Clinical trial NCT02214485: Integrated Care and Lower Extremity Strength Training Among Community-Dwelling Frail Older Adults in Taiwan
Official title: Integrated Care and Lower Extremity Strength Training Among Community-Dwelling Frail Older Adults in Taiwan
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Frailty
Keywords: frailty
exercise
intervention
Lead sponsor: National Taiwan University Hospital
Sponsor class: OTHER
First posted: 2014-08-12
Enrollment: 98
Sex: ALL
Minimum age (years): 65
Maximum age (years): 79
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP

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


Eligibility 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

Primary outcomes:
measure: leg extension power
timeFrame: changes in 12 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: National Taiwan University Hospital
Study officials:
affiliation: Department of Family MedicineNational Taiwan University Hospital
name: Ching-Yu Chen, PHD
role: STUDY_CHAIR
References: