Maintaining Resistance Training in Older Prediabetic Adults

Diabetes Clinical Trial

Official title:

Maintaining Resistance Training in Older Prediabetic Adults: Theoretical Approach

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01112709
• Other study ID #: 1R01DK082383-01A1
• Secondary ID: R01DK082383
• Status: Completed
• Phase: Phase 2
• First received: April 22, 2010
• Last updated: March 19, 2014
• Start date: January 2011
• Est. completion date: March 2014

Study information

• Verified date: March 2014
• Source: Virginia Polytechnic Institute and State University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

The aim of this Phase II Clinical Trial is to demonstrate the efficacy of social cognitive theory (SCT) based intervention for initiating, and most importantly, maintaining resistance training in older adults with pre-diabetes (i.e., impaired glucose tolerance or impaired fasting glucose) to improve blood glucose regulation.

Description:

The aim of this Phase II Clinical Trial is to demonstrate the efficacy of social cognitive theory (SCT) based intervention for initiating, and most importantly, maintaining resistance training in older adults with pre-diabetes (i.e., impaired glucose tolerance or impaired fasting glucose) to improve glucose homeostasis. The overall aim is consistent with NIDDK's Behavioral/Prevention Research Program's focus on individual, family, and community-based strategies for prevention of diabetes and its complications. Resistance training is particularly applicable to older, pre-diabetic adults given the loss of lean body mass and worsening of glucose tolerance with aging. The proposed research program evaluates a 15-month SCT based intervention for maintenance of resistance training with older adults. Men and women 50-69 (N=180) with pre-diabetes, defined as exhibiting either impaired glucose tolerance (IGT; 2-h glucose 140-199 mg/dl) or impaired fasting glucose (IFG; 100-125 mg/dl), will first follow the same standard, supervised 3-month initiation period with resistance training. All people completing the Initial Phase will be randomly assigned to 1 of 2 maintenance conditions: 1. a long-term SCT based, ASPIRE intervention, emphasizing self-regulation and other SCT strategies to optimize training, with faded contact; 2. a Standard intervention with minimal contact. The primary outcome measures are indices of pre-diabetes (glucose tolerance and fasting glucose concentration) and strength. Secondary measures include adherence; ß-cell responsivity, insulin sensitivity, and disposition index, as determined by the oral glucose and C-peptide minimal model; fat free mass, other indicators of health and metabolic fitness, and SCT measures. Assessments will occur at baseline, at the end of the Initiation Phase (3 months), at the end of the different interventions (9 months) and 6 months after all contact has ended (15 months from baseline). It is hypothesized that SCT based resistance training with faded contact will produce better outcomes than the Standard-based resistance training at 9 month and 15 month assessments. It also is hypothesized that improvements in glucose homeostasis and in strength from resistance training will be mediated by adherence, self-efficacy, and use of self-regulation strategies. Resistance training has become an important component in the treatment and prevention of diseases and disabilities, and especially so for Type 2 diabetes. Critical to public health and a focus of NIDDK are theory-based interventions that enable, effective long-term resistance training with minimal supervision after an initiation phase and where improvements in adherence and outcomes are facilitated by theoretical constructs.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 170
• Est. completion date: March 2014
• Est. primary completion date: March 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 50 Years to 69 Years

Eligibility

Inclusion Criteria:

• prediabetes,

• overweight or obese,

• aged 50-69 years,

• otherwise good health,

• physician clearance for exercising,

• sedentary (< 150 min/wk of moderate intensity physical activity).

Exclusion Criteria:

• diagnosed with diabetes or other conditions that would preclude an individual from safely resistance training (eg, heart disease),

• currently engaging in RT (for > 1 year),

• smokers,

• uncontrolled hypertension,

• retinopathy,

• recent cataract surgery,

• recent head trauma.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Diabetes
• Glucose Intolerance
• Prediabetes
• Prediabetic State

Intervention

Behavioral:
• SCT-based Resistance Training exercise program
Two supervised RT sessions per week for the first 3 months, then a self-monitored RT phase for the remainder of the study, with primarily Internet-based contact.

Other:
• Standard Intervention with minimal contact
This is the control condition for comparison; the approach will be identical to the experimental condition, but without the theoretical components (skills to increase self efficacy for RT, self regulation for RT). Contact with the study staff will be reduced from that received by the experimental group.

Locations

Country	Name	City	State
United States	Virginia Tech	Blacksburg	Virginia
United States	VT Riverside	Roanoke	Virginia

Sponsors (2)

Lead Sponsor	Collaborator
Virginia Polytechnic Institute and State University	National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Markers of prediabetes	glucose tolerance and fasting glucose concentration	15 months	No
Primary	Muscular Strength	3 RM (repetition maximum - the maximum amount of weight that can be lifted three times)	15 months	No
Secondary	Insulin secretion and action		15 Months	No
Secondary	Adherence to the resistance training program session schedule (twice/week sessions)		15 Months	No
Secondary	Social Cognitive Theory Measures (includes self-efficacy, self-regulation, outcome expectancies, and affect; related to resistance training)		15 Months	No
Secondary	Body Composition		15 Months	No