Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Integrated Care and Lower Extremity Strength Training Among Community-Dwelling Frail Older Adults in Taiwan

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02214485
Recruitment Status : Completed
First Posted : August 12, 2014
Last Update Posted : August 12, 2014
Sponsor:
Information provided by (Responsible Party):
National Taiwan University Hospital

Tracking Information
First Submitted Date  ICMJE September 30, 2013
First Posted Date  ICMJE August 12, 2014
Last Update Posted Date August 12, 2014
Study Start Date  ICMJE March 2011
Actual Primary Completion Date March 2011   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 10, 2014)
leg extension power [ Time Frame: changes in 12 weeks ]
Leg extension power is to be measured at baseline, 12 weeks (after completion of intervention), and 6 months (after completion of the study). Specifically, following warm-up of three submaximal isotonic contractions, each subject was asked to extend his knee through a range of motions from -80 to -10 degrees of knee extension (0° extension being full knee extension without hyperextension) at an initial resistance equal to 25 percent of the subject's body weight. Knee range of motion was determined goniometrically. Following the successful completion of one full repetition, additional resistance of 1 kg, or a multiple thereof, was added. The repetition was repeated until the subject was no longer able to complete one full repetition. The number is the measured leg extension power
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Integrated Care and Lower Extremity Strength Training Among Community-Dwelling Frail Older Adults in Taiwan
Official Title  ICMJE Integrated Care and Lower Extremity Strength Training Among Community-Dwelling Frail Older Adults in Taiwan
Brief Summary

Objective: To determine the differential effectiveness of integrated care (IC) and lower extremity strength training (LEST) among community-dwelling frail older adults in Taiwan.

Method: The investigators randomize participants at Bei-Hu site from the "Intervention study of Geriatric Frailty, Osteoporosis, and Depression in a Community Based Randomized Trial" into 12 weeks of either IC or LEST. Outcome assessments are performed at baseline, 12 weeks and 6 months after initiation of the interventions.

Interventions:

  1. IC: Participants visit the study site with health education, social activities, warm up, stretch, and low intensity resistance exercise for about 1 hour per week. If any medical problems or functional decline suspected during the visit, the case manager refers participants to their primary care physicians for further managements.
  2. LEST: Participants receive 2 sessions of 30-minute lower extremity strength straining using isotonic strength training machines each week. The intensity is set at 60-80% of 1 repetition maximum (RM). Evaluation of the exercise protocol are repeated every 2 weeks for individualized adjustments
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Single (Participant)
Condition  ICMJE Frailty
Intervention  ICMJE
  • Behavioral: integrated care
    Participants visit the study site with health education, social activities, warm up, stretch, and low intensity resistance exercise for about 1 hour per week. If any medical problems or functional decline suspected during the visit, the case manager refers participants to their primary care physicians for further managements.
  • Behavioral: lower extremity strength training
    Participants receive 2 sessions of 30-minute lower extremity strength straining using isotonic strength training machines each week. The intensity is set at 60-80% of 1 repetition maximum (RM). Evaluation of the exercise protocol are repeated every 2 weeks for individualized adjustments.
Study Arms  ICMJE
  • Experimental: integrated care (IC)
    Subjects will receive such care twice weekly for 12 weeks.
    Intervention: Behavioral: integrated care
  • Experimental: lower extremity strength training (LEST)
    Subjects will receive training twice weekly for 12 weeks
    Intervention: Behavioral: lower extremity strength training
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: August 10, 2014)
98
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE February 2012
Actual Primary Completion Date March 2011   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Canadian Study of Health and Aging Clinical Frailty Scale (CSHA- CFS) Chinese In-Person Interview Version score is 3-6
  • frailty index ≧ 1 (Cardiovascular Health Study Phenotypical Classification)。

Exclusion Criteria:

  • age ≧ 80 years
  • live in the nursing home.
  • can not speak Chinese,Taiwanese.
  • communication or hearing disorders affect daily activities.
  • visual impairment or daily activities affect communication.
  • another reason can not Communication or finish Canadian Study of Health and Aging Clinical Frailty Scale (CSHA- CFS) Chinese In-Person Version
  • study of Health and Aging Clinical Frailty Scale (CSHA- CFS) Chinese In-Person Interview [9, 10]Version score is 0-2 and 7.
  • communication or cognitive impairments affect daily activities(Exclusion 3-Item Recall score is <=1)
  • can not stand to walk (available walkers) 5 meters, or unsteady gait when walking five meters, it looks fast fall
  • there is serious risk of suicide (defined as: Suicide risk assessment score> = 6 points)
  • alcoholism (defined as: the problem of alcoholism Chinese people self-administered screening questionnaire CAGE have two questions (including) above answer is "yes"
  • long-term epilepsy, brain tumor, brain surgery, schizophrenia or bipolar disorder
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 65 Years to 79 Years   (Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Taiwan
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02214485
Other Study ID Numbers  ICMJE 201101038RC
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party National Taiwan University Hospital
Study Sponsor  ICMJE National Taiwan University Hospital
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Chair: Ching-Yu Chen, PHD Department of Family MedicineNational Taiwan University Hospital
PRS Account National Taiwan University Hospital
Verification Date August 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP