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

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ClinicalTrials.gov Identifier: NCT02912338
Recruitment Status : Completed
First Posted : September 23, 2016
Last Update Posted : July 22, 2019
Sponsor:
Information provided by (Responsible Party):
Chiu Shu-Ching, Central Taiwan University of Science and Technology

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 Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 123 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Supportive Care
Study Start Date : September 2015
Actual Primary Completion Date : March 2016
Actual Study Completion Date : March 2016

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



Primary Outcome Measures :
  1. Body Composition [ Time Frame: 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.

  2. body weight [ Time Frame: Change kg from baseline to follow up (12 weeks later) ]
    Weighing scales in kilograms

  3. BMI [ Time Frame: Change from baseline to follow up (12 weeks later) ]
    kg/m2

  4. hand grip [ Time Frame: Change from baseline to follow up (12 weeks later) ]
    Jamar Handgrip Dynamometer

  5. hand pinch [ Time Frame: Change kg from baseline to follow up (12 weeks later) ]
    Lafayette Hydraulic Pinch Gauge 5030P1

  6. Activities of daily living [ Time Frame: 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.

  7. Quality of Life [ Time Frame: 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)



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Ages Eligible for Study:   60 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. aged and elderly over 60 years old and no exercise restrictions.
  2. conscious clear, able to communicate with to the traditional Chinese language or Taiwanese.
  3. in the past three months living in long-term care institutions.
  4. in the last month the subject biased static life
  5. 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:

  1. In the past three months have unstable weight (> ± 4 kg).
  2. 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).
  3. limb unable to anti-gravity completely
  4. severe dementia (Clinical Dementia Rating (CDR) Scale Clinical Dementia Rating, CDR 3-5 points).
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Chiu Shu-Ching, Senior Lecturer, PhD candidate, Central Taiwan University of Science and Technology
ClinicalTrials.gov Identifier: NCT02912338    
Other Study ID Numbers: CTU104-PC-014
First Posted: September 23, 2016    Key Record Dates
Last Update Posted: July 22, 2019
Last Verified: July 2019
Keywords provided by Chiu Shu-Ching, Central Taiwan University of Science and Technology:
Sarcopenic obesity
Body composition
Physical function
quality of life
long term care
Additional relevant MeSH terms:
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Sarcopenia
Muscular Atrophy
Neuromuscular Manifestations
Neurologic Manifestations
Nervous System Diseases
Atrophy
Pathological Conditions, Anatomical