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

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.

Study Overview

• Status: Completed
• Conditions: Stroke; Cancer; Chronic Kidney Diseases; Osteoporosis
• Intervention / Treatment: Behavioral: elastic band strengthening exercise; Dietary supplement: diet counseling

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 Type: Interventional
• Enrollment (Actual): 186
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Taiwan
  • Changhua, Taiwan, 500
    • Changhua Christian Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: ADULT; OLDER_ADULT; CHILD
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

• 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 Plan

How is the study designed?

Design Details

• Primary Purpose: PREVENTION
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: DOUBLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
ACTIVE_COMPARATOR: exercise group; elastic band strengthening exercise	Behavioral: elastic band strengthening exercise; 2-3days per week(150min per week); Other Names: thera-band strengthening exercise
EXPERIMENTAL: exercise combine diet counseling group; elastic band strengthening exercise combined diet counseling.	Behavioral: elastic band strengthening exercise; 2-3days per week(150min per week); Other Names: thera-band strengthening exercise; Dietary supplement: diet counseling; each patients in this group will receive4-5times diet counseling; Other Names: nutrition counseling

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change of walking speed	distance: 6m, patients can walk with foor orthosis and assistive devices	baseline: before intervention; follow-up: 3 months after intervention
Change of grip force	Use a grip force meter (kg) to test both hands for test 3 times	before intervention; follow-up: 3 months after intervention
Change of postural sway displacement	Use computerized dynography to measure the postural sway displacement (mm)	before intervention; follow-up: 3 months after intervention
Change of postural sway velocity	Use computerized dynography to measure the postural sway velocity (mm/s)	before intervention; follow-up: 3 months after intervention
Change of postural sway area	Use computerized dynography to measure the postural sway area (mm^2)	before intervention; follow-up: 3 months after intervention
Change of step time	Use computerized dynography to measure spatial gait parameter: step time (ms)	before intervention; follow-up: 3 months after intervention
Change of stance time	Use computerized dynography to measure spatial gait parameter: stance time (ms)	before intervention; follow-up: 3 months after intervention
Change of swing time	Use computerized dynography to measure spatial gait parameter: swing time (ms)	before intervention; follow-up: 3 months after intervention
Change of single support time	Use computerized dynography to measure spatial gait parameter: single support time (ms)	before intervention; follow-up: 3 months after intervention
Change of double support time	Use computerized dynography to measure spatial gait parameter: double support time (ms)	before intervention; follow-up: 3 months after intervention
Change of step length	Use computerized dynography to measure spatial gait parameter: step distance (mm)	before intervention; follow-up: 3 months after intervention
Change of stance length	Use computerized dynography to measure spatial gait parameter: stance distance (mm)	before intervention; follow-up: 3 months after intervention
Change of muscle thickness	Use ultrasound to assess muscles morphological parameter: thickness (mm). Target muscles include quadriceps, hamstring, anterior tibialis, gastrocnemius.	before intervention; follow-up: 3 months after intervention
Change of muscle fiber length	Use ultrasound to assess muscles morphological parameter: fiber length (mm). Target muscles include quadriceps, hamstring, anterior tibialis, gastrocnemius.	before intervention; follow-up: 3 months after intervention
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.	before intervention; follow-up: 3 months after intervention
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.	before intervention; follow-up: 3 months after intervention
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)	before intervention; follow-up: 3 months after intervention
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.	before intervention; follow-up: 3 months after intervention
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.	before intervention; follow-up: 3 months after intervention

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	before intervention; follow-up: 3 months after intervention
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.	before intervention; follow-up: 3 months after intervention
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.	before intervention; follow-up: 3 months after intervention
Change of concentration of Hemoglobin (Hb)	The concentration of Hb in the blood test.	Time Frame: before intervention; follow-up: 3 months after intervention
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	Time Frame: before intervention; follow-up: 3 months after intervention
Change of concentration of Cholesterol	The concentration of Cholesterol in the blood test.	before intervention; follow-up: 3 months after intervention
Change of concentration of Triglyceride	The concentration of Triglyceride in the blood test.	before intervention; follow-up: 3 months after intervention
Change of concentration of Transferrin	The concentration of Transferrin in the blood test.	before intervention; follow-up: 3 months after intervention
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	before intervention; follow-up: 3 months after intervention
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)	before intervention; follow-up: 3 months after intervention
Change of Body Mass Index (BMI)	(body weight) kg/(height) m*(height)m	before intervention; follow-up: 3 months after intervention
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.	before intervention; follow-up: 3 months after intervention
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	before intervention; follow-up: 3 months after intervention
Change of Muscle tone	measure the muscle tone (kg/m) under muscle resting. Target muscles are quadricep, hamstring, anterior tibialis, gastrocnemius.	before intervention; follow-up: 3 months after intervention

Collaborators and Investigators

• Sponsor: Changhua Christian Hospital
• Investigators: Study Director: Tasen Wei, Doctor, Changhua Christian Hospital

Publications and helpful links

General Publications

• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (ACTUAL): February 1, 2019
• Primary Completion (ACTUAL): September 30, 2022
• Study Completion (ACTUAL): September 30, 2022

Study Registration Dates

• First Submitted: December 28, 2018
• First Submitted That Met QC Criteria: January 9, 2019
• First Posted (ACTUAL): January 10, 2019

Study Record Updates

• Last Update Posted (ACTUAL): November 1, 2022
• Last Update Submitted That Met QC Criteria: October 30, 2022
• Last Verified: October 1, 2022

More Information

Terms related to this study

• Keywords: stroke; cancer; chronic kidney disease; osteoporosis; Sarcopenia; fall; balance and gait
• Additional Relevant MeSH Terms: Pathologic Processes; Metabolic Diseases; Nervous System Diseases; Urologic Diseases; Neurologic Manifestations; Disease Attributes; Renal Insufficiency; Musculoskeletal Diseases; Neuromuscular Manifestations; Pathological Conditions, Anatomical; Bone Diseases; Muscular Atrophy; Atrophy; Bone Diseases, Metabolic; Kidney Diseases; Renal Insufficiency, Chronic; Chronic Disease; Sarcopenia; Osteoporosis
• Other Study ID Numbers: CCH-170208

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: only for research

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No