Exercise and Weight Loss in PAD
Nyckelord
Abstrakt
Beskrivning
Peripheral artery disease (PAD) affects an estimated 12 -15 million adults in the US and an estimated 20% of older Veterans. Those with PAD ambulate with slow gait and experience decreased leg strength, dysmobility, reduced quality of life, serious morbidity and often premature death. It is estimated that over 60% of individuals with PAD are overweight or obese. While PAD itself worsens mobility, obesity adds a further functional burden to older adults with PAD. Individuals diagnosed with PAD, who are also obese typically claudicate 40% more quickly than non-obese individuals and take 20% longer to recover after claudication. Studies of older obese adults without PAD have demonstrated that the combination of exercise and weight loss is more effective at improving physical function and body composition than exercise alone. While these findings likely translate to older adults with PAD, this hypothesis has yet to be tested. This study is designed to determine whether weight loss and exercise (WL+EX) versus exercise ( EX ) alone will 1) improve mobility function (walking ability) to a greater extent than exercise alone and 2) determine the mechanisms underlying changes in mobility function by measuring muscle microvascular perfusion and composition. The investigators hypothesize that a combined intervention of weight loss and exercise (aerobic and restive) will result in greater improvements in mobility function through improved muscle perfusion and reduced muscle fat infiltration than exercise alone in obese Veterans with PAD.
Datum
Senast verifierad: | 03/31/2020 |
Först skickat: | 11/12/2015 |
Beräknad anmälan inlämnad: | 11/12/2015 |
Först publicerad: | 11/16/2015 |
Senaste uppdatering skickad: | 04/01/2020 |
Senaste uppdatering publicerad: | 04/05/2020 |
Faktiskt startdatum för studien: | 09/30/2015 |
Uppskattat primärt slutdatum: | 03/31/2021 |
Beräknat slutfört datum: | 03/31/2022 |
Tillstånd eller sjukdom
Intervention / behandling
Other: Exercise
Other: Exercise and Weight Loss
Fas
Armgrupper
Ärm | Intervention / behandling |
---|---|
Experimental: Exercise and Weight Loss Individuals assigned to this group will be asked to complete both the exercise and weight loss intervention for six months | Other: Exercise and Weight Loss Individuals will be asked to meet with a registered dietitian once a week to discuss strategies to reduce daily caloric intake to gradually reduce body weight over 6 months. |
Active Comparator: Exercise Individuals assigned to this group will be asked to complete the exercise intervention for xic months |
Urvalskriterier
Åldrar berättigade till studier | 60 Years Till 60 Years |
Kön som är berättigade till studier | All |
Accepterar friska volontärer | Ja |
Kriterier | Inclusion Criteria: - BMI >30 kg/m2 - ABI <.90 - Able to participate in a supervised exercise program at the Baltimore VA - No current plan for surgical revascularization - Claudication or leg symptoms when walking Exclusion Criteria: - Unstable angina or a recent heart attack - Active cancer - Dementia - Current foot or leg ulcers - Already exercise 2x/week or more. |
Resultat
Primära resultatåtgärder
1. Difference in time to onset of calf pain (Claudication Onset Time) pre-intervention to post-intervention [6 months]
2. Difference in ankle brachial index pre-intervention to post-intervention [6 months]
Sekundära resultatåtgärder
1. Difference in Modified Physical Performance Test scores pre-intervention to post-intervention [6 months]
2. Change in muscle composition of the calf muscles pre-intervention to post-intervention [6 months]