Effect of Activities and Exercise on Sleep in Elderly Persons With Dementia

NCT ID: NCT00888706

Last Updated: 2009-04-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

355 participants

Study Classification

INTERVENTIONAL

Study Start Date

2002-08-31

Study Completion Date

2008-04-30

Brief Summary

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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

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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.

Conditions

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Dementia Elderly Sleep

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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1

Group Type ACTIVE_COMPARATOR

Control Condition

Intervention Type BEHAVIORAL

The group participated in the usual nursing home activities and routines.

2

Group Type ACTIVE_COMPARATOR

Individualized Social Activities (ISA)

Intervention Type BEHAVIORAL

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.

3

Group Type ACTIVE_COMPARATOR

Physical Resistance Training and Walking (PRT/walking)

Intervention Type BEHAVIORAL

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.

4

Group Type EXPERIMENTAL

Combined ISA/PRT/walking

Intervention Type BEHAVIORAL

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.

Interventions

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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.

Intervention Type BEHAVIORAL

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.

Intervention Type BEHAVIORAL

Combined ISA/PRT/walking

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.

Intervention Type BEHAVIORAL

Control Condition

The group participated in the usual nursing home activities and routines.

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* 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

Exclusion Criteria

* Documented near-terminal or unstable medical conditions
* Unresolved malignancy
* Treatment with chemotherapy; AND
* Unstable cardiovascular disease
Minimum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Institute of Nursing Research (NINR)

NIH

Sponsor Role lead

Responsible Party

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Polisher Research Institute; Abramson Center for Jewish Life

Locations

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Little Rock, Arkansas, United States

Site Status

Countries

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United States

References

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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.

Reference Type BACKGROUND
PMID: 20043249 (View on PubMed)

Richards 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.

Reference Type BACKGROUND
PMID: 18274270 (View on PubMed)

Herrick 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.

Reference Type DERIVED
PMID: 28795452 (View on PubMed)

Herrick 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.

Reference Type DERIVED
PMID: 25294621 (View on PubMed)

Lorenz 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.

Reference Type DERIVED
PMID: 22617163 (View on PubMed)

Richards 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.

Reference Type DERIVED
PMID: 21314643 (View on PubMed)

Other Identifiers

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R01NR007771

Identifier Type: NIH

Identifier Source: secondary_id

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R01NR007771

Identifier Type: NIH

Identifier Source: org_study_id

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