Back to resultsThe Effectiveness of Lifestyle Intervention on Body Composition, Physical Performances and Quality of Life Among Elderly People in Long-term Care Facilities
Primary Purpose
Sarcopenia, Obesity
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Resistant Training
Control Group
Sponsored by
About this trial
This is an interventional supportive care trial for Sarcopenia focused on measuring Sarcopenic obesity, Body composition, Physical function, quality of life, long term care
Eligibility Criteria
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).
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Resistant Training Group
Control Group
Arm Description
sandbag 2-5lb, grip ball, twice/week, Duration:12 weeks
not change lifestyle
Outcomes
Primary Outcome Measures
Body Composition
measuring machine: Bioelectrical impedance analysis (BIA) estimates body composition of fat and lean tissue.
body weight
Weighing scales in kilograms
BMI
kg/m2
hand grip
Jamar Handgrip Dynamometer
hand pinch
Lafayette Hydraulic Pinch Gauge 5030P1
Activities of daily living
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
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)
Secondary Outcome Measures
Full Information
NCT ID
NCT02912338
First Posted
September 9, 2016
Last Updated
July 18, 2019
Sponsor
Central Taiwan University of Science and Technology
1. Study Identification
Unique Protocol Identification Number
NCT02912338
Brief Title
The Effectiveness of Lifestyle Intervention on Body Composition, Physical Performances and Quality of Life Among Elderly People in Long-term Care Facilities
Study Type
Interventional
2. Study Status
Record Verification Date
July 2019
Overall Recruitment Status
Completed
Study Start Date
September 2015 (undefined)
Primary Completion Date
March 2016 (Actual)
Study Completion Date
March 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Central Taiwan University of Science and Technology
4. Oversight
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sarcopenia, Obesity
Keywords
Sarcopenic obesity, Body composition, Physical function, quality of life, long term care
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Non-Randomized
Enrollment
123 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Resistant Training Group
Arm Type
Experimental
Arm Description
sandbag 2-5lb, grip ball, twice/week, Duration:12 weeks
Arm Title
Control Group
Arm Type
Active Comparator
Arm Description
not change lifestyle
Intervention Type
Behavioral
Intervention Name(s)
Resistant Training
Intervention Type
Other
Intervention Name(s)
Control Group
Primary Outcome Measure Information:
Title
Body Composition
Description
measuring machine: Bioelectrical impedance analysis (BIA) estimates body composition of fat and lean tissue.
Time Frame
Change gram, kg and percentage from baseline to follow up (12 weeks later)
Title
body weight
Description
Weighing scales in kilograms
Time Frame
Change kg from baseline to follow up (12 weeks later)
Title
BMI
Description
kg/m2
Time Frame
Change from baseline to follow up (12 weeks later)
Title
hand grip
Description
Jamar Handgrip Dynamometer
Time Frame
Change from baseline to follow up (12 weeks later)
Title
hand pinch
Description
Lafayette Hydraulic Pinch Gauge 5030P1
Time Frame
Change kg from baseline to follow up (12 weeks later)
Title
Activities of daily living
Description
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.
Time Frame
Change score from baseline to follow up (12 weeks later)
Title
Quality of Life
Description
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)
Time Frame
Change score from baseline to follow up (12 weeks later)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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).
12. IPD Sharing Statement
Citations:
PubMed Identifier
32279360
Citation
Chang SF, Chiu SC. Effect of resistance training on quality of life in older people with sarcopenic obesity living in long-term care institutions: A quasi-experimental study. J Clin Nurs. 2020 Jul;29(13-14):2544-2556. doi: 10.1111/jocn.15277. Epub 2020 Apr 24.
Results Reference
derived
PubMed Identifier
29357826
Citation
Chiu SC, Yang RS, Yang RJ, Chang SF. Effects of resistance training on body composition and functional capacity among sarcopenic obese residents in long-term care facilities: a preliminary study. BMC Geriatr. 2018 Jan 22;18(1):21. doi: 10.1186/s12877-018-0714-6.
Results Reference
derived
Learn more about this trial
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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