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

July 18, 2019 updated by: Chiu Shu-Ching, Central Taiwan University of Science and Technology
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

123

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

60 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: SUPPORTIVE_CARE
  • Allocation: NON_RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Change gram, kg and percentage from baseline to follow up (12 weeks later)
body weight
Time Frame: Change kg from baseline to follow up (12 weeks later)
Weighing scales in kilograms
Change kg from baseline to follow up (12 weeks later)
BMI
Time Frame: Change from baseline to follow up (12 weeks later)
kg/m2
Change from baseline to follow up (12 weeks later)
hand grip
Time Frame: Change from baseline to follow up (12 weeks later)
Jamar Handgrip Dynamometer
Change from baseline to follow up (12 weeks later)
hand pinch
Time Frame: Change kg from baseline to follow up (12 weeks later)
Lafayette Hydraulic Pinch Gauge 5030P1
Change kg from baseline to follow up (12 weeks later)
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.
Change score from baseline to follow up (12 weeks later)
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)
Change score from baseline to follow up (12 weeks later)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Central Taiwan University of Science and Technology

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2015

Primary Completion (Actual)

March 1, 2016

Study Completion (Actual)

March 1, 2016

Study Registration Dates

First Submitted

September 9, 2016

First Submitted That Met QC Criteria

September 21, 2016

First Posted (Estimate)

September 23, 2016

Study Record Updates

Last Update Posted (Actual)

July 22, 2019

Last Update Submitted That Met QC Criteria

July 18, 2019

Last Verified

July 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CTU104-PC-014

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Subscribe