The Effectiveness of Lifestyle Intervention on Body Composition, Physical Performances and Quality of Life Among Elderly People in Long-term Care Facilities

Sponsor

Central Taiwan University of Science and Technology (Other)

Overall Status

Completed

CT.gov ID

NCT02912338

Collaborator

(none)

123

Enrollment

Arms

Duration (Months)

Study Details

Study Description

Brief Summary

Purpose: To understand the change in body composition, physical functions and quality of life of elderly residents with sarcopenic obesity in LTC facilities after the implementation of exercise intervention.

Condition or Disease	Intervention/Treatment	Phase
Sarcopenia Obesity	Behavioral: Resistant Training Other: Control Group	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

123 participants

Allocation:

Non-Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Outcomes Assessor)

Primary Purpose:

Supportive Care

Study Start Date :

Sep 1, 2015

Actual Primary Completion Date :

Mar 1, 2016

Actual Study Completion Date :

Mar 1, 2016

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Resistant Training Group sandbag 2-5lb, grip ball, twice/week, Duration:12 weeks	Behavioral: Resistant Training
Active Comparator: Control Group not change lifestyle	Other: Control Group

Arm

Intervention/Treatment

Experimental: Resistant Training Group

sandbag 2-5lb, grip ball, twice/week, Duration:12 weeks

Behavioral: Resistant Training

Active Comparator: Control Group

not change lifestyle

Other: Control Group

Outcome Measures

Primary Outcome Measures

Body Composition [Change gram, kg and percentage from baseline to follow up (12 weeks later)]
measuring machine: Bioelectrical impedance analysis (BIA) estimates body composition of fat and lean tissue.
body weight [Change kg from baseline to follow up (12 weeks later)]
Weighing scales in kilograms
BMI [Change from baseline to follow up (12 weeks later)]
kg/m2
hand grip [Change from baseline to follow up (12 weeks later)]
Jamar Handgrip Dynamometer
hand pinch [Change kg from baseline to follow up (12 weeks later)]
Lafayette Hydraulic Pinch Gauge 5030P1
Activities of daily living [Change score from baseline to follow up (12 weeks later)]
Functional Independence Measure (FIM) included 18 items, covering 6 situations in the burden of personal care, specifically self-care, mobility, transfers, sphincter management, communication, and social cognition. A high score indicates better function.
Quality of Life [Change score from baseline to follow up (12 weeks later)]
Short Form 8 health survey (SF8)included the items focusing on physical and mental health; EuroQol-5D (EQ-5D) includes the EQ-visual analogue scale (VAS) and the EQ-5D descriptive system. EQ-VAS documents the participant's self-reported health on a VAS of 100-0. The EQ-5D-3L descriptive system consists of five dimensions, namely mobility, self-care, usual activities, pain/discomfort and anxiety/depression, all with three function levels (no problem = 1; some problems = 2; severe problems = 3)

Eligibility Criteria

Criteria

Ages Eligible for Study:

60 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

aged and elderly over 60 years old and no exercise restrictions.
conscious clear, able to communicate with to the traditional Chinese language or Taiwanese.
in the past three months living in long-term care institutions.
in the last month the subject biased static life
in a stable condition with enough energy: to maintain the support of at least one hour sitting in a wheelchair or bed edge.

Exclusion Criteria:

In the past three months have unstable weight (> ± 4 kg).
severe disease states, such as severe heart and lung liver and kidney disease, a serious cancer, severe malnutrition (Mini Nutritional Assessment Scale 0-7 points).
limb unable to anti-gravity completely
severe dementia (Clinical Dementia Rating (CDR) Scale Clinical Dementia Rating, CDR 3-5 points).