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

Effect of Activities and Exercise on Sleep in Dementia

Status
Completed
Phases
Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00888706
Enrollment
355
Registered
2009-04-28
Start date
2002-08-31
Completion date
2008-04-30
Last updated
2009-04-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Dementia, Elderly, Sleep

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.

Interventions

BEHAVIORALControl Condition

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

BEHAVIORALIndividualized 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.

BEHAVIORALPhysical 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.

BEHAVIORALCombined 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.

Sponsors

National Institute of Nursing Research (NINR)
Lead SponsorNIH

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
55 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
Total sleep time at night and amplitude of the sleep wake rhythm.7 weeks

Secondary

MeasureTime frame
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

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 8, 2026