Diabetes MellitusNCT00270855

Exercise to Reduce Obesity in Spinal Cord Injury

A study testing Arm Crank Ergometry and FES Cycle Ergometer in people with Diabetes Mellitus and Obesity, run by VA Office of Research and Development at 1 site in United States.

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

Who is it for?: Ages 18 to 65 years
Conditions the study is for: Diabetes Mellitus, Obesity, Paraplegia
What is being tested?: Arm Crank Ergometry and FES Cycle Ergometer
Type of treatment: Surgery or procedure
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 29 participants
Where: 1 siteUnited States
Study dates: May 2008to Dec 2011
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

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 18 to 65 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Criteria for participation included men and women within the age range of 18-65 years old with BMI>25 kg/m2 who have had T4-L2 Motor-Complete (ASIA A\&B) SCI for duration of greater than 12 months to ensure a homogenous sample.

Who cannot join

persons who were unresponsive to surface neurostimulation
had participated in an FES or ACE exercise (> 60 minutes/week) program within the past 3 months
and those with known orthopedic limitations
CAD
diabetes mellitus (fasting glucose>126 or HgbA1c>7.0) or known family history
hypothyroidism
and/or renal disease were excluded from the study.
Additionally, individuals with uncontrolled autonomic dysreflexia, recent (within 3 months) deep vein thrombosis, or pressure ulcers > Grade II were excluded.

Trial locations and contacts

1 site in 1 country.

United States1 site

Hunter Holmes McGuire VA Medical Center
Richmond, Virginia, 23249

Other trials in United States

About this study

The purpose of this proposal was to evaluate and compare the health benefits of using upper extremity exercise versus functional electrical stimulation for lower extremity exercise. It was our hypothesis that both Functional Electrical Stimulation Leg Cycle Ergometry (FES LCE) exercise and voluntary Arm Crank Ergometry (ACE) upper extremity exercise would increase whole body energy expenditure, thereby increasing muscle mass, insulin sensitivity, glucose effectiveness and improving lipid profiles in adults with paraplegia.

Read the detailed description

Objective: Spinal cord injuries (SCI) predispose individuals to impaired fitness, obesity, glucose intolerance and insulin resistance, placing them at greater risk for diabetes, coronary artery disease, and upper extremity overuse syndrome as body weight increases. The specific objectives for the current proposal were to compare the impact of FES (functional electrical stimulation) lower extremity exercise versus upper extremity arm crank ergometry on energy metabolism, body composition and fat deposition, insulin sensitivity, glucose effectiveness, lower extremity bone mineral density and lipid profiles, in adults with complete paraplegia. Research Plan: A randomized, baseline-controlled, prospective, 16-week interventional trial was employed to assess the impact of FES LCE versus volitional arm crank ergometry exercise on energy metabolism, body composition and fat deposition, insulin sensitivity, glucose effectiveness, lower extremity bone mineral density and lipid profiles in adults with complete paraplegia. Methods: Twenty-four 18-65 y.o. individuals with motor complete T4-L2 SCI were assigned to either FES lower extremity exercise or upper extremity arm crank ergometry to compare impact on energy expenditure, obesity, and insulin sensitivity. Both groups were provided similar nutritional assessments and intervention. Exercise training consisted of five, 40-minute sessions at 70% maximal heart rate (HRmax) each week for a total of 16 weeks. Resting metabolic rate, exercise energy expenditure, body composition by DXA, insulin sensitivity, glucose effectiveness, lipid profiles, and lower extremity bone mineral density (BMD) were determined before and after 16-week exercise interventions.

Conditions: Diabetes Mellitus, Obesity, Paraplegia, Quadriplegia, Spinal Cord Injury
Being tested: Arm Crank Ergometry, FES Cycle Ergometer
Keywords: Body Composition, Exercise, Glucose Tolerance, Insulin Sensitivity, Functional Electric Stimulation
Medical subject headings: Diabetes Mellitus, Obesity, Paraplegia, Quadriplegia, Spinal Cord Injuries, Motor Activity, Insulin Resistance

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Arm Crank ErgometryProcedure or surgery
Use of an upper body cycle to perform exercise. 10-minute warm up, 40 minutes @ 70%HRMax (50RPM), 10 minute cool down 5x/week x 16 weeks
FES Cycle ErgometerProcedure or surgery
Use of an FES cycle ergometer to perform exercise. 10-minute warm up, 40 minutes @ 70%HRMax (50RPM), 10 minute cool down 5x/week x 16 weeks

Study groups in NCT00270855
Study group	Role	What they receive
Arm Crank Ergometer	Other	Upper body Cycle ergometer Exercise: 10-minute warm up, 40 minutes @ 70%HRMax (50RPM), 10 minute cool down 5x/week x 16 weeks Receives: Procedure: Arm Crank Ergometry
FESLCE	Other	Functional Electrical Stimulation Leg Cycle Ergometer Exercise: 10-minute warm up, 40 minutes @ 70%HRMax (50RPM), 10 minute cool down 5x/week x 16 weeks Receives: Procedure: FES Cycle Ergometer

What is being measured

The primary outcome is the main question the study is designed to answer.

Change in % Body Fat
Change in % Body Fat after 16 week intervention. Change score was calculated as final value (i.e., post intervention variable) minus baseline value.
Measured: baseline, 16 weeks
Change in Fat Mass
Change in Fat Mass (Kg) after 16 week intervention. Change score was calculated as final value (i.e., post intervention variable) minus baseline value.
Measured: Baseline, 16 Weeks
Change in Fat-Free Mass
Fat-Free Mass (kg). Change score was calculated as final value (i.e., post intervention variable) minus baseline value.
Measured: baseline, 16 weeks
Change in Glucose Effectiveness (Sg)
Change in Glucose Effectiveness (min^-1). Change score was calculated as final value (i.e., post intervention variable) minus baseline value.
Measured: Baseline, 16-weeks
Change in Insulin Sensitivity (Si)
Change in insulin sensitivity (min^-1). Change score was calculated as final value (i.e., post intervention variable) minus baseline value.
Measured: Baseline, 16-weeks
%Body Fat Between Groups
Comparison of %body fat between the ACE and FESLCE groups following the 16 week intervention.
Measured: 16 weeks
Fat Mass Between Groups
Comparison of fat mass between the ACE and FESLCE groups following the 16 week intervention.
Measured: 16 weeks
Fat Free Mass Between Groups
Comparison of fat free mass between the ACE and FESLCE groups following the 16 week intervention.
Measured: 16 weeks
Insulin Sensitivity (Si) Between Groups
Comparison of Si between the ACE and FESLCE groups following the 16 week intervention.
Measured: 16 weeks
Glucose Effectiveness (Sg) Between Groups
Comparison of Sg between the ACE and FESLCE groups following the 16 week intervention.
Measured: 16 weeks

Secondary outcomes (14)

Change in Lower Limb Bone Mineral Density
Change in lower limb bone mineral density after 16 week intervention. Change score was calculated as final value (i.e., post intervention variable) minus baseline value.
Measured: baseline, 16 weeks
Change in Lower Limb Bone Mineral Content
Change in lower limb bone mineral content after 16 week intervention. Change score was calculated as final value (i.e., post intervention variable) minus baseline value.
Measured: baseline, 16 weeks
Change in Triglycerides
Change in triglycerides after 16 week intervention. Change score was calculated as final value (i.e., post intervention variable) minus baseline value.
Measured: baseline, 16 weeks
Change in High Density Lipoprotein Cholesterol (HDL)
Change in HDL after 16 week intervention. Change score was calculated as final value (i.e., post intervention variable) minus baseline value.
Measured: baseline, 16 weeks
Change in Low Density Lipoprotein Cholesterol (LDL)
Change in LDL after 16 week intervention. Change score was calculated as final value (i.e., post intervention variable) minus baseline value.
Measured: baseline, 16 weeks
Change in Total Cholesterol (TC)
Change in TC after 16 week intervention. Change score was calculated as final value (i.e., post intervention variable) minus baseline value.
Measured: baseline, 16 weeks
Change in the Ratio of Total Cholesterol to High Density Lipoprotein Cholesterol (TC:HDL)
Change in TC:HDL after 16 week intervention. Change score was calculated as final value (i.e., post intervention variable) minus baseline value.
Measured: Baseline, 16 weeks
Lower Limb Bone Mineral Density Between Groups
Comparison of Lower limb bone mineral density between the ACE and FESLCE groups following the 16 week intervention
Measured: 16 weeks
Lower Limb Bone Mineral Content Between Groups
Comparison of Lower limb bone mineral content between the ACE and FESLCE groups following the 16 week intervention
Measured: 16 weeks
Triglycerides Between Groups
Comparison of Triglycerides between the ACE and FESLCE groups following the 16 week intervention
Measured: 16 weeks
High Density Lipoprotein Cholesterol (HDL) Between Groups
Comparison of HDL between the ACE and FESLCE groups following the 16 week intervention
Measured: 16 weeks
Low Density Lipoprotein Cholesterol (LDL) Between Groups
Comparison of LDL between the ACE and FESLCE groups following the 16 week intervention
Measured: 16 weeks
Total Cholesterol (TC) Between Groups
Comparison of TC between the ACE and FESLCE groups following the 16 week intervention
Measured: 16 weeks
Ratio of Total Cholesterol to High Density Lipoprotein Cholesterol (TC:HDL) Between Groups
Comparison of Ratio of Total Cholesterol to High Density Lipoprotein Cholesterol (TC:HDL) between the ACE and FESLCE groups following the 16 week intervention
Measured: 16 weeks

Timeline

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

May 2008Dec 2011

First posted28 Dec 2005 (estimated)
Study startMay 2008
Primary completionJun 2011
Study completionDec 2011

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Diabetes MellitusStudies of the same condition, open and under way.
More trials run by VA Office of Research and DevelopmentThe sponsor's other registered studies.
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: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 29 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00270855
Sponsor's protocol ID: B3918-R
Other IDs: UL1RR031990
Status last verified: Oct 2017
First submitted: 23 Dec 2005
Last updated: 17 Nov 2017
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 17 Nov 2017. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Exercise to Reduce Obesity in Spinal Cord Injury
ClinicalTrials.gov ID: NCT00270855
Acronym / sponsor ID: B3918-R
Conditions: Diabetes Mellitus, Obesity, Paraplegia, Quadriplegia, Spinal Cord Injury
Keywords: Body Composition, Exercise, Glucose Tolerance, Insulin Sensitivity, Functional Electric Stimulation
Study type: Interventional
Recruitment status: Completed
Enrolment: 29 participants (actual)
Lead sponsor: VA Office of Research and DevelopmentUS federal agency
Collaborators: National Center for Research Resources (NCRR)
Study start: May 2008
Primary completion: Jun 2011 (actual)
Study completion: Dec 2011 (actual)
First posted: 28 Dec 2005 (estimated)
Results: Posted 17 Nov 2017

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Arm Crank Ergometer	Other	Procedure: Arm Crank ErgometryUpper body Cycle ergometer Exercise: 10-minute warm up, 40 minutes @ 70%HRMax (50RPM), 10 minute cool down 5x/week x 16 weeks
FESLCE	Other	Procedure: FES Cycle ErgometerFunctional Electrical Stimulation Leg Cycle Ergometer Exercise: 10-minute warm up, 40 minutes @ 70%HRMax (50RPM), 10 minute cool down 5x/week x 16 weeks

Who may qualify

Ages: 18 to 65 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (1 listed)

Criteria for participation included men and women within the age range of 18-65 years old with BMI>25 kg/m2 who have had T4-L2 Motor-Complete (ASIA A\&B) SCI for duration of greater than 12 months to ensure a homogenous sample.

Key exclusion criteria (8 listed)

persons who were unresponsive to surface neurostimulation
had participated in an FES or ACE exercise (> 60 minutes/week) program within the past 3 months
and those with known orthopedic limitations
CAD
diabetes mellitus (fasting glucose>126 or HgbA1c>7.0) or known family history

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
Arm Crank ErgometryUse of an upper body cycle to perform exercise. 10-minute warm up, 40 minutes @ 70%HRMax (50RPM), 10 minute cool down 5x/week x 16 weeks	Procedure or surgery	Arm Crank Ergometer
FES Cycle ErgometerUse of an FES cycle ergometer to perform exercise. 10-minute warm up, 40 minutes @ 70%HRMax (50RPM), 10 minute cool down 5x/week x 16 weeks	Procedure or surgery	FESLCE

Primary outcome

Change in % Body Fat
Time frame: baseline, 16 weeks
Change in % Body Fat after 16 week intervention. Change score was calculated as final value (i.e., post intervention variable) minus baseline value.
Change in Fat Mass
Time frame: Baseline, 16 Weeks
Change in Fat Mass (Kg) after 16 week intervention. Change score was calculated as final value (i.e., post intervention variable) minus baseline value.
Change in Fat-Free Mass
Time frame: baseline, 16 weeks
Fat-Free Mass (kg). Change score was calculated as final value (i.e., post intervention variable) minus baseline value.
Change in Glucose Effectiveness (Sg)
Time frame: Baseline, 16-weeks
Change in Glucose Effectiveness (min^-1). Change score was calculated as final value (i.e., post intervention variable) minus baseline value.
Change in Insulin Sensitivity (Si)
Time frame: Baseline, 16-weeks
Change in insulin sensitivity (min^-1). Change score was calculated as final value (i.e., post intervention variable) minus baseline value.
%Body Fat Between Groups
Time frame: 16 weeks
Comparison of %body fat between the ACE and FESLCE groups following the 16 week intervention.
Fat Mass Between Groups
Time frame: 16 weeks
Comparison of fat mass between the ACE and FESLCE groups following the 16 week intervention.
Fat Free Mass Between Groups
Time frame: 16 weeks
Comparison of fat free mass between the ACE and FESLCE groups following the 16 week intervention.
Insulin Sensitivity (Si) Between Groups
Time frame: 16 weeks
Comparison of Si between the ACE and FESLCE groups following the 16 week intervention.
Glucose Effectiveness (Sg) Between Groups
Time frame: 16 weeks
Comparison of Sg between the ACE and FESLCE groups following the 16 week intervention.

14 secondary outcomes

Change in Lower Limb Bone Mineral Density
Time frame: baseline, 16 weeks
Change in Lower Limb Bone Mineral Content
Time frame: baseline, 16 weeks
Change in Triglycerides
Time frame: baseline, 16 weeks
Change in High Density Lipoprotein Cholesterol (HDL)
Time frame: baseline, 16 weeks
Change in Low Density Lipoprotein Cholesterol (LDL)
Time frame: baseline, 16 weeks
Change in Total Cholesterol (TC)
Time frame: baseline, 16 weeks
Change in the Ratio of Total Cholesterol to High Density Lipoprotein Cholesterol (TC:HDL)
Time frame: Baseline, 16 weeks
Lower Limb Bone Mineral Density Between Groups
Time frame: 16 weeks
Lower Limb Bone Mineral Content Between Groups
Time frame: 16 weeks
Triglycerides Between Groups
Time frame: 16 weeks
High Density Lipoprotein Cholesterol (HDL) Between Groups
Time frame: 16 weeks
Low Density Lipoprotein Cholesterol (LDL) Between Groups
Time frame: 16 weeks
Total Cholesterol (TC) Between Groups
Time frame: 16 weeks
Ratio of Total Cholesterol to High Density Lipoprotein Cholesterol (TC:HDL) Between Groups
Time frame: 16 weeks

Results and safety

Results posted to the registry on 17 Nov 2017, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Arm Crank Ergometer	15	7
FESLCE	14	6

Primary outcome: Change in % Body Fat

Time frame: baseline, 16 weeks. Mean (Standard Deviation). Unit: Percent Body Fat

Measure	Arm Cycling Ergometer n = 7	FESLCE n = 6
Value	-1.83 (2.72)	-1.68 (0.98)

Arm Cycling Ergometer: p >0.05, t-test, 2 sided
FESLCE: p >0.05, t-test, 2 sided

Population analysed: Two exercise groups consisted of an arm crank ergometry group and an FESLCE group.

Primary outcome: Change in Fat Mass

Time frame: Baseline, 16 Weeks. Mean (Standard Deviation). Unit: Kg

Measure	Arm Cycling Ergometer n = 7	FESLCE n = 6
Value	-1.84 (1.99)	-1.02 (2.55)

Arm Cycling Ergometer: p >0.05, t-test, 2 sided
FESLCE: p >0.05, t-test, 2 sided

Population analysed: Two exercise groups consisted of an arm crank ergometry group and an FESLCE group.

Primary outcome: Change in Fat-Free Mass

Time frame: baseline, 16 weeks. Mean (Standard Deviation). Unit: Kg

Measure	Arm Cycling Ergometer n = 7	FESLCE n = 6
Value	0.90 (3.49)	1.86 (2.42)

Arm Cycling Ergometer: p = 0.519, t-test, 2 sided
FESLCE: p >0.05, t-test, 2 sided

Population analysed: Two exercise groups consisted of an arm crank ergometry group and an FESLCE group.

Primary outcome: Change in Glucose Effectiveness (Sg)

Time frame: Baseline, 16-weeks. Mean (Standard Deviation). Unit: min^-1

Measure	Arm Crank Ergometer n = 7	FESLCE n = 6
Value	0.00 (0.02)	0.01 (0.01)

Arm Crank Ergometer: p = 0.615, t-test, 2 sided
FESLCE: p >0.05, t-test, 2 sided

Population analysed: Two exercise groups consisted of an arm crank ergometry group and an FESLCE group.

14 secondary outcomes are reported in the full results.

Adverse events

Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Arm Cycling Ergometer	0 of 7 (0%)	0 of 7 (0%)	Not reported
FESLCE	0 of 6 (0%)	0 of 6 (0%)	Not reported

Limitations and caveats (from the sponsor): The number of subjects that withdrew lead to small numbers of subjects analyzed.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 17 Nov 2017.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: No

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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.

David R Gater, MD PhD MS principal investigator

Hunter Holmes McGuire VA Medical Center

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Arm Crank Ergometry and FES Cycle Ergometer in people with Diabetes Mellitus and Obesity, run by VA Office of Research and Development at 1 site in United States.

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 1 inclusion and 8 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 17 Nov 2017. 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 United States. 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?

Yes. Results are posted in the registry (first posted 17 Nov 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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 in % Body Fat (time frame: baseline, 16 weeks). The study lists 10 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 NCT00270855.

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 17 Nov 2017.