Exercise AddictionNCT03005990
The Effects of Exercise Training in Community-dwelling Elderly With Sleep Disturbances With Follow-up
A study testing Exercise training group in people with Exercise Addiction and Sleep Disorder, run by National Taiwan University Hospital at 1 site in Taiwan.
Trial summary
This study will explore the long-term effects of exercise training on body composition, cardiorespiratory fitness, and energy metabolism in the community-dwelling elderly with sleep disturbances Read more about this study
- Who is it for?
- Ages 65 years and olderHealthy volunteers can take part
- Conditions the study is for
- Exercise Addiction, Sleep Disorder
- What is being tested?
- Exercise training group
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 260 participants
- Where
- 1 siteTaiwan
- Study dates
- Dec 2016to Jan 2020
- 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
- 1. Community dwelling sedentary men and women who were 65 years or older
Who cannot join
- History of Diagnostic and Statistical Manual Diploma in Social Medicine, 4th. Edition (DSM-IV) criteria for any major psychiatric disorder, including mania or alcohol or substance abuse
- History of cognitive or other neurological disorders
- Other sleep disorders by history or documented on screening polysomnography (apnea index >10, periodic leg movement arousal index >15, or rapid eye movement (REM) behavior disorder
- Unstable or serious medical conditions or cardiopulmonary disease that contraindicate exercise
- BMI > 35 kg/m2
- Individual with a life expectancy of no more than 1 years or final stage of cancer
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effects of Exercise Training in Community-dwelling Elderly With Sleep Disturbances With Follow-up: Body Composition and Energy Metabolism
This study will explore the long-term effects of exercise training on body composition, cardiorespiratory fitness, and energy metabolism in the community-dwelling elderly with sleep disturbances
Read the detailed description
This project will be conducted in three years:
In the first year,investigators will explore the correlation of sleep parameters, dietary behavior and body composition in community-dwelling elders. Two hundred elders will be recruited to receive the actigraph accelerometer recording, sleep quality questionnaire, bio-electrical impedance analysis, heart rate variability analysis, cognitive and depression evaluation.
Secondly, the study will evaluate the efficacy and possible mechanisms of a 24-week exercise training for sleep disturbances patients. Sixty patients with sleep disturbances 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 24 weeks. The controls will receive sleep hygiene education and consultation. All measurements will be performed as described before.
Finally, all the 260 elders participating in this study will receive 12-month follow-up assessments to explore the longitudinal impact of sleep disturbances on cardiorespiratory function, body composition and metabolic function, and long-term effect of exercise training on sleep disturbances patients. Investigators 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 sleep disturbances, and the effect can be sustained for a long period.
- Conditions
- Exercise Addiction, Sleep Disorder
- Being tested
- Exercise training group
- Keywords
- Sleep disturbance, Body composition, Energy metabolism, Exercise training, Community-dwelling elderly
- Medical subject headings
- Sleep Wake Disorders, Parasomnias
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Exercise training groupOther
The conditioning period (24 weeks) of the exercise intervention was under the supervision of an exercise physiologist. The conditioning protocol included aerobic exercise sessions 3 times per week with 70-85% of maximal heart rate(max HR) for 30 mins and resistance sessions 3 times per week with an intensity of 80% of one-repetition maximum(1RM), 3 sets of 8 repetitions maximum. Each participant will measured the borg rating of perceived exertion scale and heart rate monitor during exercise. Exercise sessions were conducted in the afternoon (3-5 PM).
| Study group | Role | What they receive |
|---|---|---|
| Exercise training group | Experimental | Exercise group will attend a supervised aerobic plus resistance exercise training class 3 times a week totally for 24 weeks. Receives: Other: Exercise training group |
| Control group | No intervention | Control group only provide standard outpatient care program. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Body fat percentage
Body fat percentage in percentage.
Measured: Up to 1 year (the first year)
Secondary outcomes (25)
Body fat mass
Body fat mass in kilograms.
Measured: Up to 1 year (the first year)
Body fat free mass
Body fat free mass in kilograms.
Measured: Up to 1 year (the first year)
Body mass index
BMI in kg/m^2.
Measured: Up to 1 year (the first year)
Rest metabolic rate
Rest metabolic rate in percentage.
Measured: Up to 1 year (the first year)
Impedance
Impedance in ohm.
Measured: Up to 1 year (the first year)
Resistance
Resistance in ohm.
Measured: Up to 1 year (the first year)
Electroencephalography(EEG)
Electroencephalography was assessed during sleep.
Measured: Pretest and after 24 weeks intervention (the second year)
Electrooculography(EOG)
Electrooculography was assessed during sleep.
Measured: Pretest and after 24 weeks intervention (the second year)
Electromyography(EMG)
Electromyography was assessed during sleep.
Measured: Pretest and after 24 weeks intervention (the second year)
Electrocardiography(ECG)
Electrocardiography was assessed during sleep.
Measured: Pretest and after 24 weeks intervention (the second year)
Pittsburgh sleep quality index
Measured: Up to 1 year (the first year)
Dual energy X-ray absorptiometry
Measured: Pretest and after 24 weeks intervention (the second year)
Triglyceride
Triglyceride in mg/dL.
Measured: Pretest and after 24 weeks intervention (the second year)
Total cholesterol
Total cholesterol in mg/dL.
Measured: Pretest and after 24 weeks intervention (the second year)
Insulin
Insulin in uIU/mL.
Measured: Pretest and after 24 weeks intervention (the second year)
Fasting glucose
Fasting glucose in mg/dL.
Measured: Pretest and after 24 weeks intervention (the second year)
Glycated hemoglobin(HbA1C)
HbA1C in percentage.
Measured: Pretest and after 24 weeks intervention (the second year)
High-density lipoprotein
High-density lipoprotein in mg/dL.
Measured: Pretest and after 24 weeks intervention (the second year)
Low-density lipoprotein
Low-density lipoprotein in mg/dL.
Measured: Pretest and after 24 weeks intervention (the second year)
C-reactive protein
C-reactive protein in mg/dL.
Measured: Pretest and after 24 weeks intervention (the second year)
Heart rate variability
It is measured by the variation in the beat-to-beat interval. Methods used to detect beats is electrocardiography.
Measured: Pretest and after 24 weeks intervention (the second year)
Maximum oxygen consumption
Use treadmill exercise testing.
Measured: Pretest and after 24 weeks intervention (the second year)
Three factor eating questionnaire
Measured: Up to 1 year (the first year)
Taiwan Geriatric Depression Scale
Measured: Up to 1 year (the first year)
Groningen Activity Restriction Scale
Measured: Up to 1 year (the first year)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Dec 2016 (estimated)
- Study startDec 2016
- Primary completionJan 2020 (estimated)
- Study completionJan 2020 (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 Exercise AddictionStudies 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
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 260 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Taiwan University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Meng-Yueh Chien, doctor, Study chair, National Taiwan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03005990
- Sponsor's protocol ID
- 201512210RIND
- Status last verified
- Dec 2016
- First submitted
- 13 Dec 2016
- Last updated
- 30 Dec 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
Publications
Tseng TH, Chen HC, Wang LY, Chien MY. Effects of exercise training on sleep quality and heart rate variability in middle-aged and older adults with poor sleep quality: a randomized controlled trial. J Clin Sleep Med. 2020 Sep 15;16(9):1483-1492. doi: 10.5664/jcsm.8560.
PubMed 32394890
Study at a glance
From the registry record, last updated by the sponsor on 30 Dec 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Exercise Training in Community-dwelling Elderly With Sleep Disturbances With Follow-up: Body Composition and Energy Metabolism
- ClinicalTrials.gov ID
- NCT03005990
- Acronym / sponsor ID
- 201512210RIND
- Conditions
- Exercise Addiction, Sleep Disorder
- Keywords
- Sleep disturbance, Body composition, Energy metabolism, Exercise training, Community-dwelling elderly
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 260 participants (estimated)
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Study start
- Dec 2016
- Primary completion
- Jan 2020 (estimated)
- Study completion
- Jan 2020 (estimated)
- First posted
- 30 Dec 2016 (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.
This study will explore the long-term effects of exercise training on body composition, cardiorespiratory fitness, and energy metabolism in the community-dwelling elderly with sleep disturbances
Detailed description
This project will be conducted in three years:
In the first year,investigators will explore the correlation of sleep parameters, dietary behavior and body composition in community-dwelling elders. Two hundred elders will be recruited to receive the actigraph accelerometer recording, sleep quality questionnaire, bio-electrical impedance analysis, heart rate variability analysis, cognitive and depression evaluation.
Secondly, the study will evaluate the efficacy and possible mechanisms of a 24-week exercise training for sleep disturbances patients. Sixty patients with sleep disturbances 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 24 weeks. The controls will receive sleep hygiene education and consultation. All measurements will be performed as described before.
Finally, all the 260 elders participating in this study will receive 12-month follow-up assessments to explore the longitudinal impact of sleep disturbances on cardiorespiratory function, body composition and metabolic function, and long-term effect of exercise training on sleep disturbances patients. Investigators 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 sleep disturbances, and the effect can be sustained for a long period.
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 group | Experimental | Other: Exercise training groupExercise group will attend a supervised aerobic plus resistance exercise training class 3 times a week totally for 24 weeks. |
| Control group | No intervention | –Control group only provide standard outpatient care program. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (1 listed)
- 1. Community dwelling sedentary men and women who were 65 years or older
Key exclusion criteria (6 listed)
- History of Diagnostic and Statistical Manual Diploma in Social Medicine, 4th. Edition (DSM-IV) criteria for any major psychiatric disorder, including mania or alcohol or substance abuse
- History of cognitive or other neurological disorders
- Other sleep disorders by history or documented on screening polysomnography (apnea index >10, periodic leg movement arousal index >15, or rapid eye movement (REM) behavior disorder
- Unstable or serious medical conditions or cardiopulmonary disease that contraindicate exercise
- BMI > 35 kg/m2
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 training groupThe conditioning period (24 weeks) of the exercise intervention was under the supervision of an exercise physiologist. The conditioning protocol included aerobic exercise sessions 3 times per week with 70-85% of maximal heart rate(max HR) for 30 mins and resistance sessions 3 times per week with an intensity of 80% of one-repetition maximum(1RM), 3 sets of 8 repetitions maximum. Each participant will measured the borg rating of perceived exertion scale and heart rate monitor during exercise. Exercise sessions were conducted in the afternoon (3-5 PM). | Other | Exercise training group |
Primary outcome
Body fat percentage
Time frame: Up to 1 year (the first year)
Body fat percentage in percentage.
25 secondary outcomes
Body fat mass
Time frame: Up to 1 year (the first year)
Body fat free mass
Time frame: Up to 1 year (the first year)
Body mass index
Time frame: Up to 1 year (the first year)
Rest metabolic rate
Time frame: Up to 1 year (the first year)
Impedance
Time frame: Up to 1 year (the first year)
Resistance
Time frame: Up to 1 year (the first year)
Electroencephalography(EEG)
Time frame: Pretest and after 24 weeks intervention (the second year)
Electrooculography(EOG)
Time frame: Pretest and after 24 weeks intervention (the second year)
Electromyography(EMG)
Time frame: Pretest and after 24 weeks intervention (the second year)
Electrocardiography(ECG)
Time frame: Pretest and after 24 weeks intervention (the second year)
Pittsburgh sleep quality index
Time frame: Up to 1 year (the first year)
Dual energy X-ray absorptiometry
Time frame: Pretest and after 24 weeks intervention (the second year)
Triglyceride
Time frame: Pretest and after 24 weeks intervention (the second year)
Total cholesterol
Time frame: Pretest and after 24 weeks intervention (the second year)
Insulin
Time frame: Pretest and after 24 weeks intervention (the second year)
Fasting glucose
Time frame: Pretest and after 24 weeks intervention (the second year)
Glycated hemoglobin(HbA1C)
Time frame: Pretest and after 24 weeks intervention (the second year)
High-density lipoprotein
Time frame: Pretest and after 24 weeks intervention (the second year)
Low-density lipoprotein
Time frame: Pretest and after 24 weeks intervention (the second year)
C-reactive protein
Time frame: Pretest and after 24 weeks intervention (the second year)
Heart rate variability
Time frame: Pretest and after 24 weeks intervention (the second year)
Maximum oxygen consumption
Time frame: Pretest and after 24 weeks intervention (the second year)
Three factor eating questionnaire
Time frame: Up to 1 year (the first year)
Taiwan Geriatric Depression Scale
Time frame: Up to 1 year (the first year)
Groningen Activity Restriction Scale
Time frame: Up to 1 year (the first year)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Dec 2016.
- Derived from this study: PubMed 32394890Tseng TH, Chen HC, Wang LY, Chien MY. Effects of exercise training on sleep quality and heart rate variability in middle-aged and older adults with poor sleep quality: a randomized controlled trial. J Clin Sleep Med. 2020 Sep 15;16(9):1483-1492. doi: 10.5664/jcsm.8560.
- Individual participant dataSharing planned: Undecided
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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.
Meng-Yueh Chien, doctor study chair
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 group in people with Exercise Addiction and Sleep Disorder, 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 6 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 30 Dec 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 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?
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?
Body fat percentage (time frame: Up to 1 year (the first year)). 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 NCT03005990, 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 30 Dec 2016; AzTrials last refreshed its copy on 31 Oct 2026.