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
  Purpose

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.


Condition Intervention 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

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Supportive Care
Official Title: Effect of Activities and Exercise on Sleep in Dementia

Resource links provided by NLM:


Further study details as provided by National Institute of Nursing Research (NINR):

Primary Outcome Measures:
  • Total sleep time at night and amplitude of the sleep wake rhythm. [ Time Frame: 7 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 355
Study Start Date: August 2002
Study Completion Date: April 2008
Primary Completion Date: April 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
Experimental: 4 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.

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.

  Eligibility

Ages Eligible for Study:   55 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00888706

Locations
United States, Arkansas
Little Rock, Arkansas, United States
Sponsors and Collaborators
  More Information

Publications:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Dr. Kathy C. Richards, Polisher Research Institute; Abramson Center for Jewish Life
ClinicalTrials.gov Identifier: NCT00888706     History of Changes
Other Study ID Numbers: R01NR007771, R01 NR007771
Study First Received: April 24, 2009
Last Updated: April 27, 2009
Health Authority: United States: Federal Government

Additional relevant MeSH terms:
Dementia
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Delirium, Dementia, Amnestic, Cognitive Disorders
Mental Disorders

ClinicalTrials.gov processed this record on July 29, 2014