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

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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

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

Condition or disease Intervention/treatment Phase
Frailty Behavioral: integrated care Behavioral: lower extremity strength training Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 98 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Single (Participant)
Official Title: Integrated Care and Lower Extremity Strength Training Among Community-Dwelling Frail Older Adults in Taiwan
Study Start Date : March 2011
Actual Primary Completion Date : March 2011
Actual Study Completion Date : February 2012

Arm Intervention/treatment
Experimental: integrated care (IC)
Subjects will receive such care twice weekly for 12 weeks.
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.

Experimental: lower extremity strength training (LEST)
Subjects will receive training twice weekly for 12 weeks
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.




Primary Outcome Measures :
  1. 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



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Ages Eligible for Study:   65 Years to 79 Years   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02214485


Locations
Taiwan
National Taiwan University Hospital
Taipei, Taiwan, 100
Sponsors and Collaborators
National Taiwan University Hospital
Investigators
Study Chair: Ching-Yu Chen, PHD Department of Family MedicineNational Taiwan University Hospital

Responsible Party: National Taiwan University Hospital
ClinicalTrials.gov Identifier: NCT02214485     History of Changes
Other Study ID Numbers: 201101038RC
First Posted: August 12, 2014    Key Record Dates
Last Update Posted: August 12, 2014
Last Verified: August 2014

Keywords provided by National Taiwan University Hospital:
frailty
exercise
intervention