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

Phase 2

Completed

• Conditions: Sleep; Elderly; Dementia
• Interventions: Behavioral: Control Condition; Behavioral: Individualized Social Activities (ISA); Behavioral: Combined ISA/PRT/walking; Behavioral: Physical Resistance Training and Walking (PRT/walking)

• Registration Number: NCT00888706
• Lead Sponsor: National Institute of Nursing Research (NINR)

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.

Study Timeline

• Study Start: 2002-08
• Primary Completion: 2008-04
• Study Completion: 2008-04
• Status Verified: 2009-04
• Study First Submitted: 2009-04-24
• Study First Submitted QC: 2009-04-27
• Last Update Submitted: 2009-04-27
• Study First Posted: 2009-04-28
• Last Update Posted: 2009-04-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 355

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	Control Condition	-
2	Individualized Social Activities (ISA)	-
4	Combined ISA/PRT/walking	-
3	Physical Resistance Training and Walking (PRT/walking)	-

Primary Outcome Measures

Name	Time	Method
Total sleep time at night and amplitude of the sleep wake rhythm.	7 weeks

Secondary Outcome Measures

Name	Time	Method
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