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Completed

NCT Number: NCT00888706

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

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Key information

Conditions

Dementia Brain Diseases Central Nervous System Diseases Elderly Mental Disorders Nervous System Diseases Neurocognitive Disorders Sleep

Age range

55 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Little Rock, Arkansas, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Control condition

Behavioral

The group participated in the usual nursing home activities and routines.

Individualized Social Activities (ISA)

Behavioral

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)

Behavioral

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

Behavioral

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.

Primary outcomes

  1. Total sleep time at night and amplitude of the sleep wake rhythm.

    Time frame: 7 weeks

Secondary outcomes

  1. 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

Sponsors and collaborators

Lead sponsor

National Institute of Nursing Research (NINR)

Nih

Registry information

Official study title

Effect of Activities and Exercise on Sleep in Dementia

Important dates

Study start
2002
Primary completion
2008
Study completion
2008
First posted
Apr 28, 2009
Registry last updated
Apr 28, 2009

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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