Clinical trial NCT03798418: 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
Overall status: COMPLETED
Phase: NA
Conditions: Stroke
Osteoporosis
Chronic Kidney Diseases
Cancer
Keywords: Sarcopenia
stroke
osteoporosis
chronic kidney disease
cancer
balance and gait
fall
Lead sponsor: Changhua Christian Hospital
Sponsor class: OTHER
First posted: 2019-01-10
Enrollment: 186
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

Eligibility 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

Primary outcomes:
measure: Change of walking speed
timeFrame: baseline: before intervention; follow-up: 3 months after intervention
measure: Change of grip force
timeFrame: before intervention; follow-up: 3 months after intervention
measure: Change of postural sway displacement
timeFrame: before intervention; follow-up: 3 months after intervention
measure: Change of postural sway velocity
timeFrame: before intervention; follow-up: 3 months after intervention
measure: Change of postural sway area
timeFrame: before intervention; follow-up: 3 months after intervention
measure: Change of step time
timeFrame: before intervention; follow-up: 3 months after intervention
measure: Change of stance time
timeFrame: before intervention; follow-up: 3 months after intervention
measure: Change of swing time
timeFrame: before intervention; follow-up: 3 months after intervention
measure: Change of single support time
timeFrame: before intervention; follow-up: 3 months after intervention
measure: Change of double support time
timeFrame: before intervention; follow-up: 3 months after intervention
measure: Change of step length
timeFrame: before intervention; follow-up: 3 months after intervention
measure: Change of stance length
timeFrame: before intervention; follow-up: 3 months after intervention
measure: Change of muscle thickness
timeFrame: before intervention; follow-up: 3 months after intervention
measure: Change of muscle fiber length
timeFrame: before intervention; follow-up: 3 months after intervention
measure: Change of muscle fiber orientation angle
timeFrame: before intervention; follow-up: 3 months after intervention
measure: Change of muscle cross section area
timeFrame: before intervention; follow-up: 3 months after intervention
measure: Change of physiological cost index (PCI)
timeFrame: before intervention; follow-up: 3 months after intervention
measure: Change of international Quality of Life Assessment Short Form -36 (SF-36)
timeFrame: before intervention; follow-up: 3 months after intervention
measure: Change of amplitude of Muscle activity
timeFrame: before intervention; follow-up: 3 months after intervention
Secondary outcomes:
measure: Change of concentration of CRP (C-Reactive Protein)
timeFrame: before intervention; follow-up: 3 months after intervention
measure: Change of concentration of ALB (Serum albumin)
timeFrame: before intervention; follow-up: 3 months after intervention
measure: Change of concentration of Glomerular Filtration Rate (GFR)
timeFrame: before intervention; follow-up: 3 months after intervention
measure: Change of concentration of Hemoglobin (Hb)
timeFrame: Time Frame: before intervention; follow-up: 3 months after intervention
measure: Change of concentration of Glucose SPOT
timeFrame: Time Frame: before intervention; follow-up: 3 months after intervention
measure: Change of concentration of Cholesterol
timeFrame: before intervention; follow-up: 3 months after intervention
measure: Change of concentration of Triglyceride
timeFrame: before intervention; follow-up: 3 months after intervention
measure: Change of concentration of Transferrin
timeFrame: before intervention; follow-up: 3 months after intervention
measure: Change of Berg balance test (BBS)
timeFrame: before intervention; follow-up: 3 months after intervention
measure: Change of Fugl-Meyer Assessment (FMA)
timeFrame: before intervention; follow-up: 3 months after intervention
measure: Change of Body Mass Index (BMI)
timeFrame: before intervention; follow-up: 3 months after intervention
measure: Change of Mini-mental state examination (MMSE)
timeFrame: before intervention; follow-up: 3 months after intervention
measure: Change of Modified Ashworth scale (MAS)
timeFrame: before intervention; follow-up: 3 months after intervention
measure: Change of Muscle tone
timeFrame: before intervention; follow-up: 3 months after intervention
Other outcomes:
Locations:
city: Changhua
country: Taiwan
facility: Changhua Christian Hospital
Study officials:
affiliation: Changhua Christian Hospital
name: Tasen Wei, Doctor
role: STUDY_DIRECTOR
References:
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.
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.
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.
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.
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.
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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.