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Clinical Trials/NCT01112709
NCT01112709CompletedPhase 2

Maintaining Resistance Training in Older Prediabetic Adults: Theoretical Approach

Virginia Polytechnic Institute and State University2 sites in 1 country170 target enrollmentStarted: January 1, 2011Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Phase 2
Status
Completed
Enrollment
170
Locations
2
Primary Endpoint
Markers of prediabetes

Study Overview

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 Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Prevention
Masking
Single (Participant)

Eligibility Criteria

Ages
50 Years to 69 Years (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

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),
  • •uncontrolled hypertension,
  • •retinopathy,
  • •recent cataract surgery,
  • •recent head trauma.

Arms & Interventions

SCT

Experimental

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.

Intervention: SCT-based Resistance Training exercise program (Behavioral)

Control

Active Comparator

This arm will be the "control" condition; a Standard intervention with minimal contact.

Intervention: Standard Intervention with minimal contact (Other)

Outcomes

Primary Outcomes

Markers of prediabetes

Time Frame: 15 months

glucose tolerance and fasting glucose concentration

Muscular Strength

Time Frame: 15 months

3 RM (repetition maximum - the maximum amount of weight that can be lifted three times)

Secondary Outcomes

  • 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)

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Brenda Davy

Associate Professor

Virginia Polytechnic Institute and State University

Study Sites (2)

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