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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.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted15 Jun 2011 (estimated)
  2. Study startDec 2008
  3. Primary completionSep 2011
  4. Study completionOct 2011

Resources

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)
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

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.

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