Improving Muscle for Functional Independence Trial

NCT01049698 | Completed DMC

• 1 other identifier: IRB00009098
• Study Type: interventional
• Target: 126
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Obesity

Keywords

Obesity; Overweight; Older adults; resistance training; exercise

Outcome Measures

Primary Outcomes (1)

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

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

Secondary Outcomes (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.

  baseline and 5 and 18-month follow-up

Study Arms (2)

1. Resistance Training

ACTIVE COMPARATOR

3 d/wk resistance training

Behavioral: Resistance Training

2. Resistance Training + Diet

EXPERIMENTAL

Resistance training plus caloric restriction

Behavioral: Resistance Training + Diet

Interventions

Resistance Training BEHAVIORAL

3 d/wk resistance training

Also known as: RT, Nautilus resistance machines

1. Resistance Training

Resistance Training + Diet BEHAVIORAL

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

Also known as: RT+CR

2. Resistance Training + Diet

Eligibility Criteria

• Age: 65 Years - 79 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• Wake Forest University: lead

Study Sites (1)

Wake Forest University Health Sciences

Winston-Salem, North Carolina, 27157, United States

Location

Related Publications (3)

• 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.

  PMID: 26448868 DERIVED

• 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.

  PMID: 26297029 DERIVED

• 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.

  PMID: 25762810 DERIVED

MeSH Terms

Conditions

Obesity; Overweight; Motor Activity

Interventions

Resistance Training; Diet

Condition Hierarchy (Ancestors)

Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Behavior

Intervention Hierarchy (Ancestors)

Exercise Therapy; Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Therapeutics; Physical Therapy Modalities; Physical Conditioning, Human; Exercise; Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena; Nutritional Physiological Phenomena; Diet, Food, and Nutrition; Physiological Phenomena

Study Officials

• Barbara J Nicklas, PhD

  Wake Forest University Health Sciences

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 11, 2010
• First Posted: January 14, 2010
• Study Start: February 1, 2010
• Primary Completion: May 1, 2014
• Study Completion: May 1, 2014
• Last Updated: August 1, 2018

Record last verified: 2018-07

Data Sharing

• IPD Sharing: Will share

Locations

US (1)