NCT03005990

Brief 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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
260

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Dec 2016

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2016

Completed
12 days until next milestone

First Submitted

Initial submission to the registry

December 13, 2016

Completed
17 days until next milestone

First Posted

Study publicly available on registry

December 30, 2016

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2020

Completed
Last Updated

December 30, 2016

Status Verified

December 1, 2016

Enrollment Period

3.1 years

First QC Date

December 13, 2016

Last Update Submit

December 29, 2016

Conditions

Exercise AddictionSleep Disorder

Keywords

Sleep disturbanceBody compositionEnergy metabolismExercise trainingCommunity-dwelling elderly

Outcome Measures

Primary Outcomes (1)

  • Body fat percentage

    Body fat percentage in percentage.

    Up to 1 year (the first year)

Secondary Outcomes (25)

  • Body fat mass

    Up to 1 year (the first year)

  • Body fat free mass

    Up to 1 year (the first year)

  • Body mass index

    Up to 1 year (the first year)

  • Rest metabolic rate

    Up to 1 year (the first year)

  • Impedance

    Up to 1 year (the first year)

  • +20 more secondary outcomes

Study Arms (2)

Exercise training group

EXPERIMENTAL

Exercise group will attend a supervised aerobic plus resistance exercise training class 3 times a week totally for 24 weeks.

Other: Exercise training group

Control group

NO INTERVENTION

Control group only provide standard outpatient care program.

Interventions

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).

Exercise training group

Eligibility Criteria

Age65 Years+
Sexall
Healthy VolunteersYes
Age GroupsOlder Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National Taiwan University

Taipei, Taiwan

Location

Related Publications (1)

  • 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.

    PMID: 32394890DERIVED

MeSH Terms

Conditions

Sleep Wake DisordersParasomnias

Condition Hierarchy (Ancestors)

Nervous System DiseasesNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsMental Disorders

Study Officials

  • Meng-Yueh Chien, doctor

    National Taiwan University

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 13, 2016

First Posted

December 30, 2016

Study Start

December 1, 2016

Primary Completion

January 1, 2020

Study Completion

January 1, 2020

Last Updated

December 30, 2016

Record last verified: 2016-12

Locations

TW(1)