NCT02912338

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
123

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Sep 2015

Shorter than P25 for not_applicable

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2015

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2016

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

September 9, 2016

Completed
14 days until next milestone

First Posted

Study publicly available on registry

September 23, 2016

Completed
Last Updated

July 22, 2019

Status Verified

July 1, 2019

Enrollment Period

6 months

First QC Date

September 9, 2016

Last Update Submit

July 18, 2019

Conditions

Keywords

Sarcopenic obesityBody compositionPhysical functionquality of lifelong term care

Outcome Measures

Primary Outcomes (7)

  • 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)

  • body weight

    Weighing scales in kilograms

    Change kg from baseline to follow up (12 weeks later)

  • BMI

    kg/m2

    Change from baseline to follow up (12 weeks later)

  • hand grip

    Jamar Handgrip Dynamometer

    Change from baseline to follow up (12 weeks later)

  • hand pinch

    Lafayette Hydraulic Pinch Gauge 5030P1

    Change kg from baseline to follow up (12 weeks later)

  • 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)

  • 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)

Study Arms (2)

Resistant Training Group

EXPERIMENTAL

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

Behavioral: Resistant Training

Control Group

ACTIVE COMPARATOR

not change lifestyle

Other: Control Group

Interventions

Resistant Training Group
Control Group

Eligibility Criteria

Age60 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (2)

  • 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.

  • 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.

MeSH Terms

Conditions

SarcopeniaObesity

Interventions

Control Groups

Condition Hierarchy (Ancestors)

Muscular AtrophyNeuromuscular ManifestationsNeurologic ManifestationsNervous System DiseasesAtrophyPathological Conditions, AnatomicalPathological Conditions, Signs and SymptomsSigns and SymptomsOverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody Weight

Intervention Hierarchy (Ancestors)

Epidemiologic Research DesignEpidemiologic MethodsInvestigative TechniquesResearch DesignMethods

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Senior Lecturer, PhD candidate

Study Record Dates

First Submitted

September 9, 2016

First Posted

September 23, 2016

Study Start

September 1, 2015

Primary Completion

March 1, 2016

Study Completion

March 1, 2016

Last Updated

July 22, 2019

Record last verified: 2019-07