StrokeNCT03798418
Sarcopenia and Risk of Falls in Patients With Major Chronic Diseases
A study testing elastic band strengthening exercise and diet counseling in people with Stroke and Osteoporosis, run by Changhua Christian Hospital at 1 site in Taiwan.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Stroke, Osteoporosis, Chronic Kidney Diseases
- What is being tested?
- elastic band strengthening exercise and diet counseling
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 186 participants
- Where
- 1 siteTaiwan
- Study dates
- 1 Feb 2019to 30 Sep 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 55-85 years old
- 3-6 months after onset
- walk independently for at least 10m
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Stroke, Osteoporosis, Chronic Kidney Diseases, Cancer
- Being tested
- elastic band strengthening exercise, diet counseling
- Keywords
- Sarcopenia, stroke, osteoporosis, chronic kidney disease, cancer, balance and gait, fall
- Medical subject headings
- Stroke, Osteoporosis, Renal Insufficiency, Chronic, Neoplasms, Sarcopenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
elastic band strengthening exerciseBehavioural
Also called thera-band strengthening exercise
2-3days per week(150min per week)
diet counselingDietary supplement
Also called nutrition counseling
each patients in this group will receive4-5times diet counseling
| Study group | Role | What they receive |
|---|---|---|
| exercise group | Active comparator | elastic band strengthening exercise Receives: Behavioral: elastic band strengthening exercise |
| exercise combine diet counseling group | Experimental | elastic band strengthening exercise combined diet counseling. Receives: Behavioral: elastic band strengthening exercise; Dietary Supplement: diet counseling |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change of walking speed
distance: 6m, patients can walk with foor orthosis and assistive devices
Measured: 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
Measured: before intervention; follow-up: 3 months after intervention
Change of postural sway displacement
Use computerized dynography to measure the postural sway displacement (mm)
Measured: before intervention; follow-up: 3 months after intervention
Change of postural sway velocity
Use computerized dynography to measure the postural sway velocity (mm/s)
Measured: before intervention; follow-up: 3 months after intervention
Change of postural sway area
Use computerized dynography to measure the postural sway area (mm^2)
Measured: before intervention; follow-up: 3 months after intervention
Change of step time
Use computerized dynography to measure spatial gait parameter: step time (ms)
Measured: before intervention; follow-up: 3 months after intervention
Change of stance time
Use computerized dynography to measure spatial gait parameter: stance time (ms)
Measured: before intervention; follow-up: 3 months after intervention
Change of swing time
Use computerized dynography to measure spatial gait parameter: swing time (ms)
Measured: 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)
Measured: 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)
Measured: before intervention; follow-up: 3 months after intervention
Change of step length
Use computerized dynography to measure spatial gait parameter: step distance (mm)
Measured: before intervention; follow-up: 3 months after intervention
Change of stance length
Use computerized dynography to measure spatial gait parameter: stance distance (mm)
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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)
Measured: 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.
Measured: 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.
Measured: before intervention; follow-up: 3 months after intervention
Secondary outcomes (14)
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.
Measured: 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.
Measured: 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.
Measured: before intervention; follow-up: 3 months after intervention
Change of concentration of Hemoglobin (Hb)
The concentration of Hb in the blood test.
Measured: 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
Measured: Time Frame: before intervention; follow-up: 3 months after intervention
Change of concentration of Cholesterol
The concentration of Cholesterol in the blood test.
Measured: before intervention; follow-up: 3 months after intervention
Change of concentration of Triglyceride
The concentration of Triglyceride in the blood test.
Measured: before intervention; follow-up: 3 months after intervention
Change of concentration of Transferrin
The concentration of Transferrin in the blood test.
Measured: 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
Measured: 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)
Measured: before intervention; follow-up: 3 months after intervention
Change of Body Mass Index (BMI)
(body weight) kg/(height) m*(height)m
Measured: 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.
Measured: 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
Measured: 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.
Measured: before intervention; follow-up: 3 months after intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jan 2019
- Study start1 Feb 2019
- Primary completion30 Sep 2022
- Study completion30 Sep 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for StrokeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 186 participants (actual)
Sponsor and investigators
- Lead sponsor
- Changhua Christian Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ta-Sen Wei,MD, Changhua Christian Hospital
- Investigators
- Tasen Wei, Doctor, Study director, Changhua Christian Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03798418
- Sponsor's protocol ID
- CCH-170208
- Status last verified
- Oct 2022
- First submitted
- 28 Dec 2018
- Last updated
- 1 Nov 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: only for research
Publications
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.
PubMed 24785098Stapleton 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.
PubMed 11518445Hyndman 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.
PubMed 11833018Kutner 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.
PubMed 25852886Cook 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.
PubMed 17699348Couch 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.
PubMed 24415363Liu 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.
PubMed 19588334
Study at a glance
From the registry record, last updated by the sponsor on 1 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sarcopenia and Risk of Falls in Patients With Major Chronic Diseases - Effects of Therapeutic Exercise and Nutrition Intervention
- ClinicalTrials.gov ID
- NCT03798418
- Acronym / sponsor ID
- CCH-170208
- Conditions
- Stroke, Osteoporosis, Chronic Kidney Diseases, Cancer
- Keywords
- Sarcopenia, stroke, osteoporosis, chronic kidney disease, cancer, balance and gait, fall
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 186 participants (actual)
- Lead sponsor
- Changhua Christian HospitalUniversity, hospital or other
- Study start
- 1 Feb 2019 (actual)
- Primary completion
- 30 Sep 2022 (actual)
- Study completion
- 30 Sep 2022 (actual)
- First posted
- 10 Jan 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| exercise group | Active comparator | Behavioral: elastic band strengthening exerciseelastic band strengthening exercise |
| exercise combine diet counseling group | Experimental | Behavioral: elastic band strengthening exercise, Dietary Supplement: diet counselingelastic band strengthening exercise combined diet counseling. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
Key exclusion criteria (6 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| elastic band strengthening exerciseAlso: thera-band strengthening exercise2-3days per week(150min per week) | Behavioural | exercise combine diet counseling group, exercise group |
| diet counselingAlso: nutrition counselingeach patients in this group will receive4-5times diet counseling | Dietary supplement | exercise combine diet counseling group |
Primary outcome
Change of walking speed
Time frame: baseline: before intervention; follow-up: 3 months after intervention
distance: 6m, patients can walk with foor orthosis and assistive devices
Change of grip force
Time frame: before intervention; follow-up: 3 months after intervention
Use a grip force meter (kg) to test both hands for test 3 times
Change of postural sway displacement
Time frame: before intervention; follow-up: 3 months after intervention
Use computerized dynography to measure the postural sway displacement (mm)
Change of postural sway velocity
Time frame: before intervention; follow-up: 3 months after intervention
Use computerized dynography to measure the postural sway velocity (mm/s)
Change of postural sway area
Time frame: before intervention; follow-up: 3 months after intervention
Use computerized dynography to measure the postural sway area (mm^2)
Change of step time
Time frame: before intervention; follow-up: 3 months after intervention
Use computerized dynography to measure spatial gait parameter: step time (ms)
Change of stance time
Time frame: before intervention; follow-up: 3 months after intervention
Use computerized dynography to measure spatial gait parameter: stance time (ms)
Change of swing time
Time frame: before intervention; follow-up: 3 months after intervention
Use computerized dynography to measure spatial gait parameter: swing time (ms)
Change of single support time
Time frame: before intervention; follow-up: 3 months after intervention
Use computerized dynography to measure spatial gait parameter: single support time (ms)
Change of double support time
Time frame: before intervention; follow-up: 3 months after intervention
Use computerized dynography to measure spatial gait parameter: double support time (ms)
Change of step length
Time frame: before intervention; follow-up: 3 months after intervention
Use computerized dynography to measure spatial gait parameter: step distance (mm)
Change of stance length
Time frame: before intervention; follow-up: 3 months after intervention
Use computerized dynography to measure spatial gait parameter: stance distance (mm)
Change of muscle thickness
Time frame: before intervention; follow-up: 3 months after intervention
Use ultrasound to assess muscles morphological parameter: thickness (mm). Target muscles include quadriceps, hamstring, anterior tibialis, gastrocnemius.
Change of muscle fiber length
Time frame: before intervention; follow-up: 3 months after intervention
Use ultrasound to assess muscles morphological parameter: fiber length (mm). Target muscles include quadriceps, hamstring, anterior tibialis, gastrocnemius.
Change of muscle fiber orientation angle
Time frame: before intervention; follow-up: 3 months after intervention
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
Time frame: before intervention; follow-up: 3 months after intervention
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)
Time frame: before intervention; follow-up: 3 months after intervention
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)
Time frame: before intervention; follow-up: 3 months after intervention
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
Time frame: before intervention; follow-up: 3 months after intervention
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.
14 secondary outcomes
Change of concentration of CRP (C-Reactive Protein)
Time frame: before intervention; follow-up: 3 months after intervention
Change of concentration of ALB (Serum albumin)
Time frame: before intervention; follow-up: 3 months after intervention
Change of concentration of Glomerular Filtration Rate (GFR)
Time frame: before intervention; follow-up: 3 months after intervention
Change of concentration of Hemoglobin (Hb)
Time frame: Time Frame: before intervention; follow-up: 3 months after intervention
Change of concentration of Glucose SPOT
Time frame: Time Frame: before intervention; follow-up: 3 months after intervention
Change of concentration of Cholesterol
Time frame: before intervention; follow-up: 3 months after intervention
Change of concentration of Triglyceride
Time frame: before intervention; follow-up: 3 months after intervention
Change of concentration of Transferrin
Time frame: before intervention; follow-up: 3 months after intervention
Change of Berg balance test (BBS)
Time frame: before intervention; follow-up: 3 months after intervention
Change of Fugl-Meyer Assessment (FMA)
Time frame: before intervention; follow-up: 3 months after intervention
Change of Body Mass Index (BMI)
Time frame: before intervention; follow-up: 3 months after intervention
Change of Mini-mental state examination (MMSE)
Time frame: before intervention; follow-up: 3 months after intervention
Change of Modified Ashworth scale (MAS)
Time frame: before intervention; follow-up: 3 months after intervention
Change of Muscle tone
Time frame: before intervention; follow-up: 3 months after intervention
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Nov 2022.
- Background: PubMed 24785098Biolo 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.
- Background: PubMed 11518445Stapleton 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.
- Background: PubMed 11833018Hyndman 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.
- Background: PubMed 25852886Kutner 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.
- Background: PubMed 17699348Cook 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.
- Background: PubMed 24415363Couch 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.
- Background: PubMed 19588334Liu 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.
- Individual participant dataSharing planned: No. only for research
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Tasen Wei, Doctor study director
Changhua Christian Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing elastic band strengthening exercise and diet counseling in people with Stroke and Osteoporosis, run by Changhua Christian Hospital at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Nov 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change of walking speed (time frame: baseline: before intervention; follow-up: 3 months after intervention). The study lists 19 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03798418, which also lists 7 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Nov 2022.