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| ID | Type | Description | Link |
|---|---|---|---|
| IK2RX001788-01 | U.S. NIH Grant/Contract | View source |
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This study is designed to examine the added benefits of weight loss to an exercise program in older obese Veterans with peripheral arterial disease. The investigators want to determine if weight loss in addition to exercise will 1) improve walking ability to a greater extent than exercise alone and 2) determine the underlying reasons why walking ability improves by measuring blood flow and the amount of muscle in the leg muscles.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Exercise and Weight Loss | Experimental | Individuals assigned to this group will be asked to complete both the exercise and weight loss intervention for six months |
|
| Exercise | Active Comparator | Individuals assigned to this group will be asked to complete the exercise intervention for xic months |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Exercise | Other | Individuals will be asked to walk 3 times a week on a treadmill (initially starting at 15 minutes and progressing up to 40 minutes) and participate in a short weight training program focused on increasing strength in the legs. |
| Measure | Description | Time Frame |
|---|---|---|
| Difference in Time to Onset of Calf Pain (Claudication Onset Time) Pre-intervention to Post-intervention | The change in the amount of time it takes for calf pain to first appear while walking on a treadmill comparing pre and post-intervention | 6 months |
| Difference in Ankle Brachial Index Pre-intervention to Post-intervention | A change in the muscle blood flow to the legs determined by taking blood pressure in the arms and legs before and after cessation of exercise comparing the change pre to post exercise scores pre-intervention (baseline) and post intervention (6 months). There are no units because the ankle brachial index is a ratio. An improvement would be a higher number a post-intervention testing than pre-intervention testing. A negative number indicates improvement while a positive number indicates a worse score post-testing. | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Score on the Modified Physical Performance Test Post-intervention | A mobility measure that utilizes 9 tasks scored 0-4 (total possible score 36) to determine functional status. Scores from each of the nine items are summed for the total score. Scores are from 0-36 with higher scores considered to be better. The post-testing median score will be reported for post-testing. | 6 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Odessa R. Addison, PhD DPT | Baltimore VA Medical Center VA Maryland Health Care System, Baltimore, MD | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Baltimore VA Medical Center VA Maryland Health Care System, Baltimore, MD | Baltimore | Maryland | 21201 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Exercise and Weight Loss | Individuals assigned to this group will be asked to complete both the exercise and weight loss intervention for six months Exercise: Individuals will be asked to walk 3 times a week on a treadmill (initially starting at 15 minutes and progressing up to 40 minutes) and participate in a short weight training program focused on increasing strength in the legs. 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. |
| FG001 | Exercise | Individuals assigned to this group will be asked to complete the exercise intervention for xic months Exercise: Individuals will be asked to walk 3 times a week on a treadmill (initially starting at 15 minutes and progressing up to 40 minutes) and participate in a short weight training program focused on increasing strength in the legs. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Exercise and Weight Loss | Individuals assigned to this group will be asked to complete both the exercise and weight loss intervention for six months Exercise: Individuals will be asked to walk 3 times a week on a treadmill (initially starting at 15 minutes and progressing up to 40 minutes) and participate in a short weight training program focused on increasing strength in the legs. 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Difference in Time to Onset of Calf Pain (Claudication Onset Time) Pre-intervention to Post-intervention | The change in the amount of time it takes for calf pain to first appear while walking on a treadmill comparing pre and post-intervention | 6 individuals in the exercise and weight loss group and 2 individuals in the exercise group completed pre/post measures for Claudication onset time | Posted | Median | Full Range | seconds | 6 months |
|
6 months from baseline
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Exercise and Weight Loss | Individuals assigned to this group will be asked to complete both the exercise and weight loss intervention for six months Exercise: Individuals will be asked to walk 3 times a week on a treadmill (initially starting at 15 minutes and progressing up to 40 minutes) and participate in a short weight training program focused on increasing strength in the legs. 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. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Stroke | Nervous system disorders | Non-systematic Assessment | New onset of Cerebrovascular accident (CVA) |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Fall | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
Lower recruitment with an overall small sample size limited the number of participants to be analyzed in the study. An unequal drop out rate between the groups also limits interpretation of data at the six-month time point.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Odessa Addison | Baltimore VA Hosptial | 4106057000 | 55393 | odessa.addison@va.gov |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Apr 12, 2023 | Apr 18, 2023 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D058729 | Peripheral Arterial Disease |
| D009043 | Motor Activity |
| D015431 | Weight Loss |
| D051346 | Mobility Limitation |
| ID | Term |
|---|---|
| D050197 | Atherosclerosis |
| D001161 | Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
| D014652 | Vascular Diseases |
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| ID | Term |
|---|---|
| D015444 | Exercise |
| ID | Term |
|---|---|
| D009043 | Motor Activity |
| D009068 | Movement |
| D009142 | Musculoskeletal Physiological Phenomena |
| D055687 | Musculoskeletal and Neural Physiological Phenomena |
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| Weight Loss | Other | 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. |
|
| Change in Muscle Composition of the Calf Muscles Pre-intervention to Post-intervention | A measure of the amount of muscle and fat in the muscle using a CT scan of the legs. Pre-test levels will be compared to post-test levels. | 6 months |
| BG001 | Exercise | Individuals assigned to this group will be asked to complete the exercise intervention for xic months Exercise: Individuals will be asked to walk 3 times a week on a treadmill (initially starting at 15 minutes and progressing up to 40 minutes) and participate in a short weight training program focused on increasing strength in the legs. |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Median | Full Range | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
| OG001 | Exercise | Individuals assigned to this group will be asked to complete the exercise intervention for xic months Exercise: Individuals will be asked to walk 3 times a week on a treadmill (initially starting at 15 minutes and progressing up to 40 minutes) and participate in a short weight training program focused on increasing strength in the legs. |
|
|
|
| Primary | Difference in Ankle Brachial Index Pre-intervention to Post-intervention | A change in the muscle blood flow to the legs determined by taking blood pressure in the arms and legs before and after cessation of exercise comparing the change pre to post exercise scores pre-intervention (baseline) and post intervention (6 months). There are no units because the ankle brachial index is a ratio. An improvement would be a higher number a post-intervention testing than pre-intervention testing. A negative number indicates improvement while a positive number indicates a worse score post-testing. | 6 individuals in the exercise and weight loss group and 2 individuals in the exercise group completed pre/post measures for ankle brachial index | Posted | Median | Full Range | ratio | 6 months |
|
|
|
| Secondary | Score on the Modified Physical Performance Test Post-intervention | A mobility measure that utilizes 9 tasks scored 0-4 (total possible score 36) to determine functional status. Scores from each of the nine items are summed for the total score. Scores are from 0-36 with higher scores considered to be better. The post-testing median score will be reported for post-testing. | Posted | Median | Full Range | score on a scale | 6 months |
|
|
|
| Secondary | Change in Muscle Composition of the Calf Muscles Pre-intervention to Post-intervention | A measure of the amount of muscle and fat in the muscle using a CT scan of the legs. Pre-test levels will be compared to post-test levels. | This measure was not conducted due to staffing and pandemic related limitations in acquiring the CT scans. | Posted | 6 months |
|
|
| 0 |
| 9 |
| 2 |
| 9 |
| 4 |
| 9 |
| EG001 | Exercise | Individuals assigned to this group will be asked to complete the exercise intervention for xic months Exercise: Individuals will be asked to walk 3 times a week on a treadmill (initially starting at 15 minutes and progressing up to 40 minutes) and participate in a short weight training program focused on increasing strength in the legs. | 0 | 9 | 3 | 9 | 2 | 9 |
|
| angina | Cardiac disorders | Non-systematic Assessment |
|
| Coronary Artery Bypass Graft (CABG) | Cardiac disorders | Non-systematic Assessment |
|
| Gastrointestinal (GI) bleed | Gastrointestinal disorders | Non-systematic Assessment |
|
| Infection | Infections and infestations | Non-systematic Assessment |
|
| Car accident | Social circumstances | Non-systematic Assessment |
|
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| D002318 |
| Cardiovascular Diseases |
| D016491 | Peripheral Vascular Diseases |
| D001519 | Behavior |
| D001836 | Body Weight Changes |
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |