NCT00149747

Brief Summary

This study will evaluate the effect of regular aerobic exercise on improving sleep in older adults with moderate difficulty sleeping.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
66

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Aug 1999

Typical duration for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 1999

Completed
4.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2003

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2003

Completed
2 years until next milestone

First Submitted

Initial submission to the registry

September 6, 2005

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 8, 2005

Completed
8.6 years until next milestone

Results Posted

Study results publicly available

May 1, 2014

Completed
Last Updated

May 24, 2016

Status Verified

April 1, 2016

Enrollment Period

4.1 years

First QC Date

September 6, 2005

Results QC Date

June 18, 2013

Last Update Submit

April 25, 2016

Conditions

Sleep Initiation and Maintenance DisordersSleep Disorders, Intrinsic

Keywords

SleepExerciseOlder Adults

Outcome Measures

Primary Outcomes (1)

  • % Time in Stage 2 Sleep at 12 Months, Adjusted for Baseline

    Percent of total sleep time spent in Stage 2 sleep at 12 months after adjusting for baseline level of Stage 2 sleep (i.e., baseline value included as a covariate in regression models conducted).

    baseline, 12 months

Secondary Outcomes (2)

  • Sleep Disturbances

    12 months

  • Peak Exercise Oxygen Consumption

    12 months

Study Arms (2)

Exercise training

EXPERIMENTAL

Group based exercise training. Two weekly classes including aerobic endurance physical activity and strength and flexibility training, and up to three home-based sessions of similar composition of aerobic endurance, strength and flexibility training.

Behavioral: Moderate-Intensity Aerobic Physical Activity

2

PLACEBO COMPARATOR

Attention-control of exposure to study staff. Weekly general health education classes conducted in group sessions.

Behavioral: Health Education Class

Interventions

Moderate-Intensity Aerobic Physical ActivityBEHAVIORAL

Moderate-Intensity Aerobic Physical Activity. 4+ days per week, 60+ minutes per day, moderate or greater intensity physical activity

Also known as: Comprehensive fitness class
Exercise training
Health Education ClassBEHAVIORAL

2 classes a week, 90+minutes per class, general health education, excluding information on physical activity

Also known as: Healthy Aging Workshops
2

Eligibility Criteria

Age55 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Moderate difficulty sleeping unrelated to a physical illness or psychopathology (determined by the Sleep Questionnaire and Assessment of Wakefulness)
  • Currently not physically active on a regular basis
  • Body mass index less than 38

You may not qualify if:

  • Currently physically active on a regular basis
  • Diagnosed with a clinically significant sleep disorder
  • Mild or no sleep complaints (determined by the Sleep Questionnaire and Assessment of Wakefulness)
  • Unstable on medications
  • Current smoker
  • Consumes more than three alcoholic beverages per day
  • Medical condition that may limit participation in moderate-intensity exercise
  • Diagnosed with clinical psychopathology

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Stanford Prevention Research Center

Stanford, California, 94305-5705, United States

Location

Related Publications (3)

  • King AC, Oman RF, Brassington GS, Bliwise DL, Haskell WL. Moderate-intensity exercise and self-rated quality of sleep in older adults. A randomized controlled trial. JAMA. 1997 Jan 1;277(1):32-7.

    PMID: 8980207BACKGROUND

  • Bliwise DL, King AC, Harris RB, Haskell WL. Prevalence of self-reported poor sleep in a healthy population aged 50-65. Soc Sci Med. 1992 Jan;34(1):49-55. doi: 10.1016/0277-9536(92)90066-y.

    PMID: 1738856BACKGROUND

  • King AC, Pruitt LA, Woo S, Castro CM, Ahn DK, Vitiello MV, Woodward SH, Bliwise DL. Effects of moderate-intensity exercise on polysomnographic and subjective sleep quality in older adults with mild to moderate sleep complaints. J Gerontol A Biol Sci Med Sci. 2008 Sep;63(9):997-1004. doi: 10.1093/gerona/63.9.997.

    PMID: 18840807RESULT

MeSH Terms

Conditions

Sleep Initiation and Maintenance DisordersSleep Disorders, IntrinsicMotor Activity

Condition Hierarchy (Ancestors)

DyssomniasSleep Wake DisordersNervous System DiseasesMental DisordersBehavior

Results Point of Contact

Title
Abby C. King
Organization
Stanford Prevention Research Center
king@stanford.edu
6507252826

Study Officials

  • Abby C King, PhD

    Stanford University

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

September 6, 2005

First Posted

September 8, 2005

Study Start

August 1, 1999

Primary Completion

September 1, 2003

Study Completion

September 1, 2003

Last Updated

May 24, 2016

Results First Posted

May 1, 2014

Record last verified: 2016-04

Locations

US(1)