Effect of Activities and Exercise on Sleep in Elderly Persons With Dementia
1 other identifier
interventional
355
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Aug 2002
Longer than P75 for phase_2
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 1, 2002
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2008
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2008
CompletedFirst Submitted
Initial submission to the registry
April 24, 2009
CompletedFirst Posted
Study publicly available on registry
April 28, 2009
CompletedApril 28, 2009
April 1, 2009
5.7 years
April 24, 2009
April 27, 2009
Conditions
Outcome Measures
Primary Outcomes (1)
Total sleep time at night and amplitude of the sleep wake rhythm.
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.
7 weeks
Study Arms (4)
1
ACTIVE COMPARATOR2
ACTIVE COMPARATOR3
ACTIVE COMPARATOR4
EXPERIMENTALInterventions
The group participated in the usual nursing home activities and routines.
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.
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.
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.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- Documented near-terminal or unstable medical conditions
- Unresolved malignancy
- Treatment with chemotherapy; AND
- Unstable cardiovascular disease
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Unknown Facility
Little Rock, Arkansas, United States
Related Publications (6)
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.
PMID: 20043249BACKGROUNDRichards 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.
PMID: 18274270BACKGROUNDHerrick 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.
PMID: 28795452DERIVEDHerrick 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.
PMID: 25294621DERIVEDLorenz 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.
PMID: 22617163DERIVEDRichards 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.
PMID: 21314643DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- NIH
Study Record Dates
First Submitted
April 24, 2009
First Posted
April 28, 2009
Study Start
August 1, 2002
Primary Completion
April 1, 2008
Study Completion
April 1, 2008
Last Updated
April 28, 2009
Record last verified: 2009-04