Please select the arm or intervention descriptions that belong to the clinical trial below.
Title: Feet First: Increasing Activity Without Increasing the Risk of Foot Ulcers in People With Diabetes and Insensate Feet
Brief Summary: The role of weight-bearing physical activity in the development of diabetic foot ulcers remains poorly understood. Regular participation in moderately intense physical activity (e.g. brisk walking ) reduces 8-year cardiovascular mortality in those with diabetes mellitus by over 30%. The American Diabetes Association (ADA) recommends at least 30 minutes of daily moderate intensity activity for people with diabetes. However, the ADA recommends that people with diabetes and insensate feet, which affects up to 40% of those with diabetes, should limit their walking because of concerns that walking could increase the risk of foot ulcers and amputation. Firm evidence is lacking to support these concerns; in fact, while a research fellow I conducted an observational study that showed daily weight-bearing activity may reduce the risk of foot ulceration among people with diabetic foot problems. A controlled clinical trial is needed to study these issues further.

The present study is a randomized controlled trial in 100 older adults with diabetes and insensate feet, 50 of whom will participate in an individually-tailored behavior-change intervention called "Feet First", and 50 of whom will be controls. The intervention is based on the extensively-tested CHAMPS model used by the Robert Wood Johnson Foundation's Active for Life Program. Feet First extends the target population beyond older adults generally to people with insensate feet due to diabetic peripheral neuropathy.

The specific aims of the study are:

* To determine whether Feet First intervention subjects achieve a greater increase in weight-bearing activity than control subjects, and
* To obtain preliminary evidence on intervention subjects' foot outcomes (foot function, foot-related self-care, and risk of foot ulcers), compared to control subjects.


Options:
A: Arm Label: Feet First; Type: EXPERIMENTAL; Interventions: Behavioral: Feet First | Arm Label: Control; Type: NO_INTERVENTION; Interventions: N/A | Intervention Type: BEHAVIORAL; Name: Feet First; Assigned to Arm(s): Feet First
B: Arm Label: Standard Care Counseling; Type: EXPERIMENTAL; Interventions: Behavioral: Standard Care Counseling | Arm Label: Supervised Exercise and Counseling; Type: EXPERIMENTAL; Interventions: Behavioral: Supervised Exercise and Counseling | Intervention Type: BEHAVIORAL; Name: Standard Care Counseling; Assigned to Arm(s): Standard Care Counseling | Intervention Type: BEHAVIORAL; Name: Supervised Exercise and Counseling; Assigned to Arm(s): Supervised Exercise and Counseling
C: Arm Label: Control; Type: NO_INTERVENTION; Interventions: N/A | Arm Label: Intervention; Type: EXPERIMENTAL; Interventions: Other: Pulmonary Rehabilitation | Intervention Type: OTHER; Name: Pulmonary Rehabilitation; Assigned to Arm(s): Intervention
D: Arm Label: IVR Intervention Group; Type: EXPERIMENTAL; Interventions: Behavioral: IVR Intervention Group | Arm Label: IVR Control Group; Type: NO_INTERVENTION; Interventions: N/A | Intervention Type: BEHAVIORAL; Name: IVR Intervention Group; Assigned to Arm(s): IVR Intervention Group

Answer: A