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Completed

NCT Number: NCT03798418

Sarcopenia and Risk of Falls in Patients With Major Chronic Diseases

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.

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: No

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

  • 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

Treatment and study plan

elastic band strengthening exercise

Behavioral

2-3days per week(150min per week)

Other names: thera-band strengthening exercise

diet counseling

Dietary Supplement

each patients in this group will receive4-5times diet counseling

Other names: nutrition counseling

Primary outcomes

  1. 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

  2. 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

  3. 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)

  4. 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)

  5. 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)

  6. 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)

  7. 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)

  8. 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)

  9. 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)

  10. 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)

  11. 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)

  12. 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)

  13. 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.

  14. 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.

  15. 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.

  16. 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.

  17. 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)

  18. 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.

  19. 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.

Secondary outcomes

  1. Change of concentration of CRP (C-Reactive Protein)

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

    The concentration of CRP in the blood test. CRP is used mainly as a marker of inflammation.

  2. Change of concentration of ALB (Serum albumin)

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

    The concentration of ALB in the blood test. Albumin is the most important contributor to the maintenance of plasma colloid oncotic pressure; deficiency results in edema.

  3. Change of concentration of Glomerular Filtration Rate (GFR)

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

    The concentration of GFR in the blood test. The glomerular filtration rate is the best test to measure the patient's level of kidney function and determine the stage of kidney disease. It can calculate it from the results of the blood creatinine test.

  4. Change of concentration of Hemoglobin (Hb)

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

    The concentration of Hb in the blood test.

  5. Change of concentration of Glucose SPOT

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

    The concentration of Glucose SPOT in the blood test. TheSpot glucose measurement in epidermal interstitial fluid appears to be a promising alternative to capillary blood glucose estimation

  6. Change of concentration of Cholesterol

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

    The concentration of Cholesterol in the blood test.

  7. Change of concentration of Triglyceride

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

    The concentration of Triglyceride in the blood test.

  8. Change of concentration of Transferrin

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

    The concentration of Transferrin in the blood test.

  9. Change of Berg balance test (BBS)

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

    including 14 items which are scored on a 5 points scale (0-4). The degree of success in achieving each task is given a score of zero (unable) to four (independent), and the final measure is the sum of all of the scores.

    The item scores are summed, minimum score =0, maximum score = 56

  10. Change of Fugl-Meyer Assessment (FMA)

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

    Items are scored on a 3-point ordinal scale (0 = cannot perform; 1 = performs partially; 2 = performs fully) Maximum Score = 226 points The 5 domains assessed include, Motor function (UE maximum score = 66; LE maximum score = 34), Sensory function (maximum score = 24), Balance (maximum score = 14), Joint range of motion (maximum score = 44), Joint pain (maximum score = 44)

  11. Change of Body Mass Index (BMI)

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

    (body weight) kg/(height) m*(height)m

  12. Change of Mini-mental state examination (MMSE)

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

    It is an 11-question measure that tests five areas of cognitive function:

    orientation, registration, attention and calculation, recall, and language. The maximum score is 30. A score of 23 or lower is indicative of cognitive impairment.

  13. Change of Modified Ashworth scale (MAS)

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

    measures resistance during passive soft-tissue stretching, the score is ranged from 0-4 0: No increase in muscle tone

    • Slight increase in muscle tone, manifested by a catch and release or by minimal resistance at the end of the range of motion when the affected part(s) is moved in flexion or extension 1+: Slight increase in muscle tone, manifested by a catch, followed by minimal resistance throughout the remainder (less than half) of the ROM
    • More marked increase in muscle tone through most of the ROM, but affected part(s) easily moved
    • Considerable increase in muscle tone, passive movement difficult
    • Affected part(s) rigid in flexion or extension
  14. Change of Muscle tone

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

    measure the muscle tone (kg/m) under muscle resting. Target muscles are quadricep, hamstring, anterior tibialis, gastrocnemius.

Sponsors and collaborators

Lead sponsor

Changhua Christian Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2022
Study completion
2022
First posted
Jan 10, 2019
Registry last updated
Nov 1, 2022

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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