Long-term Follow-up of Functional Performance and Exercise Efficacy in Community-dwelling Elderly With Insomnia

Insomnia Clinical Trial

Official title:

Long-term Follow-up of Functional Performance and Exercise Efficacy in Community-dwelling Elderly With Insomnia

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01689818
• Other study ID #: 201012130RB
• Status: Recruiting
• Phase: N/A
• First received: August 28, 2012
• Last updated: September 20, 2012
• Start date: August 2011
• Est. completion date: July 2014

Study information

• Verified date: September 2012
• Source: National Taiwan University Hospital
• Contact: Meng-Yueh Chien, Ph.D
• Phone: 886-2-3366-8141
• Email: mychien[@]ntu.edu.tw
• Is FDA regulated: No
• Health authority: Taiwan: Department of Health
• Study type: Interventional

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 250
• Est. completion date: July 2014
• Est. primary completion date: July 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 65 Years and older

Eligibility

Inclusion Criteria:

• above 65 y/o elderly

Exclusion Criteria:

• 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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Insomnia

Intervention

Other:
• exercise training
exercise training program which included aerobic exercise for 3 times per week.

Locations

Country	Name	City	State
Taiwan	Meng-Yueh Chien	Taipei

Sponsors (1)

Lead Sponsor	Collaborator
National Taiwan University Hospital

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	cognitive function		16 weeks	No
Primary	functional performance	physical fitness and physical disability	16 weeks	No
Secondary	depression		16 weeks	No