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

NCT02214485 | Completed

• 1 other identifier: 201101038RC
• Study Type: interventional
• Target: 98
• Locations: 1 country
• Sites: 1

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. 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. 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

Keywords

frailty; exercise; intervention

Outcome Measures

Primary Outcomes (1)

• leg extension power

  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

  changes in 12 weeks

Study Arms (2)

integrated care (IC)

EXPERIMENTAL

Subjects will receive such care twice weekly for 12 weeks.

Behavioral: integrated care

lower extremity strength training (LEST)

EXPERIMENTAL

Subjects will receive training twice weekly for 12 weeks

Behavioral: lower extremity strength training

Interventions

integrated care 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.

integrated care (IC)

lower extremity strength training 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.

lower extremity strength training (LEST)

Eligibility Criteria

• Age: 65 Years - 79 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• 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)。

You may not qualify if:

• 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.
• 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

Sponsors & Collaborators

• National Taiwan University Hospital: lead

Study Sites (1)

National Taiwan University Hospital

Taipei, Taipei, 100, Taiwan

Location

MeSH Terms

Conditions

Frailty; Motor Activity

Interventions

Delivery of Health Care, Integrated

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms; Behavior

Intervention Hierarchy (Ancestors)

Delivery of Health Care; Patient Care Management; Health Services Administration; Health Care Quality, Access, and Evaluation

Study Officials

• Ching-Yu Chen, PHD

  Department of Family MedicineNational Taiwan University Hospital

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 30, 2013
• First Posted: August 12, 2014
• Study Start: March 1, 2011
• Primary Completion: March 1, 2011
• Study Completion: February 1, 2012
• Last Updated: August 12, 2014

Record last verified: 2014-08

Locations

TW (1)