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

Dementia Clinical Trial

Official title:

Effect of Activities and Exercise on Sleep in Dementia

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00888706
• Other study ID #: R01NR007771
• Secondary ID: R01NR007771
• Status: Completed
• Phase: Phase 2
• First received: April 24, 2009
• Last updated: April 27, 2009
• Start date: August 2002
• Est. completion date: April 2008

Study information

• Verified date: April 2009
• Source: National Institute of Nursing Research (NINR)
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 355
• Est. completion date: April 2008
• Est. primary completion date: April 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 55 Years and older

Eligibility

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

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Dementia
• Elderly
• Sleep

Intervention

Behavioral:
• Control Condition
The group participated in the usual nursing home activities and routines.
• 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.
• 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.
• 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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
National Institute of Nursing Research (NINR)

Country where clinical trial is conducted

United States, 

References & Publications (2)

Richards K, Shue VM, Beck CK, Lambert CW, Bliwise DL. Restless legs syndrome risk factors, behaviors, and diagnoses in persons with early to moderate dementia and sleep disturbance. Behav Sleep Med. 2010;8(1):48-61. doi: 10.1080/15402000903425769. — View Citation

Richards KC, Roberson PK, Simpson K, Lambert CW, Bliwise DL, Cole CS, Enderlin C, Shue VM, Siddiqui N, Williams JS. Periodic leg movements predict total sleep time in persons with cognitive impairment and sleep disturbance. Sleep. 2008 Feb;31(2):224-30. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Total sleep time at night and amplitude of the sleep wake rhythm.		7 weeks	No
Secondary	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	No