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

Primary Purpose

Dementia, Elderly, Sleep

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Control Condition
Individualized Social Activities (ISA)
Physical Resistance Training and Walking (PRT/walking)
Combined ISA/PRT/walking
Sponsored by
National Institute of Nursing Research (NINR)
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Dementia

Eligibility Criteria

55 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Active Comparator

Active Comparator

Active Comparator

Experimental

Arm Label

1

2

3

4

Arm Description

Outcomes

Primary Outcome Measures

Total sleep time at night and amplitude of the sleep wake rhythm.

Secondary Outcome Measures

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.

Full Information

First Posted
April 24, 2009
Last Updated
April 27, 2009
Sponsor
National Institute of Nursing Research (NINR)
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1. Study Identification

Unique Protocol Identification Number
NCT00888706
Brief Title
Effect of Activities and Exercise on Sleep in Elderly Persons With Dementia
Official Title
Effect of Activities and Exercise on Sleep in Dementia
Study Type
Interventional

2. Study Status

Record Verification Date
April 2009
Overall Recruitment Status
Completed
Study Start Date
August 2002 (undefined)
Primary Completion Date
April 2008 (Actual)
Study Completion Date
April 2008 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
National Institute of Nursing Research (NINR)

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dementia, Elderly, Sleep

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
355 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Active Comparator
Arm Title
2
Arm Type
Active Comparator
Arm Title
3
Arm Type
Active Comparator
Arm Title
4
Arm Type
Experimental
Intervention Type
Behavioral
Intervention Name(s)
Control Condition
Intervention Description
The group participated in the usual nursing home activities and routines.
Intervention Type
Behavioral
Intervention Name(s)
Individualized Social Activities (ISA)
Intervention Description
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
Intervention Name(s)
Physical Resistance Training and Walking (PRT/walking)
Intervention Description
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
Intervention Name(s)
Combined ISA/PRT/walking
Intervention Description
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.
Primary Outcome Measure Information:
Title
Total sleep time at night and amplitude of the sleep wake rhythm.
Time Frame
7 weeks
Secondary Outcome Measure Information:
Title
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
City
Little Rock
State/Province
Arkansas
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
20043249
Citation
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.
Results Reference
background
PubMed Identifier
18274270
Citation
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.
Results Reference
background
PubMed Identifier
28795452
Citation
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.
Results Reference
derived
PubMed Identifier
25294621
Citation
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.
Results Reference
derived
PubMed Identifier
22617163
Citation
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.
Results Reference
derived
PubMed Identifier
21314643
Citation
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.
Results Reference
derived

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

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