Sarcopenia and Risk of Falls in Patients With Major Chronic Diseases
Primary Purpose
Stroke, Osteoporosis, Chronic Kidney Diseases
Status
Completed
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
elastic band strengthening exercise
diet counseling
Sponsored by
About this trial
This is an interventional prevention trial for Stroke focused on measuring Sarcopenia, stroke, osteoporosis, chronic kidney disease, cancer, balance and gait, fall
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
Sites / Locations
- Changhua Christian Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
exercise group
exercise combine diet counseling group
Arm Description
elastic band strengthening exercise
elastic band strengthening exercise combined diet counseling.
Outcomes
Primary Outcome Measures
Change of walking speed
distance: 6m, patients can walk with foor orthosis and assistive devices
Change of grip force
Use a grip force meter (kg) to test both hands for test 3 times
Change of postural sway displacement
Use computerized dynography to measure the postural sway displacement (mm)
Change of postural sway velocity
Use computerized dynography to measure the postural sway velocity (mm/s)
Change of postural sway area
Use computerized dynography to measure the postural sway area (mm^2)
Change of step time
Use computerized dynography to measure spatial gait parameter: step time (ms)
Change of stance time
Use computerized dynography to measure spatial gait parameter: stance time (ms)
Change of swing time
Use computerized dynography to measure spatial gait parameter: swing time (ms)
Change of single support time
Use computerized dynography to measure spatial gait parameter: single support time (ms)
Change of double support time
Use computerized dynography to measure spatial gait parameter: double support time (ms)
Change of step length
Use computerized dynography to measure spatial gait parameter: step distance (mm)
Change of stance length
Use computerized dynography to measure spatial gait parameter: stance distance (mm)
Change of muscle thickness
Use ultrasound to assess muscles morphological parameter: thickness (mm). Target muscles include quadriceps, hamstring, anterior tibialis, gastrocnemius.
Change of muscle fiber length
Use ultrasound to assess muscles morphological parameter: fiber length (mm). Target muscles include quadriceps, hamstring, anterior tibialis, gastrocnemius.
Change of muscle fiber orientation angle
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
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)
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 international Quality of Life Assessment Short Form -36 (SF-36)
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 amplitude of Muscle activity
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 Outcome Measures
Change of concentration of CRP (C-Reactive Protein)
The concentration of CRP in the blood test. CRP is used mainly as a marker of inflammation.
Change of concentration of ALB (Serum albumin)
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 concentration of Glomerular Filtration Rate (GFR)
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)
The concentration of Hb in the blood test.
Change of concentration of Glucose SPOT
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
The concentration of Cholesterol in the blood test.
Change of concentration of Triglyceride
The concentration of Triglyceride in the blood test.
Change of concentration of Transferrin
The concentration of Transferrin in the blood test.
Change of Berg balance test (BBS)
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 Fugl-Meyer Assessment (FMA)
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 Body Mass Index (BMI)
(body weight) kg/(height) m*(height)m
Change of Mini-mental state examination (MMSE)
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 Modified Ashworth scale (MAS)
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
Change of Muscle tone
measure the muscle tone (kg/m) under muscle resting. Target muscles are quadricep, hamstring, anterior tibialis, gastrocnemius.
Full Information
NCT ID
NCT03798418
First Posted
December 28, 2018
Last Updated
October 30, 2022
Sponsor
Changhua Christian Hospital
1. Study Identification
Unique Protocol Identification Number
NCT03798418
Brief Title
Sarcopenia and Risk of Falls in Patients With Major Chronic Diseases
Official Title
Sarcopenia and Risk of Falls in Patients With Major Chronic Diseases - Effects of Therapeutic Exercise and Nutrition Intervention
Study Type
Interventional
2. Study Status
Record Verification Date
October 2022
Overall Recruitment Status
Completed
Study Start Date
February 1, 2019 (Actual)
Primary Completion Date
September 30, 2022 (Actual)
Study Completion Date
September 30, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Changhua Christian Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke, Osteoporosis, Chronic Kidney Diseases, Cancer
Keywords
Sarcopenia, stroke, osteoporosis, chronic kidney disease, cancer, balance and gait, fall
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
186 (Actual)
8. Arms, Groups, and Interventions
Arm Title
exercise group
Arm Type
Active Comparator
Arm Description
elastic band strengthening exercise
Arm Title
exercise combine diet counseling group
Arm Type
Experimental
Arm Description
elastic band strengthening exercise combined diet counseling.
Intervention Type
Behavioral
Intervention Name(s)
elastic band strengthening exercise
Other Intervention Name(s)
thera-band strengthening exercise
Intervention Description
2-3days per week(150min per week)
Intervention Type
Dietary Supplement
Intervention Name(s)
diet counseling
Other Intervention Name(s)
nutrition counseling
Intervention Description
each patients in this group will receive4-5times diet counseling
Primary Outcome Measure Information:
Title
Change of walking speed
Description
distance: 6m, patients can walk with foor orthosis and assistive devices
Time Frame
baseline: before intervention; follow-up: 3 months after intervention
Title
Change of grip force
Description
Use a grip force meter (kg) to test both hands for test 3 times
Time Frame
before intervention; follow-up: 3 months after intervention
Title
Change of postural sway displacement
Description
Use computerized dynography to measure the postural sway displacement (mm)
Time Frame
before intervention; follow-up: 3 months after intervention
Title
Change of postural sway velocity
Description
Use computerized dynography to measure the postural sway velocity (mm/s)
Time Frame
before intervention; follow-up: 3 months after intervention
Title
Change of postural sway area
Description
Use computerized dynography to measure the postural sway area (mm^2)
Time Frame
before intervention; follow-up: 3 months after intervention
Title
Change of step time
Description
Use computerized dynography to measure spatial gait parameter: step time (ms)
Time Frame
before intervention; follow-up: 3 months after intervention
Title
Change of stance time
Description
Use computerized dynography to measure spatial gait parameter: stance time (ms)
Time Frame
before intervention; follow-up: 3 months after intervention
Title
Change of swing time
Description
Use computerized dynography to measure spatial gait parameter: swing time (ms)
Time Frame
before intervention; follow-up: 3 months after intervention
Title
Change of single support time
Description
Use computerized dynography to measure spatial gait parameter: single support time (ms)
Time Frame
before intervention; follow-up: 3 months after intervention
Title
Change of double support time
Description
Use computerized dynography to measure spatial gait parameter: double support time (ms)
Time Frame
before intervention; follow-up: 3 months after intervention
Title
Change of step length
Description
Use computerized dynography to measure spatial gait parameter: step distance (mm)
Time Frame
before intervention; follow-up: 3 months after intervention
Title
Change of stance length
Description
Use computerized dynography to measure spatial gait parameter: stance distance (mm)
Time Frame
before intervention; follow-up: 3 months after intervention
Title
Change of muscle thickness
Description
Use ultrasound to assess muscles morphological parameter: thickness (mm). Target muscles include quadriceps, hamstring, anterior tibialis, gastrocnemius.
Time Frame
before intervention; follow-up: 3 months after intervention
Title
Change of muscle fiber length
Description
Use ultrasound to assess muscles morphological parameter: fiber length (mm). Target muscles include quadriceps, hamstring, anterior tibialis, gastrocnemius.
Time Frame
before intervention; follow-up: 3 months after intervention
Title
Change of muscle fiber orientation angle
Description
Use ultrasound to assess muscles morphological parameter: fiber orientation angle (degrees). Target muscles include quadriceps, hamstring, anterior tibialis, gastrocnemius.
Time Frame
before intervention; follow-up: 3 months after intervention
Title
Change of muscle cross section area
Description
Use ultrasound to assess muscles morphological parameter: cross-sectional area (mm^2).
Target muscles include quadriceps, hamstring, anterior tibialis, gastrocnemius.
Time Frame
before intervention; follow-up: 3 months after intervention
Title
Change of physiological cost index (PCI)
Description
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)
Time Frame
before intervention; follow-up: 3 months after intervention
Title
Change of international Quality of Life Assessment Short Form -36 (SF-36)
Description
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.
Time Frame
before intervention; follow-up: 3 months after intervention
Title
Change of amplitude of Muscle activity
Description
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.
Time Frame
before intervention; follow-up: 3 months after intervention
Secondary Outcome Measure Information:
Title
Change of concentration of CRP (C-Reactive Protein)
Description
The concentration of CRP in the blood test. CRP is used mainly as a marker of inflammation.
Time Frame
before intervention; follow-up: 3 months after intervention
Title
Change of concentration of ALB (Serum albumin)
Description
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.
Time Frame
before intervention; follow-up: 3 months after intervention
Title
Change of concentration of Glomerular Filtration Rate (GFR)
Description
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.
Time Frame
before intervention; follow-up: 3 months after intervention
Title
Change of concentration of Hemoglobin (Hb)
Description
The concentration of Hb in the blood test.
Time Frame
Time Frame: before intervention; follow-up: 3 months after intervention
Title
Change of concentration of Glucose SPOT
Description
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
Time Frame
Time Frame: before intervention; follow-up: 3 months after intervention
Title
Change of concentration of Cholesterol
Description
The concentration of Cholesterol in the blood test.
Time Frame
before intervention; follow-up: 3 months after intervention
Title
Change of concentration of Triglyceride
Description
The concentration of Triglyceride in the blood test.
Time Frame
before intervention; follow-up: 3 months after intervention
Title
Change of concentration of Transferrin
Description
The concentration of Transferrin in the blood test.
Time Frame
before intervention; follow-up: 3 months after intervention
Title
Change of Berg balance test (BBS)
Description
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
Time Frame
before intervention; follow-up: 3 months after intervention
Title
Change of Fugl-Meyer Assessment (FMA)
Description
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)
Time Frame
before intervention; follow-up: 3 months after intervention
Title
Change of Body Mass Index (BMI)
Description
(body weight) kg/(height) m*(height)m
Time Frame
before intervention; follow-up: 3 months after intervention
Title
Change of Mini-mental state examination (MMSE)
Description
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.
Time Frame
before intervention; follow-up: 3 months after intervention
Title
Change of Modified Ashworth scale (MAS)
Description
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
Time Frame
before intervention; follow-up: 3 months after intervention
Title
Change of Muscle tone
Description
measure the muscle tone (kg/m) under muscle resting. Target muscles are quadricep, hamstring, anterior tibialis, gastrocnemius.
Time Frame
before intervention; follow-up: 3 months after intervention
10. Eligibility
Sex
All
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Tasen Wei, Doctor
Organizational Affiliation
Changhua Christian Hospital
Official's Role
Study Director
Facility Information:
Facility Name
Changhua Christian Hospital
City
Changhua
ZIP/Postal Code
500
Country
Taiwan
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
only for research
Citations:
PubMed Identifier
24785098
Citation
Biolo G, Cederholm T, Muscaritoli M. Muscle contractile and metabolic dysfunction is a common feature of sarcopenia of aging and chronic diseases: from sarcopenic obesity to cachexia. Clin Nutr. 2014 Oct;33(5):737-48. doi: 10.1016/j.clnu.2014.03.007. Epub 2014 Mar 29.
Results Reference
background
PubMed Identifier
11518445
Citation
Stapleton T, Ashburn A, Stack E. A pilot study of attention deficits, balance control and falls in the subacute stage following stroke. Clin Rehabil. 2001 Aug;15(4):437-44. doi: 10.1191/026921501678310243.
Results Reference
background
PubMed Identifier
11833018
Citation
Hyndman D, Ashburn A, Stack E. Fall events among people with stroke living in the community: circumstances of falls and characteristics of fallers. Arch Phys Med Rehabil. 2002 Feb;83(2):165-70. doi: 10.1053/apmr.2002.28030.
Results Reference
background
PubMed Identifier
25852886
Citation
Kutner NG, Zhang R, Huang Y, Wasse H. Falls among hemodialysis patients: potential opportunities for prevention? Clin Kidney J. 2014 Jun;7(3):257-63. doi: 10.1093/ckj/sfu034. Epub 2014 Apr 15.
Results Reference
background
PubMed Identifier
17699348
Citation
Cook WL, Tomlinson G, Donaldson M, Markowitz SN, Naglie G, Sobolev B, Jassal SV. Falls and fall-related injuries in older dialysis patients. Clin J Am Soc Nephrol. 2006 Nov;1(6):1197-204. doi: 10.2215/CJN.01650506. Epub 2006 Aug 30.
Results Reference
background
PubMed Identifier
24415363
Citation
Couch ME, Dittus K, Toth MJ, Willis MS, Guttridge DC, George JR, Barnes CA, Gourin CG, Der-Torossian H. Cancer cachexia update in head and neck cancer: Definitions and diagnostic features. Head Neck. 2015 Apr;37(4):594-604. doi: 10.1002/hed.23599. Epub 2014 Mar 25.
Results Reference
background
PubMed Identifier
19588334
Citation
Liu CJ, Latham NK. Progressive resistance strength training for improving physical function in older adults. Cochrane Database Syst Rev. 2009 Jul 8;2009(3):CD002759. doi: 10.1002/14651858.CD002759.pub2.
Results Reference
background
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Sarcopenia and Risk of Falls in Patients With Major Chronic Diseases
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