Effect of Activities and Exercise on Sleep in Elderly Persons With Dementia
| Tracking Information | |
|---|---|
| First Received Date ICMJE | April 24, 2009 |
| Last Updated Date | April 27, 2009 |
| Start Date ICMJE | August 2002 |
| Primary Completion Date | April 2008 (final data collection date for primary outcome measure) |
| Current Primary Outcome Measures ICMJE |
Total sleep time at night and amplitude of the sleep wake rhythm. [ Time Frame: 7 weeks ] [ Designated as safety issue: No ] |
| Original Primary Outcome Measures ICMJE | Same as current |
| Change History | Complete list of historical versions of study NCT00888706 on ClinicalTrials.gov Archive Site |
| Current Secondary Outcome Measures ICMJE |
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 ] [ Designated as safety issue: No ] |
| Original Secondary Outcome Measures ICMJE | Same as current |
| Current Other Outcome Measures ICMJE | Not Provided |
| Original Other Outcome Measures ICMJE | Not Provided |
| Descriptive Information | |
| Brief Title ICMJE | Effect of Activities and Exercise on Sleep in Elderly Persons With Dementia |
| Official Title ICMJE | Effect of Activities and Exercise on Sleep in Dementia |
| 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 Type ICMJE | Interventional |
| Study Phase | Phase 2 |
| Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Single Blind (Outcomes Assessor) Primary Purpose: Supportive Care |
| Condition ICMJE |
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| Intervention ICMJE |
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| Study Arm (s) |
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| Publications * |
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |
| Recruitment Status ICMJE | Completed |
| Enrollment ICMJE | 355 |
| Completion Date | April 2008 |
| Primary Completion Date | April 2008 (final data collection date for primary outcome measure) |
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both |
| Ages | 55 Years and older |
| Accepts Healthy Volunteers | No |
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects |
| Location Countries ICMJE | United States |
| Administrative Information | |
| NCT Number ICMJE | NCT00888706 |
| Other Study ID Numbers ICMJE | R01NR007771, R01 NR007771 |
| Has Data Monitoring Committee | Yes |
| Responsible Party | Dr. Kathy C. Richards, Polisher Research Institute; Abramson Center for Jewish Life |
| Study Sponsor ICMJE | National Institute of Nursing Research (NINR) |
| Collaborators ICMJE | Not Provided |
| Investigators ICMJE | Not Provided |
| Information Provided By | National Institute of Nursing Research (NINR) |
| Verification Date | April 2009 |
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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