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Clinical Trials/NCT03798418
NCT03798418
Completed
Not Applicable

Sarcopenia and Risk of Falls in Patients With Major Chronic Diseases - Effects of Therapeutic Exercise and Nutrition Intervention

Changhua Christian Hospital1 site in 1 country186 target enrollmentFebruary 1, 2019

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Stroke
Sponsor
Changhua Christian Hospital
Enrollment
186
Locations
1
Primary Endpoint
Change of grip force
Status
Completed
Last Updated
3 years ago

Overview

Brief Summary

The objective of this study is to investigate the effects of therapeutic exercise and nutrition intervention for sarcopenia and risk of falls in patients with major chronic diseases. The outcomes will be analyzed regarding muscle strength, quality, and volume, etc., balance and gait, bone density, body composition, fall and quality of life after the intervention.

Detailed Description

The main common chronic diseases in the elderly such as stroke, osteoporosis, chronic kidney disease and cancer, have been regarded as the fall high-risk patients. These patients are considered to be at risk for sarcopenia due to decreased exercise, nutritional status, and other reasons. Sarcopenia can be diagnosed and intervened effectively to delay the vicious cycle of health. Past studies have pointed out that in addition to drug intervention, treatment for sarcopenia must be accompanied by appropriate exercise and nutritional intervention (such as protein supplements, vitamin D) in order to achieve the best prevention and treatment.

Registry
clinicaltrials.gov
Start Date
February 1, 2019
End Date
September 30, 2022
Last Updated
3 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Ta-Sen Wei,MD

Director, Physical Medical and Rehabilitation, Principal Investigator, Clinical Professor

Changhua Christian Hospital

Eligibility Criteria

Inclusion Criteria

  • 55-85 years old
  • 3-6 months after onset
  • walk independently for at least 10m

Exclusion Criteria

  • lower limb Brunnstrom stage \>5
  • combine other neuropathy diseases
  • significant deformity of lower limb include: Modified Ashworth scale(MAS) \>3; contracture, fracture, chronic joint pain.
  • joint arthroplasty
  • unstable vital sign
  • can not cooperate study

Outcomes

Primary Outcomes

Change of grip force

Time Frame: before intervention; follow-up: 3 months after intervention

Use a grip force meter (kg) to test both hands for test 3 times

Change of postural sway velocity

Time Frame: before intervention; follow-up: 3 months after intervention

Use computerized dynography to measure the postural sway velocity (mm/s)

Change of swing time

Time Frame: before intervention; follow-up: 3 months after intervention

Use computerized dynography to measure spatial gait parameter: swing time (ms)

Change of single support time

Time Frame: before intervention; follow-up: 3 months after intervention

Use computerized dynography to measure spatial gait parameter: single support time (ms)

Change of double support time

Time Frame: before intervention; follow-up: 3 months after intervention

Use computerized dynography to measure spatial gait parameter: double support time (ms)

Change of postural sway displacement

Time Frame: before intervention; follow-up: 3 months after intervention

Use computerized dynography to measure the postural sway displacement (mm)

Change of postural sway area

Time Frame: before intervention; follow-up: 3 months after intervention

Use computerized dynography to measure the postural sway area (mm\^2)

Change of muscle thickness

Time Frame: before intervention; follow-up: 3 months after intervention

Use ultrasound to assess muscles morphological parameter: thickness (mm). Target muscles include quadriceps, hamstring, anterior tibialis, gastrocnemius.

Change of international Quality of Life Assessment Short Form -36 (SF-36)

Time Frame: before intervention; follow-up: 3 months after intervention

including 8 health concepts: (1) physical functioning, (2) role limitations because of physical health problems; (3) bodily pain, (4) social functioning, (5) general mental health (psychological distress and psychological wellbeing), (6) role limitations because of emotional problems, (7) vitality (energy/fatigue), (8) general health perceptions. Scoring: answers to each question are scored which are then summed and transformed to a 0 - 100 scale. The lower the score the more disability. The higher the score the less disability i.e., a score of zero is equivalent to maximum disability and a score of 100 is equivalent to no disability.

Change of step time

Time Frame: before intervention; follow-up: 3 months after intervention

Use computerized dynography to measure spatial gait parameter: step time (ms)

Change of amplitude of Muscle activity

Time Frame: before intervention; follow-up: 3 months after intervention

use electromyography to measure the muscles activity in microvolts (uv) included quadriceps, hamstrings, tibialis anterior, gastrocnemius during subject walking in self-selected speed in 6 meters.

Change of muscle fiber length

Time Frame: before intervention; follow-up: 3 months after intervention

Use ultrasound to assess muscles morphological parameter: fiber length (mm). Target muscles include quadriceps, hamstring, anterior tibialis, gastrocnemius.

Change of muscle fiber orientation angle

Time Frame: before intervention; follow-up: 3 months after intervention

Use ultrasound to assess muscles morphological parameter: fiber orientation angle (degrees). Target muscles include quadriceps, hamstring, anterior tibialis, gastrocnemius.

Change of muscle cross section area

Time Frame: before intervention; follow-up: 3 months after intervention

Use ultrasound to assess muscles morphological parameter: cross-sectional area (mm\^2). Target muscles include quadriceps, hamstring, anterior tibialis, gastrocnemius.

Change of physiological cost index (PCI)

Time Frame: before intervention; follow-up: 3 months after intervention

Heart rate (HR: beats/min) and walking speed (m/s) have been previously shown to be linearly related to oxygen uptake at sub-maximal exercise levels. Combination of these two parameters yields a single value in beats per meter, the physiological cost index (PCI). This is calculated as Working HR - Resting HR (beats/min) / Walking speed (m/s)

Change of walking speed

Time Frame: baseline: before intervention; follow-up: 3 months after intervention

distance: 6m, patients can walk with foor orthosis and assistive devices

Change of step length

Time Frame: before intervention; follow-up: 3 months after intervention

Use computerized dynography to measure spatial gait parameter: step distance (mm)

Change of stance length

Time Frame: before intervention; follow-up: 3 months after intervention

Use computerized dynography to measure spatial gait parameter: stance distance (mm)

Change of stance time

Time Frame: before intervention; follow-up: 3 months after intervention

Use computerized dynography to measure spatial gait parameter: stance time (ms)

Secondary Outcomes

  • Change of concentration of CRP (C-Reactive Protein)(before intervention; follow-up: 3 months after intervention)
  • Change of concentration of ALB (Serum albumin)(before intervention; follow-up: 3 months after intervention)
  • Change of Fugl-Meyer Assessment (FMA)(before intervention; follow-up: 3 months after intervention)
  • Change of concentration of Glomerular Filtration Rate (GFR)(before intervention; follow-up: 3 months after intervention)
  • Change of concentration of Hemoglobin (Hb)(Time Frame: before intervention; follow-up: 3 months after intervention)
  • Change of concentration of Glucose SPOT(Time Frame: before intervention; follow-up: 3 months after intervention)
  • Change of concentration of Cholesterol(before intervention; follow-up: 3 months after intervention)
  • Change of concentration of Transferrin(before intervention; follow-up: 3 months after intervention)
  • Change of concentration of Triglyceride(before intervention; follow-up: 3 months after intervention)
  • Change of Body Mass Index (BMI)(before intervention; follow-up: 3 months after intervention)
  • Change of Mini-mental state examination (MMSE)(before intervention; follow-up: 3 months after intervention)
  • Change of Berg balance test (BBS)(before intervention; follow-up: 3 months after intervention)
  • Change of Modified Ashworth scale (MAS)(before intervention; follow-up: 3 months after intervention)
  • Change of Muscle tone(before intervention; follow-up: 3 months after intervention)

Study Sites (1)

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