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

National Institutes of Health (NIH)

Status and phase: Completed; Phase 2

Conditions: Elderly; Dementia; Sleep

Treatments: Behavioral: Control Condition; Behavioral: Physical Resistance Training and Walking (PRT/walking); Behavioral: Combined ISA/PRT/walking; Behavioral: Individualized Social Activities (ISA)

Study type: Interventional

Funder types: NIH

Identifiers

NCT00888706

R01NR007771 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 355 patients

Sex: All

Ages: 55+ years old

Volunteers: No 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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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355 participants in 4 patient groups

1

Active Comparator group

Treatment:

Behavioral: Control Condition

2

Active Comparator group

Treatment:

Behavioral: Individualized Social Activities (ISA)

3

Active Comparator group

Treatment:

Behavioral: Physical Resistance Training and Walking (PRT/walking)

4

Experimental group

Treatment:

Behavioral: Combined ISA/PRT/walking