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

Study Overview
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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.

Official Title
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Effect of Activities and Exercise on Sleep in Dementia

Conditions
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Dementia, Elderly, Sleep

Intervention / Treatment
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* Behavioral: Control Condition
* Behavioral: Individualized Social Activities (ISA)
* Behavioral: Physical Resistance Training and Walking (PRT/walking)
* Behavioral: Combined ISA/PRT/walking


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 55 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 1<br> | Behavioral: Control Condition<br>* The group participated in the usual nursing home activities and routines.<br>|
| Active Comparator: 2<br> | Behavioral: Individualized Social Activities (ISA)<br>* 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.<br>|
| Active Comparator: 3<br> | Behavioral: Physical Resistance Training and Walking (PRT/walking)<br>* 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.<br>|
| Experimental: 4<br> | Behavioral: Combined ISA/PRT/walking<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Total sleep time at night and amplitude of the sleep wake rhythm. |  | 7 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 |