Sarcopenia and Risk of Falls in Patients With Major Chronic Diseases

NCT03798418 | Completed

• 1 other identifier: CCH-170208
• Study Type: interventional
• Target: 186
• Locations: 1 country
• Sites: 1

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.

Conditions

Stroke; Osteoporosis; Chronic Kidney Diseases; Cancer

Keywords

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

Outcome Measures

Primary Outcomes (19)

• 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 Outcomes (14)

• Change of concentration of CRP (C-Reactive Protein)

  before intervention; follow-up: 3 months after intervention

• Change of concentration of ALB (Serum albumin)

  before intervention; follow-up: 3 months after intervention

• Change of concentration of Glomerular Filtration Rate (GFR)

  before intervention; follow-up: 3 months after intervention

• Change of concentration of Hemoglobin (Hb)

  Time Frame: before intervention; follow-up: 3 months after intervention

• Change of concentration of Glucose SPOT

  Time Frame: before intervention; follow-up: 3 months after intervention

Study Arms (2)

exercise group

ACTIVE COMPARATOR

elastic band strengthening exercise

Behavioral: elastic band strengthening exercise

exercise combine diet counseling group

EXPERIMENTAL

elastic band strengthening exercise combined diet counseling.

Behavioral: elastic band strengthening exercise; Dietary Supplement: diet counseling

Interventions

elastic band strengthening exercise BEHAVIORAL

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

Also known as: thera-band strengthening exercise

exercise combine diet counseling group; exercise group

diet counseling DIETARY_SUPPLEMENT

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

Also known as: nutrition counseling

exercise combine diet counseling group

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• years old
• months after onset
• walk independently for at least 10m

You may not qualify if:

• 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

Sponsors & Collaborators

• Changhua Christian Hospital: lead

Study Sites (1)

Changhua Christian Hospital

Changhua, 500, Taiwan

Location

Related Publications (7)

• 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.

  PMID: 24785098 BACKGROUND

• 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.

  PMID: 11518445 BACKGROUND

• 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.

  PMID: 11833018 BACKGROUND

• 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.

  PMID: 25852886 BACKGROUND

• 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.

  PMID: 17699348 BACKGROUND

• 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.

  PMID: 24415363 BACKGROUND

• 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.

  PMID: 19588334 BACKGROUND

MeSH Terms

Conditions

Stroke; Osteoporosis; Renal Insufficiency, Chronic; Neoplasms; Sarcopenia

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Bone Diseases, Metabolic; Bone Diseases; Musculoskeletal Diseases; Metabolic Diseases; Nutritional and Metabolic Diseases; Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Muscular Atrophy; Neuromuscular Manifestations; Neurologic Manifestations; Atrophy; Pathological Conditions, Anatomical; Signs and Symptoms

Study Officials

• Tasen Wei, Doctor

  Changhua Christian Hospital

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director, Physical Medical and Rehabilitation, Principal Investigator, Clinical Professor

Study Record Dates

• First Submitted: December 28, 2018
• First Posted: January 10, 2019
• Study Start: February 1, 2019
• Primary Completion: September 30, 2022
• Study Completion: September 30, 2022
• Last Updated: November 1, 2022

Record last verified: 2022-10

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)