Completed

Effect of Activities and Exercise on Sleep in Dementia

What is being tested

Control Condition

+ Individualized Social Activities (ISA)

+ Physical Resistance Training and Walking (PRT/walking)

Behavioral

Who is being recruted

Mental Disorders+3

+ Brain Diseases

+ Central Nervous System Diseases

Over 55 Years

+10 Eligibility Criteria

See all eligibility criteria

How is the trial designed

Supportive Care Study

Phase 2

Interventional

Study Start: August 2002

See protocol details

Summary

Principal SponsorNational Institute of Nursing Research (NINR)

Last updated: January 27, 2026

Sourced from a government-validated database.Claim as a partner

Study start date: August 1, 2002

Actual date on which the first participant was enrolled.

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.

Official TitleEffect of Activities and Exercise on Sleep in Dementia

NCT00888706

Principal SponsorNational Institute of Nursing Research (NINR)

Last updated: January 27, 2026

Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Design Details

355 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Supportive Care Study

These studies explore ways to improve comfort and daily life for people living with a condition. They may focus on easing symptoms, reducing treatment side effects, or supporting overall well-being.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.

Conditions

Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Over 55 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Mental DisordersBrain DiseasesCentral Nervous System DiseasesDementiaNervous System DiseasesNeurocognitive Disorders

Criteria

6 inclusion criteria required to participate

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

Show More Criteria

4 exclusion criteria prevent from participating

Treatment with chemotherapy; AND

Unstable cardiovascular disease

Documented near-terminal or unstable medical conditions

Unresolved malignancy

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.

Treatment Groups

Study Objectives

4 intervention groups are designated in this study

This study does not include a placebo group

Treatment Groups

Group I

Active Comparator

Group II

Active Comparator

Group III

Active Comparator

Group IV

Experimental

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has no location dataSave this study to your profile to know when the location data is available.

CompletedNo study centers