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OpenTrials
Completed

NCT Number: NCT02912338

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

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.

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Key information

Conditions

Sarcopenia Atrophy Body Weight Muscular Atrophy Nervous System Diseases Neurologic Manifestations Neuromuscular Manifestations Nutrition Disorders Nutritional and Metabolic Diseases Obesity Overnutrition Overweight Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

60 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

Resistant Training

Behavioral

Control Group

Other

Primary outcomes

  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)

Sponsors and collaborators

Lead sponsor

Central Taiwan University of Science and Technology

Other

Registry information

Important dates

Study start
2015
Primary completion
2016
Study completion
2016
First posted
Sep 23, 2016
Registry last updated
Jul 22, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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