Maintaining Resistance Training in Older Prediabetic Adults

Phase 2

Completed

• Conditions: Diabetes; Prediabetes
• Interventions: Behavioral: SCT-based Resistance Training exercise program; Other: Standard Intervention with minimal contact

• Registration Number: NCT01112709
• Lead Sponsor: Virginia Polytechnic Institute and State University

Brief 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.

Detailed 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.

Study Timeline

• Study First Submitted: 2010-04-22
• Study First Submitted QC: 2010-04-27
• Study First Posted: 2010-04-28
• Study Start: 2011-01
• Status Verified: 2014-03
• Primary Completion: 2014-03
• Study Completion: 2014-03
• Last Update Submitted: 2014-03-19
• Last Update Posted: 2014-03-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 170

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).

Read More

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.

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
SCT	SCT-based Resistance Training exercise program	This arm is a long-term, Social Cognitive Theory (SCT)-based intervention, emphasizing self-regulation and other SCT strategies to optimize training, with faded contact.
Control	Standard Intervention with minimal contact	This arm will be the "control" condition; a Standard intervention with minimal contact.

Primary Outcome Measures

Name	Time	Method
Markers of prediabetes	15 months	glucose tolerance and fasting glucose concentration
Muscular Strength	15 months	3 RM (repetition maximum - the maximum amount of weight that can be lifted three times)

Secondary Outcome Measures

Name	Time	Method
Insulin secretion and action	15 Months
Adherence to the resistance training program session schedule (twice/week sessions)	15 Months
Social Cognitive Theory Measures (includes self-efficacy, self-regulation, outcome expectancies, and affect; related to resistance training)	15 Months
Body Composition	15 Months

Trial Locations

Locations (2)

VT Riverside; 🇺🇸 Roanoke, Virginia, United States

Virginia Tech; 🇺🇸 Blacksburg, Virginia, United States