Physical DisabilityNCT01374334
Lower Extremities Muscle Strength and Power Thresholds Required for Mobility Independence
An observational study of Physical Disability, run by State University of New York - Upstate Medical University.
Trial summary
Aging is associated with loss of muscle strength and a serious import of physical disability. Treatment of age-related physical disability should focus on the prevention of the condition rather than the consequences. Need to modify daily tasks is an early sign of future mobility disability. Read more about this study
- Who is it for?
- Ages 65 years and olderHealthy volunteers can take part
- Conditions the study is for
- Physical Disability
- How many people
- 53 participants
- Where
- No sites listed yet
- Study dates
- Dec 2008to Oct 2011
- Phase
- Observational
- 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 65 years and older
- All sexes
- Healthy volunteers accepted
- Older adult
Study population: fifty-three community dwelling male (21) and female (32) older adults (76.4±5.2 years) were observed performing a chair rise, negotiating stairs, kneeling from a standing position, and rising from supine to stand.
Who may be able to join
- 65 years and older
- no major health problems
Who cannot join
- Participants were not invited for further testing if they were unable to understand basic English, or reported health problems that contraindicated strength and functional testing.
- Examples of such exclusion criteria included severe orthopedic limitations, uncontrolled cardiovascular or metabolic diseases, recent/unhealed fractures, disorders with highly variable course (e.g. multiple sclerosis), severe cognitive impairments, or a score of 20/30 or below on the Mini-Mental State Examination (MMSE) test (Folstein,M.F. 1975; Jensen,J. 2003;Tombaugh,T.N. 1992;).
About this study
Official title: Lower Extremities Muscle Strength and Power Thresholds Required for Mobility Independence in Older Adults
Aging is associated with loss of muscle strength and a serious import of physical disability. Treatment of age-related physical disability should focus on the prevention of the condition rather than the consequences. Need to modify daily tasks is an early sign of future mobility disability. Many older adults who utilize daily task modifications report no mobility difficulty. Neglect to self-report task modification may delay intervention. Identifying objective marker of task modification will help to identify task modifiers.
Read the detailed description
Background: There is a significant rise in the number of people who are living well into old age. Aging is associated with loss of muscle strength and a serious import of physical disability. Age-related physical disability is associated with physical dependence, poor quality of life, and mortality. Treatment of age-related physical disability should focus on the prevention of the condition rather than the consequences. Need to modify daily tasks is an early sign of future mobility disability. Many older adults who utilize daily task modifications report no mobility difficulty. Neglect to self-report task modification may delay intervention. Identifying objective marker of task modification will help to identify task modifiers. Loss of muscle strength is associated with mobility decline. Older adults who engage in habitual physical activity (PA) are more likely to maintain physical independence until shortly before the natural end of their lives. Yet, many older adults are not physically active. Health-care professional in general and physical therapists in particular, are in a unique position to promote PA among older adults. Healthcare providers who habitually engage in PA are more likely to consult their patients on PA guidelines.
Purposes: The purposes of the following studies were to: 1) examine lower extremity muscle strength across subjects who do, and do not utilize task modifications, 2) to determine the strength of the association between lower extremity muscle strength and daily task modifications in older adults living independently, 3) identify functionally relevant isometric and isokinetic cutpoints of lower extremity muscle strength below which daily task modifications are more prevalent, 4) to compare the relative diagnostic accuracy of isometric versus isokinetic strength cutpoints as they relate to daily task modifications, 5) estimate the rate of participation in moderate and vigorous physical activity (PA) among student physical therapists (SPTs), 6) compare these estimates to rates of PA among US adults, and 7) assess barriers to PA among SPTs
Methods: To address the first two purposes, fifty-three community dwelling male (21) and female (32) older adults (76.4±5.2 years) were observed performing a chair rise, negotiating stairs, kneeling from a standing position, and rising from supine to stand. Levels of daily task modifications were assessed using a previously described, valid, and reliable tool [MOD]. The MOD assesses task modifications using six hierarchically ranked categories from zero (no modification) to five (refusal). Rankings were summed across tasks. A score of ≥5 points on the summed MOD score was the cutpoint between a classification of daily Task-Modifiers (TM) and None-Task-Modifiers (NTM). Normalized to body weight Isometric measures of peak muscle torque were obtained from the hip extensors, knee extensors, and ankle plantar flexors using a Biodex testing device. A net anti-gravity composite measure of isometric lower extremity muscle force production in the sagittal plane (NETforce) was calculated by summing the normalized torques from the three muscle groups. An independent t-test was used to compare groups (TM vs. NTM) across the dependent measures of muscular torque. A logistic regression model was used to determine the association between torque measures and group assignment.
To address the third and the forth purposes same fifty-three community dwelling male (21) and female (32) older adults (76.4±5.2 years) were observed performing same activities as above. Normalized to body weight isometric and isokinetic (60⁰ per second) measures of peak muscle strength were obtained from the hip extensors, knee extensors, and ankle plantar flexors using a Biodex Isokinetic testing device. A composite torque outputs were calculated by summing the normalized torques from the three muscle groups. An independent t-test was used to compare groups (TM vs. NTM) across the dependent measures of muscular torque. Discriminant analysis{{1397 Hasegawa,R. 2008}} was repeated for each predictor variable separately to determine the minimal strength cutpoints of normalized composite lower extremity isometric and isokinetic strength outputs that would optimally differentiate between the TM and NTM groups. An ROC curve analysis was performed to determine the sensitivity and specificity. A repeated, separated logistic regression with the group classification as the dependent variable and the lower extremity strength measures as the independent variables was conducted. For all statistical tests, a P-value of less than 0.05 was considered statistically significant. All data analyses were performed using SPSS (version 18; SPSS Inc., Chicago, IL, USA). A p value of .05 was used the reject the null hypothesis.
To address the last three purposes, we applied a cross-sectional survey design [N = 126 SPTs enrolled in a professional (entry level) physical therapist education program]. Frequencies, percentages, and cross-tabulations followed by chi-square tests were used to address purposes number 5 and 6. Qualitative (coding) followed by non-parametric statistical procedures were used to assess purpose number 7.
- Conditions
- Physical Disability
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jun 2011 (estimated)
- Study startDec 2008
- Primary completionSep 2011
- Study completionOct 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Physical DisabilityStudies 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
- Observational
- Observational model
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 53 participants (actual)
Sponsor and investigators
- Lead sponsor
- State University of New York - Upstate Medical University
- Sponsor type
- University, hospital or other
- Investigators
- Moshe Marko, Principal investigator, State University of New York - Upstate Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01374334
- Sponsor's protocol ID
- ThresholdMarko
- Status last verified
- Aug 2010
- First submitted
- 14 Jun 2011
- Last updated
- 20 Oct 2021
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Lower Extremities Muscle Strength and Power Thresholds Required for Mobility Independence in Older Adults
- ClinicalTrials.gov ID
- NCT01374334
- Acronym / sponsor ID
- ThresholdMarko
- Conditions
- Physical Disability
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 53 participants (actual)
- Lead sponsor
- State University of New York - Upstate Medical UniversityUniversity, hospital or other
- Study start
- Dec 2008 (actual)
- Primary completion
- Sep 2011 (actual)
- Study completion
- Oct 2011 (actual)
- First posted
- 15 Jun 2011 (estimated)
- 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.
Aging is associated with loss of muscle strength and a serious import of physical disability. Treatment of age-related physical disability should focus on the prevention of the condition rather than the consequences. Need to modify daily tasks is an early sign of future mobility disability. Many older adults who utilize daily task modifications report no mobility difficulty. Neglect to self-report task modification may delay intervention. Identifying objective marker of task modification will help to identify task modifiers.
Detailed description
Background: There is a significant rise in the number of people who are living well into old age. Aging is associated with loss of muscle strength and a serious import of physical disability. Age-related physical disability is associated with physical dependence, poor quality of life, and mortality. Treatment of age-related physical disability should focus on the prevention of the condition rather than the consequences. Need to modify daily tasks is an early sign of future mobility disability. Many older adults who utilize daily task modifications report no mobility difficulty. Neglect to self-report task modification may delay intervention. Identifying objective marker of task modification will help to identify task modifiers. Loss of muscle strength is associated with mobility decline. Older adults who engage in habitual physical activity (PA) are more likely to maintain physical independence until shortly before the natural end of their lives. Yet, many older adults are not physically active. Health-care professional in general and physical therapists in particular, are in a unique position to promote PA among older adults. Healthcare providers who habitually engage in PA are more likely to consult their patients on PA guidelines.
Purposes: The purposes of the following studies were to: 1) examine lower extremity muscle strength across subjects who do, and do not utilize task modifications, 2) to determine the strength of the association between lower extremity muscle strength and daily task modifications in older adults living independently, 3) identify functionally relevant isometric and isokinetic cutpoints of lower extremity muscle strength below which daily task modifications are more prevalent, 4) to compare the relative diagnostic accuracy of isometric versus isokinetic strength cutpoints as they relate to daily task modifications, 5) estimate the rate of participation in moderate and vigorous physical activity (PA) among student physical therapists (SPTs), 6) compare these estimates to rates of PA among US adults, and 7) assess barriers to PA among SPTs
Methods: To address the first two purposes, fifty-three community dwelling male (21) and female (32) older adults (76.4±5.2 years) were observed performing a chair rise, negotiating stairs, kneeling from a standing position, and rising from supine to stand. Levels of daily task modifications were assessed using a previously described, valid, and reliable tool [MOD]. The MOD assesses task modifications using six hierarchically ranked categories from zero (no modification) to five (refusal). Rankings were summed across tasks. A score of ≥5 points on the summed MOD score was the cutpoint between a classification of daily Task-Modifiers (TM) and None-Task-Modifiers (NTM). Normalized to body weight Isometric measures of peak muscle torque were obtained from the hip extensors, knee extensors, and ankle plantar flexors using a Biodex testing device. A net anti-gravity composite measure of isometric lower extremity muscle force production in the sagittal plane (NETforce) was calculated by summing the normalized torques from the three muscle groups. An independent t-test was used to compare groups (TM vs. NTM) across the dependent measures of muscular torque. A logistic regression model was used to determine the association between torque measures and group assignment.
To address the third and the forth purposes same fifty-three community dwelling male (21) and female (32) older adults (76.4±5.2 years) were observed performing same activities as above. Normalized to body weight isometric and isokinetic (60⁰ per second) measures of peak muscle strength were obtained from the hip extensors, knee extensors, and ankle plantar flexors using a Biodex Isokinetic testing device. A composite torque outputs were calculated by summing the normalized torques from the three muscle groups. An independent t-test was used to compare groups (TM vs. NTM) across the dependent measures of muscular torque. Discriminant analysis{{1397 Hasegawa,R. 2008}} was repeated for each predictor variable separately to determine the minimal strength cutpoints of normalized composite lower extremity isometric and isokinetic strength outputs that would optimally differentiate between the TM and NTM groups. An ROC curve analysis was performed to determine the sensitivity and specificity. A repeated, separated logistic regression with the group classification as the dependent variable and the lower extremity strength measures as the independent variables was conducted. For all statistical tests, a P-value of less than 0.05 was considered statistically significant. All data analyses were performed using SPSS (version 18; SPSS Inc., Chicago, IL, USA). A p value of .05 was used the reject the null hypothesis.
To address the last three purposes, we applied a cross-sectional survey design [N = 126 SPTs enrolled in a professional (entry level) physical therapist education program]. Frequencies, percentages, and cross-tabulations followed by chi-square tests were used to address purposes number 5 and 6. Qualitative (coding) followed by non-parametric statistical procedures were used to assess purpose number 7.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
- Study population
- fifty-three community dwelling male (21) and female (32) older adults (76.4±5.2 years) were observed performing a chair rise, negotiating stairs, kneeling from a standing position, and rising from supine to stand.
Key inclusion criteria (2 listed)
- 65 years and older
- no major health problems
Key exclusion criteria (2 listed)
- Participants were not invited for further testing if they were unable to understand basic English, or reported health problems that contraindicated strength and functional testing.
- Examples of such exclusion criteria included severe orthopedic limitations, uncontrolled cardiovascular or metabolic diseases, recent/unhealed fractures, disorders with highly variable course (e.g. multiple sclerosis), severe cognitive impairments, or a score of 20/30 or below on the Mini-Mental State Examination (MMSE) test (Folstein,M.F. 1975; Jensen,J. 2003;Tombaugh,T.N. 1992;).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
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 20 Oct 2021.
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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.
Moshe Marko principal investigator
State University of New York - Upstate Medical University
Questions about this trial
What is this clinical trial studying?
An observational study of Physical Disability, run by State University of New York - Upstate Medical University.
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 2 inclusion and 2 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 20 Oct 2021. Status can change between updates, so confirm with the study contact before making plans.
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.
Where can I read the original study information?
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 20 Oct 2021.