. Epub 2017 Aug 10.
PubMed 28795452Herrick JE, Bliwise DL, Puri S, Rogers S, Richards KC. Strength training and light physical activity reduces the apnea-hypopnea index in institutionalized older adults. J Am Med Dir Assoc. 2014;15(11):844-6. doi: 10.1016/j.jamda.2014.08.006. Epub 2014 Oct 5.
PubMed 25294621Lorenz RA, Gooneratne N, Cole CS, Kleban MH, Kalra GK, Richards KC. Exercise and social activity improve everyday function in long-term care residents. Am J Geriatr Psychiatry. 2012 Jun;20(6):468-76. doi: 10.1097/JGP.0b013e318246b807.
PubMed 22617163Richards KC, Lambert C, Beck CK, Bliwise DL, Evans WJ, Kalra GK, Kleban MH, Lorenz R, Rose K, Gooneratne NS, Sullivan DH. Strength training, walking, and social activity improve sleep in nursing home and assisted living residents: randomized controlled trial. J Am Geriatr Soc. 2011 Feb;59(2):214-23. doi: 10.1111/j.1532-5415.2010.03246.x.
PubMed 21314643
Study at a glance
From the registry record, last updated by the sponsor on 28 Apr 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Activities and Exercise on Sleep in Dementia
- ClinicalTrials.gov ID
- NCT00888706
- Acronym / sponsor ID
- R01NR007771
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 355 participants (actual)
- Lead sponsor
- National Institute of Nursing Research (NINR)US National Institutes of Health
- Study start
- Aug 2002
- Primary completion
- Apr 2008 (actual)
- Study completion
- Apr 2008 (actual)
- First posted
- 28 Apr 2009 (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 the study is to determine whether individualized social activities, physical resistance training and walking, and a combination of both are effective in improving nighttime sleep in elders with dementia.
Detailed description
Elders with cognitive impairment usually do not a get a good night's sleep and wake up often during their sleep at night. Increased daytime individualized social activity and physical resistance training with walking have the potential to increase nighttime sleep in elders. This can lead to a better quality of life, a decrease in caregiver burden and decrease in nighttime falls for this population and associated fiscal savings.
Consent forms for this RCT, were written in large print, followed all the guidelines of the Institutional Review Board of the University of Arkansas for Medical Sciences, and assured the participants that their participation in the study was voluntary.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Behavioral: Control Condition |
| 2 | Active comparator | Behavioral: Individualized Social Activities (ISA) |
| 3 | Active comparator | Behavioral: Physical Resistance Training and Walking (PRT/walking) |
| 4 | Experimental | Behavioral: Combined ISA/PRT/walking |
Who may qualify
- Ages
- 55 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Age 55 years old or older
- Mini Mental State Examination (MMSE)of 4-26, indicating dementia or mild cognitive impairment
- Less than seven hours of nocturnal sleep and 30 minutes of daytime sleep
- At least two weeks residency in the nursing home
- Medical diagnosis of dementia; AND
Key exclusion criteria (4 listed)
- Documented near-terminal or unstable medical conditions
- Unresolved malignancy
- Treatment with chemotherapy; AND
- Unstable cardiovascular 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 |
|---|---|---|
| Control ConditionThe group participated in the usual nursing home activities and routines. | Behavioural | 1 |
| Individualized Social Activities (ISA)The group received individualized social activities one hour daily, during usual brief daytime napping episodes, between 9 am to 5 pm in brief 15-30 minute intervals five days a week. | Behavioural | 2 |
| Physical Resistance Training and Walking (PRT/walking)The group participated in high intensity PRT to the hip and arm extensors (three sets of eight repetitions per muscle per group, approximately 40 minutes) plus 10 minutes of warm-up and 10 minutes of cool-down on Monday, Wednesday and Friday afternoons for one hour (between 2-5pm). On Tuesdays and Thursdays, participants walked with a research assistant for as long as the participant could walk for up to 60 minutes. | Behavioural | 3 |
| Combined ISA/PRT/walkingThe group had one hour of ISA in the morning or afternoon and one hour of PRT/walking in the afternoon from 2-5pm five days a week. This group received interventions for 2 hours per day. | Behavioural | 4 |
Primary outcome
Total sleep time at night and amplitude of the sleep wake rhythm.
Time frame: 7 weeks
1 secondary outcome
To explore the roles of daytime napping, muscle strength, and physical activity for mediating the effect of Physical Resistance Training (PRT) and walking on total sleep time at night.
Time frame: 7 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 28 Apr 2009.
- Background: PubMed 20043249Richards K, Shue VM, Beck CK, Lambert CW, Bliwise DL. Restless legs syndrome risk factors, behaviors, and diagnoses in persons with early to moderate dementia and sleep disturbance. Behav Sleep Med. 2010;8(1):48-61. doi: 10.1080/15402000903425769.
- Background: PubMed 18274270Richards KC, Roberson PK, Simpson K, Lambert CW, Bliwise DL, Cole CS, Enderlin C, Shue VM, Siddiqui N, Williams JS. Periodic leg movements predict total sleep time in persons with cognitive impairment and sleep disturbance. Sleep. 2008 Feb;31(2):224-30. doi: 10.1093/sleep/31.2.224.
- Derived from this study: PubMed 28795452Herrick JE, Puri S, Richards KC. Resistance training does not alter same-day sleep architecture in institutionalized older adults. J Sleep Res. 2018 Aug;27(4):e12590. doi: 10.1111/jsr.12590. Epub 2017 Aug 10.
- Derived from this study: PubMed 25294621Herrick JE, Bliwise DL, Puri S, Rogers S, Richards KC. Strength training and light physical activity reduces the apnea-hypopnea index in institutionalized older adults. J Am Med Dir Assoc. 2014;15(11):844-6. doi: 10.1016/j.jamda.2014.08.006. Epub 2014 Oct 5.
- Derived from this study: PubMed 22617163Lorenz RA, Gooneratne N, Cole CS, Kleban MH, Kalra GK, Richards KC. Exercise and social activity improve everyday function in long-term care residents. Am J Geriatr Psychiatry. 2012 Jun;20(6):468-76. doi: 10.1097/JGP.0b013e318246b807.
- Derived from this study: PubMed 21314643Richards KC, Lambert C, Beck CK, Bliwise DL, Evans WJ, Kalra GK, Kleban MH, Lorenz R, Rose K, Gooneratne NS, Sullivan DH. Strength training, walking, and social activity improve sleep in nursing home and assisted living residents: randomized controlled trial. J Am Geriatr Soc. 2011 Feb;59(2):214-23. doi: 10.1111/j.1532-5415.2010.03246.x.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Individualized Social Activities (ISA), Physical Resistance Training and Walking (PRT/walking) and Combined ISA/PRT/walking in people with Dementia and Elderly, run by National Institute of Nursing Research (NINR) at 1 site in United States.
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 6 inclusion and 4 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 28 Apr 2009. 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 United States. 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?
Total sleep time at night and amplitude of the sleep wake rhythm. (time frame: 7 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 NCT00888706, which also lists 6 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 28 Apr 2009.