Sarcopenia and Risk of Falls in Patients With Major Chronic Diseases

NCT ID: NCT03798418

Last Updated: 2022-11-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

186 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-02-01

Study Completion Date

2022-09-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Stroke Osteoporosis Chronic Kidney Diseases Cancer

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

exercise group

elastic band strengthening exercise

Group Type ACTIVE_COMPARATOR

elastic band strengthening exercise

Intervention Type BEHAVIORAL

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

exercise combine diet counseling group

elastic band strengthening exercise combined diet counseling.

Group Type EXPERIMENTAL

elastic band strengthening exercise

Intervention Type BEHAVIORAL

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

diet counseling

Intervention Type DIETARY_SUPPLEMENT

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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

elastic band strengthening exercise

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

Intervention Type BEHAVIORAL

diet counseling

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

Intervention Type DIETARY_SUPPLEMENT

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

thera-band strengthening exercise nutrition counseling

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Changhua Christian Hospital

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Ta-Sen Wei,MD

Director, Physical Medical and Rehabilitation, Principal Investigator, Clinical Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Tasen Wei, Doctor

Role: STUDY_DIRECTOR

Changhua Christian Hospital

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Changhua Christian Hospital

Changhua, , Taiwan

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Taiwan

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type BACKGROUND
PMID: 24785098 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 11518445 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 11833018 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 25852886 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 17699348 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 24415363 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 19588334 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

CCH-170208

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.