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

This study has been completed.
Sponsor:
Information provided by:
National Institute of Nursing Research (NINR)
ClinicalTrials.gov Identifier:
NCT00888706
First received: April 24, 2009
Last updated: April 27, 2009
Last verified: April 2009

April 24, 2009
April 27, 2009
August 2002
April 2008   (final data collection date for primary outcome measure)
Total sleep time at night and amplitude of the sleep wake rhythm. [ Time Frame: 7 weeks ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00888706 on ClinicalTrials.gov Archive Site
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 ]
Same as current
Not Provided
Not Provided
 
Effect of Activities and Exercise on Sleep in Elderly Persons With Dementia
Effect of Activities and Exercise on Sleep in Dementia

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.

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.

Interventional
Phase 2
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Supportive Care
  • Dementia
  • Elderly
  • Sleep
  • Behavioral: Control Condition
    The group participated in the usual nursing home activities and routines.
  • 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.
  • 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.
  • Active Comparator: 1
    Intervention: Behavioral: Control Condition
  • Active Comparator: 2
    Intervention: Behavioral: Individualized Social Activities (ISA)
  • Active Comparator: 3
    Intervention: Behavioral: Physical Resistance Training and Walking (PRT/walking)
  • Experimental: 4
    Intervention: Behavioral: Combined ISA/PRT/walking

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
355
April 2008
April 2008   (final data collection date for primary outcome measure)

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
Both
55 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00888706
R01NR007771, R01 NR007771
Yes
Dr. Kathy C. Richards, Polisher Research Institute; Abramson Center for Jewish Life
National Institute of Nursing Research (NINR)
Not Provided
Not Provided
National Institute of Nursing Research (NINR)
April 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP