The Effect of Exercise Training in the Community-dwelling Adults With Chronic Disorders

December 16, 2013 updated by: Far Eastern Memorial Hospital
Previous studies have demonstrated that resistance training (RT) is beneficial to increase muscle strength, improve functional ability and the ability to rapidly produce force, known as the contractile rate of force development (RFD) in older adults. However, much less research has focused on the effect of RT on the lower extremity muscle strength, contractile RFD and impulse in middle-aged and older people with musculoskeletal conditions, especially for osteoporosis (OP) (or osteopenia) or knee osteoarthritis (KOA). Therefore, the purpose of this study was to investigate the effect of RT on the lower extremity muscle strength, RFD and impulse in middle-aged and older people with musculoskeletal conditions, especially for OP and knee OA (KOA). The investigators hypothesized that such a training program would lead to induce not only specific muscle strength enhancement but also an increment in contractile RFD and impulse.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Osteoporosis (OP) and osteoarthritis (OA) are the two most common musculoskeletal conditions in older adults, causing high healthcare costs and negative effects on quality of life. Previous studies have reported that OP and OA has a strong association with sarcopenia, a term defined as age-related involuntary loss of skeletal muscle mass and strength or function.A decline of muscle mass and strength in older adults may limit a variety of activities of daily living (ADLs) and increase morbidity and mortality. However, many ADLs often involve faster limb movements with contraction times of 50 - 200 ms (i.e. sit-to-stand performance and avoiding falls). Therefore, in addition to muscle mass and strength, the ability to rapidly produce force, known as the contractile rate of force development (RFD), and the area under the force-time curve, defined as contractile impulse, seem to be important to adequately characterize the performance of ADLs in older adults. Typically, resistance training (RT) is often prescribed to increase muscle strength, improve functional ability and eliminate much of age-associated muscle atrophy and weakness in a healthy population. Other studies have also shown that implementation of RT can help improve RFD in healthy young and elderly individuals following RT. However, it still unclear that the effect of RT on contractile RFD and impulse in middle-aged and older people with musculoskeletal conditions. Therefore, the aim of this study was to examine the effects on the lower extremity muscle strength, contractile rate of force development (RFD), impulse in middle-aged and older people with osteoporosis (OP)(or osteopenia) or knee osteoarthritis (KOA) after 12 weeks of resistance training.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
58

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Taiwan
      • New Taipei City, Taiwan, 220
        • Tsung-Ching Lin

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

45 years to 90 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

(1) 45 years old or older; (2) diagnosed by a physician with osteoporosis (or osteopenia) or/and osteoarthritis; (3) able to participate safely in a moderately vigorous program of physical activity; (4) not previously taken part in any type of resistance training but were all physically capable of entering exercise.

Exclusion Criteria:

(1) a acute or terminal illness, myocardial infarction within 6 months (or other symptomatic coronary artery disease); (2) uncontrolled hypertension (> 150/90 mmHg); (3) fracture in the previous 6 months; (3) diseases or medication affecting neuromuscular function; (4) physical limitation in sports and were advised not to exercise by doctors.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
No Intervention: control
Maintain regular physical activity as usual, and received health education material about their disease, importance of nutrition and risks factors.
Experimental: hydraulic resistance circuit training
12 weeks resistance training
Procedure: hydraulic resistance circuit training
12 weeks (3 times per week, 40 min circuit) of hydraulic resistance circuit training that consisted of 7 types of equipments for different part of strength training.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Maximum voluntary contraction (MVC)
Time Frame: three months
Muscle strength was measured as maximum voluntary contraction (MVC) of the quadriceps exerted on an isokinetic dynamometer.
three months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Contractile rate of force development (RFD)
Time Frame: three months
Contractile rate of force development (RFD) was derived as the average slope of the initial phase of the torque-time curve (change in torque/change in time) at 0-30, 50, 100, and 200 ms relative to the onset of contraction.
three months
Impulse
Time Frame: three months
Contractile impulse was determined as the area under the torque -time curve in the same time intervals of 0-30, 0-50, 0-100, and 0-200 ms relative to the onset of contraction.
three months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Far Eastern Memorial Hospital

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Chair: Tsung-Ching Lin, Master, Far Eastern Memorial Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 1, 2012

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
July 1, 2013

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 1, 2013

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
December 5, 2013

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 16, 2013

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
December 20, 2013

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
December 20, 2013

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 16, 2013

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
December 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • FEMH-IRB-101020-E

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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