Sleep Initiation and Maintenance DisordersPhase 2/3RTCNCT00149747
The Effectiveness of Regular Exercise on Improving Sleep in Older Adults
A Phase 2/3 study testing Moderate-Intensity Aerobic Physical Activity and Health Education Class in people with Sleep Initiation and Maintenance Disorders and Sleep Disorders, Intrinsic, run by Stanford University at 1 site in United States.
Trial summary
This study will evaluate the effect of regular aerobic exercise on improving sleep in older adults with moderate difficulty sleeping. Read more about this study
- Who is it for?
- Ages 55 years and olderHealthy volunteers can take part
- Conditions the study is for
- Sleep Initiation and Maintenance Disorders, Sleep Disorders, Intrinsic
- What is being tested?
- Moderate-Intensity Aerobic Physical Activity and Health Education Class
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 66 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 1999to Sep 2003
- Phase
- Phase 2/3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 55 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Stanford Prevention Research Center
Stanford, California, 94305-5705
About this study
Official title: Promoting Exercise, Sleep and Well-Being in Older Adults
This study will evaluate the effect of regular aerobic exercise on improving sleep in older adults with moderate difficulty sleeping.
Read the detailed description
Sleep deprivation is a common problem among older adults. It is often at the root of increased mortality and some psychiatric disorders. Regular participation in a medium-intensity exercise regimen may help people sleep better. This study will assess the effectiveness of a regular exercise program on improving sleep in older adults with moderate difficulty sleeping.
Participants will be randomly assigned to one of two conditions. One group will partake in a moderate-intensity physical activity training regimen. The other group will act as a non-exercise attention-control comparison group. Each group will undergo its assigned treatment for 12 months. Sleep quantity and quality will be measured objectively using in-home polysomnography. Subjective sleep quality and health-related quality of life measures will be evaluated with questionnaires. All measurements will be performed at the beginning of the study, Month 6, and Month 12.
- Being tested
- Moderate-Intensity Aerobic Physical Activity, Health Education Class
- Keywords
- Sleep, Exercise, Older Adults
- Medical subject headings
- Sleep Initiation and Maintenance Disorders, Sleep Disorders, Intrinsic, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Moderate-Intensity Aerobic Physical ActivityBehavioural
Also called Comprehensive fitness class
Moderate-Intensity Aerobic Physical Activity. 4+ days per week, 60+ minutes per day, moderate or greater intensity physical activity
Health Education ClassBehavioural
Also called Healthy Aging Workshops
2 classes a week, 90+minutes per class, general health education, excluding information on physical activity
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Behavioral: Health Education Class |
What is being measured
The primary outcome is the main question the study is designed to answer.
% 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).
Measured: baseline, 12 months
Secondary outcomes (2)
Sleep Disturbances
Self-reported sleep disturbance subscale on Pittsburgh Sleep Quality Index Subscale consists of 9 items scored on a range of 0 to 3, 0 indicating no disturbance and 3 indicating frequent disturbance.
All 9 items are summed, and the summary scores is captured by 1 of 4 categories ranging from 0 to 3, with 0 indicating less frequent disturbances and 3 indicating greater frequency of disturbances.
Measured: 12 months
Peak Exercise Oxygen Consumption
Peak oxygen consumption measured during symptom limited treadmill exercise stress test
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Sep 2005 (estimated)
- Study startAug 1999
- Primary completionSep 2003
- Study completionSep 2003
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Sleep Initiation and Maintenance DisordersStudies of the same condition, open and under way.
- More trials run by Stanford UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 66 participants (actual)
Sponsor and investigators
- Lead sponsor
- Stanford University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Responsible party
- Principal investigator, Abby C King, Stanford University
- Investigators
- Abby C King, PhD, Principal investigator, Stanford University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00149747
- Sponsor's protocol ID
- R01MH058853
- Other IDs
- R01MH058853, DAHBR HB-C
- Acronym
- RTC
- Status last verified
- Apr 2016
- First submitted
- 6 Sep 2005
- Last updated
- 24 May 2016
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
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.
PubMed 8980207Bliwise 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.
PubMed 1738856King 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.
PubMed 18840807
Study at a glance
From the registry record, last updated by the sponsor on 24 May 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Promoting Exercise, Sleep and Well-Being in Older Adults
- ClinicalTrials.gov ID
- NCT00149747
- Acronym / sponsor ID
- RTC / R01MH058853
- Keywords
- Sleep, Exercise, Older Adults
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 66 participants (actual)
- Lead sponsor
- Stanford UniversityUniversity, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Study start
- Aug 1999
- Primary completion
- Sep 2003 (actual)
- Study completion
- Sep 2003 (actual)
- First posted
- 8 Sep 2005 (estimated)
- Results
- Posted 1 May 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study will evaluate the effect of regular aerobic exercise on improving sleep in older adults with moderate difficulty sleeping.
Detailed description
Sleep deprivation is a common problem among older adults. It is often at the root of increased mortality and some psychiatric disorders. Regular participation in a medium-intensity exercise regimen may help people sleep better. This study will assess the effectiveness of a regular exercise program on improving sleep in older adults with moderate difficulty sleeping.
Participants will be randomly assigned to one of two conditions. One group will partake in a moderate-intensity physical activity training regimen. The other group will act as a non-exercise attention-control comparison group. Each group will undergo its assigned treatment for 12 months. Sleep quantity and quality will be measured objectively using in-home polysomnography. Subjective sleep quality and health-related quality of life measures will be evaluated with questionnaires. All measurements will be performed at the beginning of the study, Month 6, and Month 12.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Exercise training | Experimental | Behavioral: Moderate-Intensity Aerobic Physical ActivityGroup 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. |
| 2 | Placebo comparator | Behavioral: Health Education ClassAttention-control of exposure to study staff. Weekly general health education classes conducted in group sessions. |
Who may qualify
- Ages
- 55 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Moderate-Intensity Aerobic Physical ActivityAlso: Comprehensive fitness classModerate-Intensity Aerobic Physical Activity. 4+ days per week, 60+ minutes per day, moderate or greater intensity physical activity | Behavioural | Exercise training |
| Health Education ClassAlso: Healthy Aging Workshops2 classes a week, 90+minutes per class, general health education, excluding information on physical activity | Behavioural | 2 |
Primary outcome
% Time in Stage 2 Sleep at 12 Months, Adjusted for Baseline
Time frame: baseline, 12 months
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).
2 secondary outcomes
Sleep Disturbances
Time frame: 12 months
Peak Exercise Oxygen Consumption
Time frame: 12 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 May 2016.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 8980207King 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.
- Background: PubMed 1738856Bliwise 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.
- Results publication: PubMed 18840807King 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.
- Click here for a description of the study.Link provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Abby C King, PhD principal investigator
Stanford University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Moderate-Intensity Aerobic Physical Activity and Health Education Class in people with Sleep Initiation and Maintenance Disorders and Sleep Disorders, Intrinsic, run by Stanford University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 May 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 1 May 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
% Time in Stage 2 Sleep at 12 Months, Adjusted for Baseline (time frame: baseline, 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00149747, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 May 2016.