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Sarcopenia and Risk of Falls in Patients With Major Chronic Diseases

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03798418
Enrollment
186
Registered
2019-01-10
Start date
2019-02-01
Completion date
2022-09-30
Last updated
2022-11-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Stroke, Osteoporosis, Chronic Kidney Diseases, Cancer

Keywords

Sarcopenia, stroke, osteoporosis, chronic kidney disease, cancer, balance and gait, fall

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.

Interventions

BEHAVIORALelastic band strengthening exercise

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

DIETARY_SUPPLEMENTdiet counseling

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

Sponsors

Changhua Christian Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Healthy volunteers
No

Inclusion criteria

* Inclusion Criteria: 1. 55-85 years old 2. 3-6 months after onset 3. walk independently for at least 10m *

Exclusion criteria

1. lower limb Brunnstrom stage \>5 2. combine other neuropathy diseases 3. significant deformity of lower limb include: Modified Ashworth scale(MAS) \>3; contracture, fracture, chronic joint pain. 4. joint arthroplasty 5. unstable vital sign 6. can not cooperate study

Design outcomes

Primary

MeasureTime frameDescription
Change of amplitude of Muscle activitybefore intervention; follow-up: 3 months after interventionuse 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 postural sway areabefore intervention; follow-up: 3 months after interventionUse computerized dynography to measure the postural sway area (mm\^2)
Change of step timebefore intervention; follow-up: 3 months after interventionUse computerized dynography to measure spatial gait parameter: step time (ms)
Change of stance timebefore intervention; follow-up: 3 months after interventionUse computerized dynography to measure spatial gait parameter: stance time (ms)
Change of swing timebefore intervention; follow-up: 3 months after interventionUse computerized dynography to measure spatial gait parameter: swing time (ms)
Change of single support timebefore intervention; follow-up: 3 months after interventionUse computerized dynography to measure spatial gait parameter: single support time (ms)
Change of double support timebefore intervention; follow-up: 3 months after interventionUse computerized dynography to measure spatial gait parameter: double support time (ms)
Change of step lengthbefore intervention; follow-up: 3 months after interventionUse computerized dynography to measure spatial gait parameter: step distance (mm)
Change of stance lengthbefore intervention; follow-up: 3 months after interventionUse computerized dynography to measure spatial gait parameter: stance distance (mm)
Change of muscle thicknessbefore intervention; follow-up: 3 months after interventionUse ultrasound to assess muscles morphological parameter: thickness (mm). Target muscles include quadriceps, hamstring, anterior tibialis, gastrocnemius.
Change of muscle fiber lengthbefore intervention; follow-up: 3 months after interventionUse ultrasound to assess muscles morphological parameter: fiber length (mm). Target muscles include quadriceps, hamstring, anterior tibialis, gastrocnemius.
Change of muscle fiber orientation anglebefore intervention; follow-up: 3 months after interventionUse ultrasound to assess muscles morphological parameter: fiber orientation angle (degrees). Target muscles include quadriceps, hamstring, anterior tibialis, gastrocnemius.
Change of muscle cross section areabefore intervention; follow-up: 3 months after interventionUse 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)before intervention; follow-up: 3 months after interventionHeart 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 international Quality of Life Assessment Short Form -36 (SF-36)before intervention; follow-up: 3 months after interventionincluding 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 walking speedbaseline: before intervention; follow-up: 3 months after interventiondistance: 6m, patients can walk with foor orthosis and assistive devices
Change of grip forcebefore intervention; follow-up: 3 months after interventionUse a grip force meter (kg) to test both hands for test 3 times
Change of postural sway displacementbefore intervention; follow-up: 3 months after interventionUse computerized dynography to measure the postural sway displacement (mm)
Change of postural sway velocitybefore intervention; follow-up: 3 months after interventionUse computerized dynography to measure the postural sway velocity (mm/s)

Secondary

MeasureTime frameDescription
Change of concentration of ALB (Serum albumin)before intervention; follow-up: 3 months after interventionThe 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.
Change of concentration of Glomerular Filtration Rate (GFR)before intervention; follow-up: 3 months after interventionThe 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.
Change of concentration of Hemoglobin (Hb)Time Frame: before intervention; follow-up: 3 months after interventionThe concentration of Hb in the blood test.
Change of concentration of Glucose SPOTTime Frame: before intervention; follow-up: 3 months after interventionThe 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
Change of concentration of Cholesterolbefore intervention; follow-up: 3 months after interventionThe concentration of Cholesterol in the blood test.
Change of concentration of Triglyceridebefore intervention; follow-up: 3 months after interventionThe concentration of Triglyceride in the blood test.
Change of concentration of Transferrinbefore intervention; follow-up: 3 months after interventionThe concentration of Transferrin in the blood test.
Change of Berg balance test (BBS)before intervention; follow-up: 3 months after interventionincluding 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
Change of Fugl-Meyer Assessment (FMA)before intervention; follow-up: 3 months after interventionItems 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)
Change of Body Mass Index (BMI)before intervention; follow-up: 3 months after intervention(body weight) kg/(height) m\*(height)m
Change of Mini-mental state examination (MMSE)before intervention; follow-up: 3 months after interventionIt 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.
Change of Modified Ashworth scale (MAS)before intervention; follow-up: 3 months after interventionmeasures resistance during passive soft-tissue stretching, the score is ranged from 0-4 0: No increase in muscle tone 1. 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 2. More marked increase in muscle tone through most of the ROM, but affected part(s) easily moved 3. Considerable increase in muscle tone, passive movement difficult 4. Affected part(s) rigid in flexion or extension
Change of Muscle tonebefore intervention; follow-up: 3 months after interventionmeasure the muscle tone (kg/m) under muscle resting. Target muscles are quadricep, hamstring, anterior tibialis, gastrocnemius.
Change of concentration of CRP (C-Reactive Protein)before intervention; follow-up: 3 months after interventionThe concentration of CRP in the blood test. CRP is used mainly as a marker of inflammation.

Countries

Taiwan

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026