InsomniaNCT01689818
Long-term Follow-up of Functional Performance and Exercise Efficacy in Community-dwelling Elderly With Insomnia
A study testing exercise training in people with Insomnia, run by National Taiwan University Hospital at 1 site in Taiwan.
Trial summary
Poor sleep quality has been recognized as a major public health concern in the world. The prevalence of insomnia in Taiwan is comparable to that of Western countries. It is estimated that up to 50% of elderly complain about their sleep. Read more about this study
- Who is it for?
- Ages 65 years and olderHealthy volunteers can take part
- Conditions the study is for
- Insomnia
- What is being tested?
- exercise training
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 250 participants
- Where
- 1 siteTaiwan
- Study dates
- Aug 2011to Jul 2014
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 65 years and older
- All sexes
- Healthy volunteers accepted
- Older adult
Who may be able to join
- above 65 y/o elderly
Who cannot join
- psychiatric diagnosis (DSM-IV) of serious mental illness, including severe depression symptoms, mania, Alcohol or drug abuse
- with other sleep disorders such as sleep apnea, periodic limb twitching, or fast moving eye movement behavior disorder
- cognitive and other neurological diseases history who can not communicate
- Unstable serious illness or sports contraindicated cardiopulmonary disease such as diabetes, hypertension, and other cardiovascular disease, neurological injury patients
- body mass index greater than 35 kg/ M 2 or more
Trial locations and contacts
1 site in 1 country.
About this study
Poor sleep quality has been recognized as a major public health concern in the world. The prevalence of insomnia in Taiwan is comparable to that of Western countries. It is estimated that up to 50% of elderly complain about their sleep. Insomnia is associated with anxiety, falls, or cognitive impairment in the elderly, which may compromise their daily activities function and quality of life.
Recently, researches have demonstrated the associations between insomnia and endocrine system dysfunction, metabolic disorders, and cardiovascular events and death. Therefore, it is an important issue to improve sleep quality of the elders. The side-effects of pharmacological treatments and high-cost of cognitive behavior therapy limit their accessibility and effectiveness, and exercise training has been expected to provide an alternative intervention for insomnia. However, the long-term impact of insomnia on health-related fitness and metabolic function, and the effect of exercise training remain inconclusive. Therefore, the study hypothesis is that exercise training affect functional performance and quality of life in community-dwelling elderly with insomnia.
Read the detailed description
This project will be conducted in three years:
In the first year, we will compare the cardiorespiratory function, body composition, physical activity, and metabolic biochemistry parameters in community-dwelling elders with good and poor sleep quality. One hundred and twenty elders will be recruited to receive the actigraph accelermometer recording, sleep quality questionnaire, exercise test, bioelectrical impedance analysis, heart rate variability analysis, cognitive and depression evaluation, and biochemistry analysis.
Secondly, the study will evaluate the efficacy and possible mechanisms of a 16-week exercise training for insomnia. Sixty patients with insomnia elders will be randomized to exercise group or control group. Participants in the exercise group will receive aerobic and resistance exercise 3 times per week for 16 weeks. The controls will receive sleep hygiene education and consultation. All measurements will be performed as described before.
Finally, all the 120 elders participating in this study will receive 12-month follow-up assessments to explore the longitudinal impact of insomnia on cardiorespiratory function, body composition and metabolic function, and long-term effect of exercise training on insomnia. We expect elders with poor sleep quality have lower level of health-related fitness and metabolic function; exercise training is effective to improve sleep quality, metabolic function and general health in the elders with insomnia, and the effect can be sustained for a long period.
- Conditions
- Insomnia
- Being tested
- exercise training
- Keywords
- insomnia, elderly, exercise training
- Medical subject headings
- Sleep Initiation and Maintenance Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
exercise trainingOther
exercise training program which included aerobic exercise for 3 times per week.
| Study group | Role | What they receive |
|---|---|---|
| exercise training | Experimental | exercise training program which included aerobic exercise for 3 times per week. Receives: Other: exercise training |
| control | No intervention | lifestyle counseling |
What is being measured
The primary outcome is the main question the study is designed to answer.
functional performance
physical fitness and physical disability
Measured: 16 weeks
Secondary outcomes (1)
depression
Measured: 16 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Sep 2012 (estimated)
- Study startAug 2011
- Primary completionJul 2014 (estimated)
- Study completionJul 2014 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for InsomniaStudies of the same condition, open and under way.
- More trials run by National Taiwan University HospitalThe 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 250 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Taiwan University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Meng-Yueh Chien, PhD, Principal investigator, National Taiwan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01689818
- Sponsor's protocol ID
- 201012130RB
- Status last verified
- Sep 2012
- First submitted
- 28 Aug 2012
- Last updated
- 21 Sep 2012
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Chien MY, Chen HC. Poor sleep quality is independently associated with physical disability in older adults. J Clin Sleep Med. 2015 Mar 15;11(3):225-32. doi: 10.5664/jcsm.4532.
PubMed 25515275
Study at a glance
From the registry record, last updated by the sponsor on 21 Sep 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Long-term Follow-up of Functional Performance and Exercise Efficacy in Community-dwelling Elderly With Insomnia
- ClinicalTrials.gov ID
- NCT01689818
- Acronym / sponsor ID
- 201012130RB
- Conditions
- Insomnia
- Keywords
- insomnia, elderly, exercise training
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 250 participants (estimated)
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Study start
- Aug 2011
- Primary completion
- Jul 2014 (estimated)
- Study completion
- Jul 2014 (estimated)
- First posted
- 21 Sep 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Poor sleep quality has been recognized as a major public health concern in the world. The prevalence of insomnia in Taiwan is comparable to that of Western countries. It is estimated that up to 50% of elderly complain about their sleep. Insomnia is associated with anxiety, falls, or cognitive impairment in the elderly, which may compromise their daily activities function and quality of life.
Recently, researches have demonstrated the associations between insomnia and endocrine system dysfunction, metabolic disorders, and cardiovascular events and death. Therefore, it is an important issue to improve sleep quality of the elders. The side-effects of pharmacological treatments and high-cost of cognitive behavior therapy limit their accessibility and effectiveness, and exercise training has been expected to provide an alternative intervention for insomnia. However, the long-term impact of insomnia on health-related fitness and metabolic function, and the effect of exercise training remain inconclusive. Therefore, the study hypothesis is that exercise training affect functional performance and quality of life in community-dwelling elderly with insomnia.
Detailed description
This project will be conducted in three years:
In the first year, we will compare the cardiorespiratory function, body composition, physical activity, and metabolic biochemistry parameters in community-dwelling elders with good and poor sleep quality. One hundred and twenty elders will be recruited to receive the actigraph accelermometer recording, sleep quality questionnaire, exercise test, bioelectrical impedance analysis, heart rate variability analysis, cognitive and depression evaluation, and biochemistry analysis.
Secondly, the study will evaluate the efficacy and possible mechanisms of a 16-week exercise training for insomnia. Sixty patients with insomnia elders will be randomized to exercise group or control group. Participants in the exercise group will receive aerobic and resistance exercise 3 times per week for 16 weeks. The controls will receive sleep hygiene education and consultation. All measurements will be performed as described before.
Finally, all the 120 elders participating in this study will receive 12-month follow-up assessments to explore the longitudinal impact of insomnia on cardiorespiratory function, body composition and metabolic function, and long-term effect of exercise training on insomnia. We expect elders with poor sleep quality have lower level of health-related fitness and metabolic function; exercise training is effective to improve sleep quality, metabolic function and general health in the elders with insomnia, and the effect can be sustained for a long period.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| exercise training | Experimental | Other: exercise trainingexercise training program which included aerobic exercise for 3 times per week. |
| control | No intervention | –lifestyle counseling |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (1 listed)
- above 65 y/o elderly
Key exclusion criteria (5 listed)
- psychiatric diagnosis (DSM-IV) of serious mental illness, including severe depression symptoms, mania, Alcohol or drug abuse
- with other sleep disorders such as sleep apnea, periodic limb twitching, or fast moving eye movement behavior disorder
- cognitive and other neurological diseases history who can not communicate
- Unstable serious illness or sports contraindicated cardiopulmonary disease such as diabetes, hypertension, and other cardiovascular disease, neurological injury patients
- body mass index greater than 35 kg/ M 2 or more
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 |
|---|---|---|
| exercise trainingexercise training program which included aerobic exercise for 3 times per week. | Other | exercise training |
Primary outcome
functional performance
Time frame: 16 weeks
physical fitness and physical disability
1 secondary outcome
depression
Time frame: 16 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Sep 2012.
- Derived from this study: PubMed 25515275Chien MY, Chen HC. Poor sleep quality is independently associated with physical disability in older adults. J Clin Sleep Med. 2015 Mar 15;11(3):225-32. doi: 10.5664/jcsm.4532.
Related trials for Insomnia
RecruitingObservational study
Asprosin and miRNA Expression in Young Women With Metabolic Syndrome
Metabolic Syndrome, Insulin Resistance
Recruiting
Effects of a Hemp Seed-based Product on Appetite and Health Parameters
Healthy
Recruiting
Perioperative Meditation Music Intervention in Patients With Type 2 Diabetes Undergoing Elective Surgery
Diabetes Type 2
Active, not recruitingObservational study
Neuropathic Spinal Pain in Ankylosing Spondylitis
Ankylosing Spondylitis
Active, not recruiting
Health enSuite Insomnia: an App-based Treatment for Adult Chronic Insomnia
Insomnia
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.
Meng-Yueh Chien, PhD principal investigator
National Taiwan University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing exercise training in people with Insomnia, run by National Taiwan University Hospital at 1 site in Taiwan.
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 1 inclusion and 5 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: status not confirmed, as of the sponsor's last update on 21 Sep 2012. 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 Taiwan. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Meng-Yueh Chien, Ph.D (886-2-3366-8141, mychien@ntu.edu.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
functional performance (time frame: 16 weeks). 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 NCT01689818, which also lists 1 linked publication.
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 21 Sep 2012.