Condition or disease | Intervention/treatment | Phase |
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Spinal Cord Injuries | Other: Resistance training | Not Applicable |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 11 participants |
Allocation: | N/A |
Intervention Model: | Single Group Assignment |
Intervention Model Description: | pre-post |
Masking: | None (Open Label) |
Primary Purpose: | Prevention |
Official Title: | Resistance Training to Improve Strength and Functional Trunk Stability in Adults With Paraplegia |
Actual Study Start Date : | November 24, 2015 |
Actual Primary Completion Date : | March 19, 2019 |
Actual Study Completion Date : | March 19, 2019 |
Arm | Intervention/treatment |
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Resistance Training
. Participants will engage in strengthening exercises using a cable tower while seated. These movements will include trunk flexion and extension, diagonal trunk rotation, and lateral trunk flexion. The goal for resistance training frequency (Weeks 1-8) will be three times per week, lasting about 30-45 minutes per session including warm-up/cool-down. Performance during exercise sessions will be monitored by study staff who will progress the participant to exercises of greater intensity (increasing number of repetitions, sets, or resistance load; on an individual basis over the 8-week intervention period according to the participant's level of readiness). This progression will also be guided by a strength training protocol. Resistance intensity of each exercise will also be determined based on the initial maximal strength performing that exercise
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Other: Resistance training
Participants will engage in strengthening exercises using a cable tower while seated. These movements will include trunk flexion and extension, diagonal trunk rotation, and lateral trunk flexion. The goal for resistance training frequency (Weeks 1-8) will be three times per week, lasting about 30-45 minutes per session including warm-up/cool-down, for a duration of eight weeks. Resistance intensity of each exercise will also be determined based on the initial maximal strength performing that exercise: Weeks 1-4 will be 50-60% of the baseline calculated 1 repetition maximum (RM) values; Weeks 5-8 will use resistive loads equivalent to 50-60% of Week 4 1RM calculations
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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria: To be included in the study, all subjects must be adults (>18 years of age) and:
Exclusion Criteria: Participants must not be enrolled in any strengthening protocol or rehabilitation therapy for strengthening during the time of the study. Participants must not have serious comorbidities that could interfere with the ability to participate in an exercise program (musculoskeletal, cardiovascular, and neurological [other than SCI]). Specifically, participants will be excluded if they have: 1) Musculoskeletal injuries that have not healed completely, 2) Had heart surgery or are status post-myocardial infarction (MI) in the last 4 to 6 months, 3) Unstable angina, 4) Uncontrolled hypertension (systolic blood pressure ≥160 mm Hg and/or diastolic blood pressure ≥100 mm Hg), 5) uncontrolled dysrhythmias, 6) Recent history of congestive heart failure that has not been evaluated and effectively treated, 7) Severe stenotic or regurgitant valvular disease, or 8) Hypertrophic cardiomyopathy.
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No Contacts or Locations Provided
Tracking Information | |||||
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First Submitted Date ICMJE | May 10, 2019 | ||||
First Posted Date ICMJE | May 14, 2019 | ||||
Last Update Posted Date | May 14, 2019 | ||||
Actual Study Start Date ICMJE | November 24, 2015 | ||||
Actual Primary Completion Date | March 19, 2019 (Final data collection date for primary outcome measure) | ||||
Current Primary Outcome Measures ICMJE |
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Original Primary Outcome Measures ICMJE | Same as current | ||||
Change History | No Changes Posted | ||||
Current Secondary Outcome Measures ICMJE |
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Original Secondary Outcome Measures ICMJE | Same as current | ||||
Current Other Pre-specified Outcome Measures | Not Provided | ||||
Original Other Pre-specified Outcome Measures | Not Provided | ||||
Descriptive Information | |||||
Brief Title ICMJE | Resistance Training to Improve Strength and Functional Trunk Stability in Adults With Paraplegia | ||||
Official Title ICMJE | Resistance Training to Improve Strength and Functional Trunk Stability in Adults With Paraplegia | ||||
Brief Summary | The purpose of this study is to examine the effectiveness of an 8- week resistance training routine to improve functional trunk strength, muscle activation, and physical functioning in exercise in 30 adults with paraplegic SCI. This study will also examine outcomes of confidence in one's ability to avoid falling during balance challenges, and self-efficacy for participating in exercise activity. | ||||
Detailed Description |
I. BACKGROUND AND SIGNIFICANCE Trunk stability and mobility are essential to engage in everyday life. In general, adults in the United State have weak "core" or trunk strength, resulting from weak abdominal and back musculature as well as weak muscles that assist in moving the trunk. After a spinal cord injury (SCI), the trunk becomes even less stable as there are fewer innervated muscles available to support trunk control and movement. In the absence of strong or innervated trunk-stabilizing muscles, adults with paraplegia may use compensatory patterns of maintaining an upright posture during balance challenges, which could lead to pain and musculoskeletal injury. For these adults with paraplegia, dynamic seated postural control is greatly needed during wheelchair mobility, transfers, and safe performance of activities of daily living. This trunk control enables the individual to bend down, lean from side to side, and recover from these positions without fear of falling. Additionally, increasing trunk strength and posture and control may result in enhanced functional independence, with greater range of motion and ability to efficiently mobilize the upper extremities. Evidence clearly indicates that strength and function declines in adults with chronic SCI can be mitigated by regular exercise, and the ability to stabilize the trunk has been thought to increase during upper body resistance training among adults with chronic paraplegia. Effective interventions that enhance trunk control and strength in this population are lacking, with preliminary studies including trunk strengthening as a preparatory activity for assisted ambulation. Furthermore, trunk strengthening is not addressed as a preventive intervention in rehabilitation for adults with paraplegia, though it is important to train whichever trunk muscles are available to support functional independence and safety. The purpose of this study is to examine the effectiveness of an 8- week resistance training routine to improve functional trunk strength, muscle activation, and physical functioning in exercise in 30 adults with paraplegic SCI. This study will also examine outcomes of confidence in one's ability to avoid falling during balance challenges, and self-efficacy for participating in exercise activity. Participants will serve as their own control in this pre-post design. II. SPECIFIC AIMS
Hypothesis: Upon completing the resistance program, participants will report declines in fear of falling, and gains in self-efficacy to participate in exercise activity. V. STUDY PROCEDURES Methods of data collection: The proposed project is a randomized controlled study in which participants will complete a baseline assessment session. During the baseline session (Week 0 of the resistance training program), demographic and clinical data will be collected, including detailed health history. Further assessments will take place at 4-week and 8-week time points of the resistance training program. The assessments will take place in-person at Spaulding Hospital Cambridge (ExPD). Please see Study Assessments section for schedule of testing participants in either condition. Based on their reported medical history participants may also be asked to provide additional medical records or may need further testing or physician clearance to determine their eligibility and the safety of their participation in this program which includes regular vigorous exercise (i.e. cardiology clearance, orthopedic evaluation, ASIA exam).These additional tests or medical visits may or may not be covered by insurance. The participant will be responsible for obtaining any additional testing or clearance and providing the program with medical records or results. The duration of the entire study including recruitment, data analyses, and manuscript preparation is anticipated to be approximately 2-3 years. Training Protocols 1) Resistance Training Group Participants will be provided up to a week (Week 0) of training to attain proficiency in using the resistance equipment, and to determine need for external assistance for safety or to adjust resistance levels and cables. Participants will engage in strengthening exercises using a cable tower while seated. These movements will include trunk flexion and extension, diagonal trunk rotation, and lateral trunk flexion. The goal for resistance training frequency (Weeks 1-8) will be three times per week, lasting about 30-45 minutes per session including warm-up/cool-down, for a duration of eight weeks. Performance during exercise sessions will be monitored by study staff that will progress the participant to exercises of greater intensity (increasing number of repetitions, sets, or resistance load; on an individual basis over the 8-week intervention period according to the participant's level of readiness). This progression will also be guided by a strength training protocol, as each participant indicates s/he are doing well with the exercises, are not experiencing pain, and specify a decrease in the challenge level of particular exercises. Resistance intensity of each exercise will also be determined based on the initial maximal strength performing that exercise: Weeks 1-4 will be 50-60% of the baseline calculated 1 repetition maximum (RM) values; Weeks 5-8 will use resistive loads equivalent to 50-60% of Week 4 1RM calculations; the final session during Week 8 will be used to determine final strength values (see Measurement and Testing Protocols below for further details). There is no limit or specific requirement for training sessions that must be attended to continue participating in this protocol. Subjects will be encouraged by study staff to attend three training sessions per week. Un-reported missed training session will be followed up with a phone call to document why the training session was missed and to encourage prompt return to training sessions as soon as possible. |
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Study Type ICMJE | Interventional | ||||
Study Phase ICMJE | Not Applicable | ||||
Study Design ICMJE | Allocation: N/A Intervention Model: Single Group Assignment Intervention Model Description: pre-post Masking: None (Open Label)Primary Purpose: Prevention |
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Condition ICMJE | Spinal Cord Injuries | ||||
Intervention ICMJE | Other: Resistance training
Participants will engage in strengthening exercises using a cable tower while seated. These movements will include trunk flexion and extension, diagonal trunk rotation, and lateral trunk flexion. The goal for resistance training frequency (Weeks 1-8) will be three times per week, lasting about 30-45 minutes per session including warm-up/cool-down, for a duration of eight weeks. Resistance intensity of each exercise will also be determined based on the initial maximal strength performing that exercise: Weeks 1-4 will be 50-60% of the baseline calculated 1 repetition maximum (RM) values; Weeks 5-8 will use resistive loads equivalent to 50-60% of Week 4 1RM calculations
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Study Arms ICMJE | Resistance Training
. Participants will engage in strengthening exercises using a cable tower while seated. These movements will include trunk flexion and extension, diagonal trunk rotation, and lateral trunk flexion. The goal for resistance training frequency (Weeks 1-8) will be three times per week, lasting about 30-45 minutes per session including warm-up/cool-down. Performance during exercise sessions will be monitored by study staff who will progress the participant to exercises of greater intensity (increasing number of repetitions, sets, or resistance load; on an individual basis over the 8-week intervention period according to the participant's level of readiness). This progression will also be guided by a strength training protocol. Resistance intensity of each exercise will also be determined based on the initial maximal strength performing that exercise
Intervention: Other: Resistance training
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Publications * | Not Provided | ||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||
Recruitment Status ICMJE | Completed | ||||
Actual Enrollment ICMJE |
11 | ||||
Original Actual Enrollment ICMJE | Same as current | ||||
Actual Study Completion Date ICMJE | March 19, 2019 | ||||
Actual Primary Completion Date | March 19, 2019 (Final data collection date for primary outcome measure) | ||||
Eligibility Criteria ICMJE |
Inclusion Criteria: To be included in the study, all subjects must be adults (>18 years of age) and:
Exclusion Criteria: Participants must not be enrolled in any strengthening protocol or rehabilitation therapy for strengthening during the time of the study. Participants must not have serious comorbidities that could interfere with the ability to participate in an exercise program (musculoskeletal, cardiovascular, and neurological [other than SCI]). Specifically, participants will be excluded if they have: 1) Musculoskeletal injuries that have not healed completely, 2) Had heart surgery or are status post-myocardial infarction (MI) in the last 4 to 6 months, 3) Unstable angina, 4) Uncontrolled hypertension (systolic blood pressure ≥160 mm Hg and/or diastolic blood pressure ≥100 mm Hg), 5) uncontrolled dysrhythmias, 6) Recent history of congestive heart failure that has not been evaluated and effectively treated, 7) Severe stenotic or regurgitant valvular disease, or 8) Hypertrophic cardiomyopathy. - |
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Sex/Gender ICMJE |
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Ages ICMJE | 18 Years and older (Adult, Older Adult) | ||||
Accepts Healthy Volunteers ICMJE | No | ||||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
Listed Location Countries ICMJE | Not Provided | ||||
Removed Location Countries | |||||
Administrative Information | |||||
NCT Number ICMJE | NCT03949699 | ||||
Other Study ID Numbers ICMJE | 2015P001481 | ||||
Has Data Monitoring Committee | No | ||||
U.S. FDA-regulated Product |
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IPD Sharing Statement ICMJE | Not Provided | ||||
Responsible Party | Hannah W Mercier, Spaulding Rehabilitation Hospital | ||||
Study Sponsor ICMJE | Spaulding Rehabilitation Hospital | ||||
Collaborators ICMJE | Not Provided | ||||
Investigators ICMJE | Not Provided | ||||
PRS Account | Spaulding Rehabilitation Hospital | ||||
Verification Date | May 2019 | ||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |