Clinical trial NCT03722797: Physical Activity in Adults With Amputation
Official title: Metabolic Cost and Physical Activity in Sedentary Adults With a Unilateral Transtibial Amputation as Compared to Controls
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Amputees
Keywords: energy metabolism
walking
exercise
Lead sponsor: University of Delaware
Sponsor class: OTHER
First posted: 2018-10-29
Enrollment: 3
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Investigators will recruit 22 (males and females) with a unilateral (i.e. single limb), transtibial (i.e. below-the-knee) amputation. Given the prevalence of amputations is greater in males, it is expected that the sample will be predominantly male, but there will not be any inclusion/exclusion criteria related to sex. 20 controls will be recruited as age-, sex-, and body mass index-matched controls for those with a unilateral transtibial amputation who complete the entire study evaluation protocol.

Brief summary: This cross-sectional study explores physical activity and energy expenditure among inactive adults with a unilateral transtibial amputation. Results may assist with physical activity prescription for adults with unilateral lower-limb loss.

Detailed description: Up to 48% of adults following a lower-limb amputation will die within the upcoming year. Lack of physical activity (exercise) contributes to high death rates. It is recommended that younger (and middle-aged) adults without a health condition walk 10,000 steps/day to reduce the risk of chronic health conditions, while recommendations are 7,100 steps per day for older adults and those with chronic health conditions. Adults with a lower-limb amputation walking about 21-43% of the recommended 7,100 steps/day. Step activity monitors, such as the StepWatch (a research-grade accelerometer) and the FitBit (a commercially-available monitor) provide a means of evaluating physical activity, which is important since patients tend to over-estimate their level of physical activity. Activity monitor use, however, may not be possible in every healthcare practice setting, as monitors may cost $100-$600 and someone must remove the data from the monitor, interpret the data, and enter the data into the patient's medical record. Therefore, physical activity questionnaires, where the patient self-reports their physical activity, are ideal in a clinical setting. Unfortunately, to date, there has been little research looking at the accuracy of physical activity questionnaires in patients with lower-limb amputations and how these questionnaires measure up to data obtained from step activity monitors.

In addition to 7,100 steps/day, adults with mobility-limiting, chronic conditions (including individuals with lower-limb amputations) should participate in ≥150 minutes of moderate-intensity physical activity per week, with activity in ≥10 minutes per bout. Moderate-intensity activity has been defined as 3 metabolic equivalents (METs). One MET is equal to the amount of oxygen one consumes at rest, so 3 METs means that one is consuming 3 times the amount of oxygen one would consume at rest. In healthy adults without a medical condition this equates to walking 2.6-2.7 mph or 100 steps/minute, while for adults with an amputation of the leg below-the-knee (i.e. a transtibial amputation), 1.47 mph or 86 steps/minute has been reported to equal 3 METs. Maximal walking speeds for adults with lower-limb amputations, specifically those who have lost their limb due to poor blood circulation may be ≤1.67 mph, so one must question if walking 1.47 mph for an extended time is possible for these patients. Investigators believe that 1.47mph is greater than 3 METs for adults with a lower-limb amputation who have other medical issues, such as diabetes and peripheral vascular disease, and who are deconditioned and not participating in physical activity.

It is important to know what speed (mph) and cadence (steps/minute) equals 3 METs in adults with a lower-limb amputation with other medical conditions who are currently inactive. Investigators believe that these patients represent the vast majority of patients that healthcare providers encounter and must council regarding increasing physical activity levels. Providers need to know what speed and cadence is equal to 3 METs for inactive patients with limb loss with other medical conditions, so that providers can appropriately advise their patients and prescribe exercise.

Walking exercise may occur over-ground or on a treadmill. When an individual with a lower-limb amputation is walking over-ground, their right-to-left side walking pattern will be more asymmetrical (uneven) when compared to when they are walking on a treadmill. When walking is more symmetrical side-to-side (even), the patient may have to expend more energy. Energy expenditure can be assessed as the amount of oxygen consumed, which can be obtained while wearing a mask that evaluates the participant's breathing while walking. Among adults with a lower-limb amputation, energy expenditure studies have generally used treadmills to look at energy expenditure. Over-ground versus treadmill conditions, however, are different, and as such, what equals 3 METs (speed, cadence) in each walking condition may vary.

Further, no studies have compared the energy cost of walking in adults who are inactive with a lower-limb amputation to age-, sex-, and body mass index (computed from height and weight) -matched adults without an amputation. While studies have evaluated the impact of aging and limb length of the amputated limb on energy expenditure, few have evaluated modifiable factors that may impact energy expenditure among adults with lower-limb amputation. Similarly, little research has explored modifiable factors that may impact physical activity levels.

The project's goal is to provide knowledge that will improve physical activity prescription for inactive adults with a single, below-the-knee amputation (i.e. transtibial amputation).

Successful completion of the project may provide healthcare providers with (1) a physical activity self-report measure that can be used in clinical practice for patients with a lower-limb amputation, (2) gait speed (mph) for prescribing moderate-intensity over-ground and treadmill walking during the rehabilitation of patients with lower-limb amputations, and (3) cadence (steps/minute), for evaluating and monitoring moderate-intensity physical activity via step activity monitors, for inactive adults with a lower-limb amputation.

Investigators will provide the first objective data that looks at the additional energy expenditure necessary for inactive adults with a lower-limb amputation who are using a prosthesis to walk short-distances as compared to able-bodied adults; this data may be used for the development of future prosthetic components that reduce energy expenditure. Investigators will explore factors that may be linked to energy expenditure and physical activity among adults with and without a lower-limb amputation.

Eligibility criteria: Inclusion Criteria (all participants):

* Ages 18-60 years
* Able to read and speak English
* Saltin-Grimby Physical Activity Level of I or II

Inclusion Criteria (individuals with unilateral, transtibial amputations):

* Unilateral, transtibial (below-the-knee) amputation
* Currently wearing a prosthesis with use of an assistive device no greater than a cane
* Wearing prosthetic at least 8 hours per day and inside and outside the home: This criteria will help to ensure that adults are beyond the initial weaning into a prosthetic period and are prosthetic users rather than nonusers.

Inclusion Criteria (controls):

* Pain-free in the legs and low back regions
* Able to walk without an assistive device

Exclusion Criteria:

* Current infections or illnesses that would affect safe participation in the study
* Past medical history of significant cardiovascular disease (e.g. congestive heart failure or previous heart attacks), significant neurological disease (e.g. Parkinson's, Multiple Sclerosis) significant neurological event (e.g. stroke), or major lung condition (e.g. Chronic obstructive pulmonary disease, emphysema)
* Uncontrolled high blood pressure
* Uncontrolled Diabetes Mellitus

Primary outcomes:
measure: Change in gait speed pre- and post-walking tests
timeFrame: immediately before/after
Secondary outcomes:
measure: Change in gait symmetry
timeFrame: immediately before/after
Other outcomes:
Locations:
city: Newark
country: United States
facility: University of Delaware STAR Campus
state: Delaware
Study officials:
affiliation: University of Delaware
name: Jaclyn M Sions, PhD, PT, DPT
role: PRINCIPAL_INVESTIGATOR
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