Effect of Activities and Exercise on Sleep in Elderly Persons With Dementia
|ClinicalTrials.gov Identifier: NCT00888706|
Recruitment Status : Completed
First Posted : April 28, 2009
Last Update Posted : April 28, 2009
|Condition or disease||Intervention/treatment||Phase|
|Dementia Elderly Sleep||Behavioral: Control Condition Behavioral: Individualized Social Activities (ISA) Behavioral: Physical Resistance Training and Walking (PRT/walking) Behavioral: Combined ISA/PRT/walking||Phase 2|
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 Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||355 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Outcomes Assessor)|
|Primary Purpose:||Supportive Care|
|Official Title:||Effect of Activities and Exercise on Sleep in Dementia|
|Study Start Date :||August 2002|
|Actual Primary Completion Date :||April 2008|
|Actual Study Completion Date :||April 2008|
|Active Comparator: 1||
Behavioral: Control Condition
The group participated in the usual nursing home activities and routines.
|Active Comparator: 2||
Behavioral: 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.
|Active Comparator: 3||
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.
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.
- Total sleep time at night and amplitude of the sleep wake rhythm. [ Time Frame: 7 weeks ]
- 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 ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00888706
|United States, Arkansas|
|Little Rock, Arkansas, United States|