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

Obesity Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02912338
• Other study ID #: CTU104-PC-014
• Status: Completed
• Phase: N/A
• Start date: September 2015
• Est. completion date: March 2016

Study information

• Verified date: July 2019
• Source: Central Taiwan University of Science and Technology
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 123
• Est. completion date: March 2016
• Est. primary completion date: March 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 60 Years and older

Eligibility

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).

Related Conditions & MeSH terms

• Obesity
• Sarcopenia

Intervention

Behavioral:
• Resistant Training

Other:
• Control Group

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Central Taiwan University of Science and Technology

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Body Composition	measuring machine: Bioelectrical impedance analysis (BIA) estimates body composition of fat and lean tissue.	Change gram, kg and percentage from baseline to follow up (12 weeks later)
Primary	body weight	Weighing scales in kilograms	Change kg from baseline to follow up (12 weeks later)
Primary	BMI	kg/m2	Change from baseline to follow up (12 weeks later)
Primary	hand grip	Jamar Handgrip Dynamometer	Change from baseline to follow up (12 weeks later)
Primary	hand pinch	Lafayette Hydraulic Pinch Gauge 5030P1	Change kg from baseline to follow up (12 weeks later)
Primary	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.	Change score from baseline to follow up (12 weeks later)
Primary	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)	Change score from baseline to follow up (12 weeks later)