Sarcopenia and Risk of Falls in Patients With Major Chronic Diseases

Not Applicable

Completed

• Conditions: Stroke; Cancer; Osteoporosis; Chronic Kidney Diseases
• Interventions: Behavioral: elastic band strengthening exercise; Dietary Supplement: diet counseling

• Registration Number: NCT03798418
• Lead Sponsor: Changhua Christian Hospital

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.

Study Timeline

• Study First Submitted: 2018-12-28
• Study First Submitted QC: 2019-01-09
• Study First Posted: 2019-01-10
• Study Start: 2019-02-01
• Primary Completion: 2022-09-30
• Study Completion: 2022-09-30
• Status Verified: 2022-10
• Last Update Submitted: 2022-10-30
• Last Update Posted: 2022-11-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 186

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
exercise combine diet counseling group	diet counseling	elastic band strengthening exercise combined diet counseling.
exercise combine diet counseling group	elastic band strengthening exercise	elastic band strengthening exercise combined diet counseling.
exercise group	elastic band strengthening exercise	elastic band strengthening exercise

Primary Outcome Measures

Name	Time	Method
Change of grip force	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	before intervention; follow-up: 3 months after intervention	Use computerized dynography to measure the postural sway velocity (mm/s)
Change of swing time	before intervention; follow-up: 3 months after intervention	Use computerized dynography to measure spatial gait parameter: swing time (ms)
Change of single support time	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	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	before intervention; follow-up: 3 months after intervention	Use computerized dynography to measure the postural sway displacement (mm)
Change of muscle thickness	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)	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	before intervention; follow-up: 3 months after intervention	Use computerized dynography to measure spatial gait parameter: step time (ms)
Change of postural sway area	before intervention; follow-up: 3 months after intervention	Use computerized dynography to measure the postural sway area (mm\^2)
Change of amplitude of Muscle activity	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	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	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	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)	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	baseline: before intervention; follow-up: 3 months after intervention	distance: 6m, patients can walk with foor orthosis and assistive devices
Change of step length	before intervention; follow-up: 3 months after intervention	Use computerized dynography to measure spatial gait parameter: step distance (mm)
Change of stance length	before intervention; follow-up: 3 months after intervention	Use computerized dynography to measure spatial gait parameter: stance distance (mm)
Change of stance time	before intervention; follow-up: 3 months after intervention	Use computerized dynography to measure spatial gait parameter: stance time (ms)

Secondary Outcome Measures

Name	Time	Method
Change of concentration of CRP (C-Reactive Protein)	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.
Change of concentration of ALB (Serum albumin)	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.
Change of Fugl-Meyer Assessment (FMA)	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)
Change of concentration of Glomerular Filtration Rate (GFR)	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.
Change of concentration of Hemoglobin (Hb)	Time Frame: before intervention; follow-up: 3 months after intervention	The concentration of Hb in the blood test.
Change of concentration of Glucose SPOT	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
Change of concentration of Cholesterol	before intervention; follow-up: 3 months after intervention	The concentration of Cholesterol in the blood test.
Change of concentration of Transferrin	before intervention; follow-up: 3 months after intervention	The concentration of Transferrin in the blood test.
Change of concentration of Triglyceride	before intervention; follow-up: 3 months after intervention	The concentration of Triglyceride in the blood test.
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 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.
Change of Berg balance test (BBS)	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
Change of Modified Ashworth scale (MAS)	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; 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 tone	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.

Trial Locations

Locations (1)

Changhua Christian Hospital; 🇨🇳 Changhua, Taiwan