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ObesityI'MFITNCT01049698

Improving Muscle for Functional Independence Trial

A study testing Resistance Training and Resistance Training + Diet in people with Obesity, run by Wake Forest University 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

Aging is associated with declines in muscle strength, power, and overall functional ability that lead to disability and loss of independence. Furthermore, the existing high prevalence of obesity in the elderly is greatly exacerbating these aging-related declines in function. Read more about this study

Who is it for?
Ages 65 to 79 yearsHealthy volunteers can take part
Conditions the study is for
Obesity
What is being tested?
Resistance Training and Resistance Training + Diet
Could I receive a placebo?
No, everyone receives an active treatment
How many people
126 participants
Where
1 siteUnited States
Study dates
Feb 2010to May 2014
Phase
Interventional
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 to 79 years
  • All sexes
  • Healthy volunteers accepted
  • Older adult

Who may be able to join

  • BMI=27-34.9 kg/m2
  • No resistance training for past 6 mos
  • Normal cognitive function (MMSE >24)
  • No contraindications for participation in weight loss or resistance exercise including severe arthritis or musculoskeletal disorders, knee or hip replacement or spinal surgery in past year
  • No broken bones in the past 6 months
  • Able to provide own transportation to study visits and intervention
  • Not involved in any other research study and not undergoing physical therapy
  • Not dependent on a cane or walker

Who cannot join

  • Weight loss or gain (±5%) in past 6 months
  • Body mass >136 kg (DXA limit)
  • Current smoker (No nicotine within past year) or evidence of alcohol or drug abuse
  • Insulin dependent or uncontrolled diabetes (FBG >140 mg/dL)
  • Uncontrolled hypertension (BP>180/100 mmHg)
  • Abnormal kidney function or liver blood tests
Show all 12Show fewer
  • Past or current cardiovascular disease, including uncontrolled angina or dysrhythmia, hypertrophic cardiomyopathy, congestive heart failure, PAD, stroke, history of myocardial infarction, use of defibrillator or major heart surgery, or deep vein thrombosis or pulmonary embolus
  • Past or current respiratory disease (requiring steroid treatment or supplemental oxygen)
  • Past or current clinical diagnoses of neurological or hematological disease
  • Use of any medications that could influence study variables (growth/steroid hormones, prescription anti-inflammatory medications, or beta blockers, Coumadin or any other blood thinner, including Plavix, Ticid, and Aggrenox)
  • Cancer requiring treatment in past 2 years, except non-melanoma skin cancers
  • Clinically evident edema or anemia

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Wake Forest University Health Sciences

    Winston-Salem, North Carolina, 27157

Other trials in United States

About this study

Aging is associated with declines in muscle strength, power, and overall functional ability that lead to disability and loss of independence. Furthermore, the existing high prevalence of obesity in the elderly is greatly exacerbating these aging-related declines in function. To date, regular exercise, especially resistance exercise, is the only known treatment to consistently improve muscle function and perhaps delay the onset of disability. However, not all individuals experience the same magnitude of benefit from a given exercise stimulus, and accumulating data show that obesity limits muscle adaptations to chronic exercise.Therefore, the proposed study is designed to determine the effects of caloric restriction on improvements in skeletal muscle function in response to RT.

Read the detailed description

Design Overview:

This is a 5-month randomized trial in 130 older, overweight or obese, sedentary men and women. Phase 1 involves recruitment and screening followed by baseline research testing (Phase 2). Next, subjects will be randomly assigned to one of two 5-month treatments (Phase 3): RT intervention alone (RT) or to an RT with caloric restriction (RT+CR) intervention. Subjects will return for visits the completion of their 5 month intervention. A subset of participants (n=30) will return for an 18 month follow up.

Interventions:

Resistance training+ Caloric Restriction:Participants assigned to RT+CR group will be instructed to follow a hypocaloric diet (-600 kcal/d) for 20 weeks, as well as the resistance training program noted below.In addition, all participants will be provided with a daily calcium (1200 mg/d) and vitamin D (800 IU/d) supplement.The intervention will incorporate meal replacements, nutrition education, and lifestyle behavior modifications.

Resistance training: The maximal weight that can be lifted with correct form in a single repetition (1RM) will be used to prescribe intensity. Strength testing will be repeated every 4 wks and the training loads adjusted so that they are consistent with the 70% 1RM goal. Participants will exercise 3 d/wk on Nautilus resistance machines, under the supervision of two exercise leaders who are trained in basic life support and in emergency management procedures. All exercise will take place at Wake Forest University's Department of Health and Exercise Science Clinical Research Center (CRC). Participants will exercise in small groups which will allow a rotation/rest between machines and enhance the social environment. Heart rate and blood pressure will be measured before and after each session. Subjects will warm-up by walking or cycling for 5 minutes at a slow pace followed by large muscle flexibility exercises. The interventionists will ensure that participants adjust the equipment appropriate to their body size and complete the exercises with correct form. Training sessions will end with a cool-down by walking or cycling for 5 minutes at a slow pace followed by light stretching.

Conditions
Obesity
Being tested
Resistance Training, Resistance Training + Diet
Keywords
Obesity, Overweight, Older adults, resistance training, exercise
Medical subject headings
Obesity, Overweight, Motor Activity

What participants receive

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

  • Resistance TrainingBehavioural

    Also called RT, Nautilus resistance machines

    3 d/wk resistance training

  • Resistance Training + DietBehavioural

    Also called RT+CR

    3 d/w resistance training plus 600 kcal/d deficit

Study groups in NCT01049698
Study groupRoleWhat they receive
1. Resistance TrainingActive comparator3 d/wk resistance training
Receives: Behavioral: Resistance Training
2. Resistance Training + DietExperimentalResistance training plus caloric restriction
Receives: Behavioral: Resistance Training + Diet

What is being measured

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

  1. Skeletal muscle function (muscle quality and muscle power) and overall physical function (SPPB score)

    Measured: 5 month study with baseline and 5 and 18 month follow up assessment visits

Secondary outcomes (1)

  1. single-fiber contractile force and power, intramyocellular lipid (IMCL), muscle gene and protein expression of interleukin-6 (IL-6) and tumor necrosis factor alpha.

    Measured: baseline and 5 and 18-month follow-up

Timeline

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

  1. First posted14 Jan 2010 (estimated)
  2. Study startFeb 2010
  3. Primary completionMay 2014
  4. Study completionMay 2014

Resources

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
Single blind
Who is masked
Outcomes assessor
Enrolment
126 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01049698
Sponsor's protocol ID
IRB00009098
Acronym
I'MFIT
Status last verified
Jul 2018
First submitted
11 Jan 2010
Last updated
1 Aug 2018
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: All data will be made available upon email request to the study PI and upon completion of a data-sharing agreement. This agreement will require that data be used only for research purposes, that no attempts be made to identify individual patients, that the data will be kept secure, that the user will not distribute the data to other researchers, that the user will return the files or destroy them once the project is completed, and that the user will acknowledge the data source. All data files will be de-identified. In addition, variables that could permit linkages to individual research participants and variables that could lead to deductive disclosure of the identity of individual subjects will be removed or recoded. We will create a link on our website that describes our study and the data available for data sharing with descriptions.

Publications

  • Bharadwaj MS, Tyrrell DJ, Leng I, Demons JL, Lyles MF, Carr JJ, Nicklas BJ, Molina AJ. Relationships between mitochondrial content and bioenergetics with obesity, body composition and fat distribution in healthy older adults. BMC Obes. 2015 Oct 6;2:40. doi: 10.1186/s40608-015-0070-4. eCollection 2015.

    PubMed 26448868

  • Jefferson ME, Nicklas BJ, Chmelo EA, Crotts CI, Shaltout HA, Diz DI, Marsh AP, Brinkley TE. Effects of Resistance Training With and Without Caloric Restriction on Arterial Stiffness in Overweight and Obese Older Adults. Am J Hypertens. 2016 Apr;29(4):494-500. doi: 10.1093/ajh/hpv139. Epub 2015 Aug 20.

    PubMed 26297029

  • Nicklas BJ, Chmelo E, Delbono O, Carr JJ, Lyles MF, Marsh AP. Effects of resistance training with and without caloric restriction on physical function and mobility in overweight and obese older adults: a randomized controlled trial. Am J Clin Nutr. 2015 May;101(5):991-9. doi: 10.3945/ajcn.114.105270. Epub 2015 Mar 11.

    PubMed 25762810

Questions about this trial

What is this clinical trial studying?

A study testing Resistance Training and Resistance Training + Diet in people with Obesity, run by Wake Forest University 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 8 inclusion and 12 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 1 Aug 2018. 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?

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.

What does the primary outcome measure?

Skeletal muscle function (muscle quality and muscle power) and overall physical function (SPPB score) (time frame: 5 month study with baseline and 5 and 18 month follow up assessment visits). 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 NCT01049698, which also lists 3 linked publications.

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 1 Aug 2018.

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Improving Muscle for Functional Independence Trial | AzTrials