CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 355 enrolled
Drug / intervention
Control Condition +3 morebehavioral
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

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Search/NCT00888706
NCT00888706Phase 2Completed

Effect of Activities and Exercise on Sleep in Dementia

National Institute of Nursing Research (NINR)·interventional·Posted Apr 28, 2009·Updated Apr 28, 2009

In Brief

A Phase 2 clinical trial evaluating Control Condition, Individualized Social Activities (ISA), and 2 other interventions for Dementia and 2 related conditions. Completed, enrolled 355 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsDementia, Elderly, Sleep
CountriesUnited States
Collaborators--

Timeline

Phase 2CompletedFinished
20022003200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedApr 28, 2009
Enrollment StartAug 1, 2002
Primary CompletionApr 1, 2008
TodayJul 2, 2026
Enrollment to primary: 5.7 yearsPosted 17.2 years ago

Interventions

Control Conditionbehavioral

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/walkingbehavioral

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.