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

NCT ID: NCT02214485

Last Updated: 2014-08-12

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 98 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-03-31
• Study Completion Date: 2012-02-29

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

Conditions

Frailty

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Blinding Strategy: SINGLE

Study Groups

integrated care (IC)

Subjects will receive such care twice weekly for 12 weeks.

Group Type: EXPERIMENTAL

integrated care

Intervention Type: BEHAVIORAL

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.

lower extremity strength training (LEST)

Subjects will receive training twice weekly for 12 weeks

Group Type: EXPERIMENTAL

lower extremity strength training

Intervention Type: BEHAVIORAL

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.

Interventions

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.

Intervention Type: 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.

Intervention Type: BEHAVIORAL

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

• Minimum Eligible Age: 65 Years
• Maximum Eligible Age: 79 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Taiwan University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Ching-Yu Chen, PHD

Role: STUDY_CHAIR

Department of Family MedicineNational Taiwan University Hospital

Locations

National Taiwan University Hospital

Taipei, Taipei, Taiwan

Countries

Taiwan

Other Identifiers

201101038RC

Identifier Type: -

Identifier Source: org_study_id