The Effects of Exercise Training in Community-dwelling Elderly With Sleep Disturbances With Follow-up

December 29, 2016 updated by: National Taiwan University Hospital

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

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Unknown

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
260

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Taiwan
      • Taipei, Taiwan
        • National Taiwan University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

65 years and older (Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

1. Community dwelling sedentary men and women who were 65 years or older

Exclusion Criteria:

  1. 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
  2. History of cognitive or other neurological disorders
  3. 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
  4. Unstable or serious medical conditions or cardiopulmonary disease that contraindicate exercise
  5. BMI > 35 kg/m2
  6. Individual with a life expectancy of no more than 1 years or final stage of cancer

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Exercise training group
Exercise group will attend a supervised aerobic plus resistance exercise training class 3 times a week totally for 24 weeks.
Other: Exercise training group
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).
No Intervention: Control group
Control group only provide standard outpatient care program.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Body fat percentage
Time Frame: Up to 1 year (the first year)
Body fat percentage in percentage.
Up to 1 year (the first year)

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Body fat mass
Time Frame: Up to 1 year (the first year)
Body fat mass in kilograms.
Up to 1 year (the first year)
Body fat free mass
Time Frame: Up to 1 year (the first year)
Body fat free mass in kilograms.
Up to 1 year (the first year)
Body mass index
Time Frame: Up to 1 year (the first year)
BMI in kg/m^2.
Up to 1 year (the first year)
Rest metabolic rate
Time Frame: Up to 1 year (the first year)
Rest metabolic rate in percentage.
Up to 1 year (the first year)
Impedance
Time Frame: Up to 1 year (the first year)
Impedance in ohm.
Up to 1 year (the first year)
Resistance
Time Frame: Up to 1 year (the first year)
Resistance in ohm.
Up to 1 year (the first year)
Electroencephalography(EEG)
Time Frame: Pretest and after 24 weeks intervention (the second year)
Electroencephalography was assessed during sleep.
Pretest and after 24 weeks intervention (the second year)
Electrooculography(EOG)
Time Frame: Pretest and after 24 weeks intervention (the second year)
Electrooculography was assessed during sleep.
Pretest and after 24 weeks intervention (the second year)
Electromyography(EMG)
Time Frame: Pretest and after 24 weeks intervention (the second year)
Electromyography was assessed during sleep.
Pretest and after 24 weeks intervention (the second year)
Electrocardiography(ECG)
Time Frame: Pretest and after 24 weeks intervention (the second year)
Electrocardiography was assessed during sleep.
Pretest and after 24 weeks intervention (the second year)
Pittsburgh sleep quality index
Time Frame: Up to 1 year (the first year)
Up to 1 year (the first year)
Dual energy X-ray absorptiometry
Time Frame: Pretest and after 24 weeks intervention (the second year)
Pretest and after 24 weeks intervention (the second year)
Triglyceride
Time Frame: Pretest and after 24 weeks intervention (the second year)
Triglyceride in mg/dL.
Pretest and after 24 weeks intervention (the second year)
Total cholesterol
Time Frame: Pretest and after 24 weeks intervention (the second year)
Total cholesterol in mg/dL.
Pretest and after 24 weeks intervention (the second year)
Insulin
Time Frame: Pretest and after 24 weeks intervention (the second year)
Insulin in uIU/mL.
Pretest and after 24 weeks intervention (the second year)
Fasting glucose
Time Frame: Pretest and after 24 weeks intervention (the second year)
Fasting glucose in mg/dL.
Pretest and after 24 weeks intervention (the second year)
Glycated hemoglobin(HbA1C)
Time Frame: Pretest and after 24 weeks intervention (the second year)
HbA1C in percentage.
Pretest and after 24 weeks intervention (the second year)
High-density lipoprotein
Time Frame: Pretest and after 24 weeks intervention (the second year)
High-density lipoprotein in mg/dL.
Pretest and after 24 weeks intervention (the second year)
Low-density lipoprotein
Time Frame: Pretest and after 24 weeks intervention (the second year)
Low-density lipoprotein in mg/dL.
Pretest and after 24 weeks intervention (the second year)
C-reactive protein
Time Frame: Pretest and after 24 weeks intervention (the second year)
C-reactive protein in mg/dL.
Pretest and after 24 weeks intervention (the second year)
Heart rate variability
Time Frame: Pretest and after 24 weeks intervention (the second year)
It is measured by the variation in the beat-to-beat interval. Methods used to detect beats is electrocardiography.
Pretest and after 24 weeks intervention (the second year)
Maximum oxygen consumption
Time Frame: Pretest and after 24 weeks intervention (the second year)
Use treadmill exercise testing.
Pretest and after 24 weeks intervention (the second year)
Three factor eating questionnaire
Time Frame: Up to 1 year (the first year)
Up to 1 year (the first year)
Taiwan Geriatric Depression Scale
Time Frame: Up to 1 year (the first year)
Up to 1 year (the first year)
Groningen Activity Restriction Scale
Time Frame: Up to 1 year (the first year)
Up to 1 year (the first year)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
National Taiwan University Hospital

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Chair: Meng-Yueh Chien, doctor, National Taiwan University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
December 1, 2016

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
January 1, 2020

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
January 1, 2020

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
December 13, 2016

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 29, 2016

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
December 30, 2016

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
December 30, 2016

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 29, 2016

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
December 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 201512210RIND

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Sleep Disorder

Clinical Trials on Exercise training group

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings