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Maintaining Resistance Training in Older Prediabetic Adults

Maintaining Resistance Training in Older Prediabetic Adults: Theoretical Approach

Status
Completed
Phases
Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01112709
Enrollment
170
Registered
2010-04-28
Start date
2011-01-31
Completion date
2014-03-31
Last updated
2014-03-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diabetes, Prediabetes

Keywords

Diabetes, Prediabetes, Resistance training, behavior, behavioral change theory

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.

Interventions

BEHAVIORALSCT-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.

OTHERStandard 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.

Sponsors

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

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Subject)

Eligibility

Sex/Gender
ALL
Age
50 Years to 69 Years
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), * smokers, * uncontrolled hypertension, * retinopathy, * recent cataract surgery, * recent head trauma.

Design outcomes

Primary

MeasureTime frameDescription
Markers of prediabetes15 monthsglucose tolerance and fasting glucose concentration
Muscular Strength15 months3 RM (repetition maximum - the maximum amount of weight that can be lifted three times)

Secondary

MeasureTime frame
Insulin secretion and action15 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 Composition15 Months

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 2, 2026