AmputeesNCT03722797
Physical Activity in Adults With Amputation
An observational study of Amputees, run by University of Delaware at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Amputees
- What is being tested?
- Metabolic Cost Testing Procedures
- Type of treatment
- Surgery or procedure
- How many people
- 3 participants
- Where
- 1 siteUnited States
- Study dates
- 11 May 2017to 17 Feb 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
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.
Who may be able to join
- 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
Show all 9Show fewer
- 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.
- Pain-free in the legs and low back regions
- Able to walk without an assistive device
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Delaware STAR Campus
Newark, Delaware, 19713
About this study
Official title: Metabolic Cost and Physical Activity in Sedentary Adults With a Unilateral Transtibial Amputation as Compared to Controls
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.
Read the 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.
- Conditions
- Amputees
- Being tested
- Metabolic Cost Testing Procedures
- Keywords
- energy metabolism, walking, exercise
- Medical subject headings
- Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Metabolic Cost Testing ProceduresProcedure or surgery
The Oxycon Mobile™Portable VO2 Measurement system will be used to measure VO2 uptake during 2 walking tests. Test order will be randomized.
Treadmill Test: Participants will walk on a treadmill at constant speed, based on the participant's self-selected gait speed, for 2.5 minutes in each stage. Walking will occur at 75% of self-selected gait speed in stage 1, 100% in stage 2, and 125% in stage 3.
Over-ground Test: Participants will walk in an uncarpeted corridor on a course consisting of 2 cones, 20-meters apart. Participants will be instructed to walk at a constant speed for 2.5 minutes in each stage. Instructions will be to walk at their "slow" speed in stage 1, their "usual, comfortable" speed in stage 2, and their "brisk" speed in stage 3.
| Study group | Role | What they receive |
|---|---|---|
| Unilateral Transtibial Amputation | Individuals with a unilateral, transtibial amputation. Receives: Procedure: Metabolic Cost Testing Procedures | |
| Controls | Healthy adults without a lower-limb amputation who have been matched to participants in the Unilateral Transtibial Amputation group based on age, sex, and body mass index. Receives: Procedure: Metabolic Cost Testing Procedures |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in gait speed pre- and post-walking tests
self-selected and fast speeds obtained with GaitRite
Measured: immediately before/after
Secondary outcomes (1)
Change in gait symmetry
Temporal and spatial gait characteristics obtained with GaitRite
Measured: immediately before/after
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Oct 2018
- Study start11 May 2017
- Primary completion17 Feb 2022
- Study completion17 Feb 2022
Why it stopped: Equipment used for metabolic testing is no longer serviced and/or supported by the company. Alternative equipment is not available to the research team to continue to conduct the study.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (57)Papers the sponsor has linked to this study.
- Other trials for AmputeesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 3 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Delaware
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jaclyn Sions, University of Delaware
- Investigators
- Jaclyn M Sions, PhD, PT, DPT, Principal investigator, University of Delaware
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03722797
- Sponsor's protocol ID
- 1046346
- Status last verified
- Feb 2022
- First submitted
- 1 May 2018
- Last updated
- 4 Mar 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Swaminathan A, Vemulapalli S, Patel MR, Jones WS. Lower extremity amputation in peripheral artery disease: improving patient outcomes. Vasc Health Risk Manag. 2014 Jul 16;10:417-24. doi: 10.2147/VHRM.S50588. eCollection 2014.
PubMed 25075192Schuch F, Vancampfort D, Firth J, Rosenbaum S, Ward P, Reichert T, Bagatini NC, Bgeginski R, Stubbs B. Physical activity and sedentary behavior in people with major depressive disorder: A systematic review and meta-analysis. J Affect Disord. 2017 Mar 1;210:139-150. doi: 10.1016/j.jad.2016.10.050. Epub 2016 Nov 29.
PubMed 28033521Shuval K, Leonard T, Drope J, Katz DL, Patel AV, Maitin-Shepard M, Amir O, Grinstein A. Physical activity counseling in primary care: Insights from public health and behavioral economics. CA Cancer J Clin. 2017 May 6;67(3):233-244. doi: 10.3322/caac.21394. Epub 2017 Feb 15.
PubMed 28198998Tudor-Locke C, Bassett DR Jr. How many steps/day are enough? Preliminary pedometer indices for public health. Sports Med. 2004;34(1):1-8. doi: 10.2165/00007256-200434010-00001.
PubMed 14715035Klute GK, Berge JS, Orendurff MS, Williams RM, Czerniecki JM. Prosthetic intervention effects on activity of lower-extremity amputees. Arch Phys Med Rehabil. 2006 May;87(5):717-22. doi: 10.1016/j.apmr.2006.02.007.
PubMed 16635636Halsne EG, Waddingham MG, Hafner BJ. Long-term activity in and among persons with transfemoral amputation. J Rehabil Res Dev. 2013;50(4):515-30. doi: 10.1682/jrrd.2012.04.0066.
PubMed 23934872Desveaux L, Goldstein RS, Mathur S, Hassan A, Devlin M, Pauley T, Brooks D. Physical Activity in Adults with Diabetes Following Prosthetic Rehabilitation. Can J Diabetes. 2016 Aug;40(4):336-41. doi: 10.1016/j.jcjd.2016.02.003. Epub 2016 Apr 1.
PubMed 27052673Thyregod M, Bodtger U. Coherence between self-reported and objectively measured physical activity in patients with chronic obstructive lung disease: a systematic review. Int J Chron Obstruct Pulmon Dis. 2016 Nov 25;11:2931-2938. doi: 10.2147/COPD.S116422. eCollection 2016.
PubMed 27932873Prince SA, Adamo KB, Hamel ME, Hardt J, Connor Gorber S, Tremblay M. A comparison of direct versus self-report measures for assessing physical activity in adults: a systematic review. Int J Behav Nutr Phys Act. 2008 Nov 6;5:56. doi: 10.1186/1479-5868-5-56.
PubMed 18990237Rowe DA, McMinn D, Peacock L, Buis AW, Sutherland R, Henderson E, Hewitt A. Cadence, energy expenditure, and gait symmetry during music-prompted and self-regulated walking in adults with unilateral transtibial amputation. J Phys Act Health. 2014 Feb;11(2):320-9. doi: 10.1123/jpah.2012-0056. Epub 2013 Jan 30.
PubMed 23364470Tudor-Locke C, Sisson SB, Collova T, Lee SM, Swan PD. Pedometer-determined step count guidelines for classifying walking intensity in a young ostensibly healthy population. Can J Appl Physiol. 2005 Dec;30(6):666-76. doi: 10.1139/h05-147.
PubMed 16485518Tudor-Locke C, Rowe DA. Using cadence to study free-living ambulatory behaviour. Sports Med. 2012 May 1;42(5):381-98. doi: 10.2165/11599170-000000000-00000.
PubMed 22462794Waters RL, Perry J, Antonelli D, Hislop H. Energy cost of walking of amputees: the influence of level of amputation. J Bone Joint Surg Am. 1976 Jan;58(1):42-6.
PubMed 1249111Tekin L, Safaz Y, Goktepe AS, Yazycyodlu K. Comparison of quality of life and functionality in patients with traumatic unilateral below knee amputation and salvage surgery. Prosthet Orthot Int. 2009 Mar;33(1):17-24. doi: 10.1080/03093640802482542.
PubMed 19235062Akarsu S, Tekin L, Safaz I, Goktepe AS, Yazicioglu K. Quality of life and functionality after lower limb amputations: comparison between uni- vs. bilateral amputee patients. Prosthet Orthot Int. 2013 Feb;37(1):9-13. doi: 10.1177/0309364612438795. Epub 2012 Jul 24.
PubMed 22833517
Study at a glance
From the registry record, last updated by the sponsor on 4 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Metabolic Cost and Physical Activity in Sedentary Adults With a Unilateral Transtibial Amputation as Compared to Controls
- ClinicalTrials.gov ID
- NCT03722797
- Acronym / sponsor ID
- 1046346
- Conditions
- Amputees
- Keywords
- energy metabolism, walking, exercise
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Equipment used for metabolic testing is no longer serviced and/or supported by the company. Alternative equipment is not available to the research team to continue to conduct the study.
- Enrolment
- 3 participants (actual)
- Lead sponsor
- University of DelawareUniversity, hospital or other
- Study start
- 11 May 2017 (actual)
- Primary completion
- 17 Feb 2022 (actual)
- Study completion
- 17 Feb 2022 (actual)
- First posted
- 29 Oct 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Unilateral Transtibial Amputation | – | Procedure: Metabolic Cost Testing ProceduresIndividuals with a unilateral, transtibial amputation. |
| Controls | – | Procedure: Metabolic Cost Testing ProceduresHealthy adults without a lower-limb amputation who have been matched to participants in the Unilateral Transtibial Amputation group based on age, sex, and body mass index. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- 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.
Key inclusion criteria (9 listed)
- Ages 18-60 years
- Able to read and speak English
- Saltin-Grimby Physical Activity Level of I or II
- Unilateral, transtibial (below-the-knee) amputation
- Currently wearing a prosthesis with use of an assistive device no greater than a cane
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Metabolic Cost Testing ProceduresThe Oxycon Mobile™Portable VO2 Measurement system will be used to measure VO2 uptake during 2 walking tests. Test order will be randomized. Treadmill Test: Participants will walk on a treadmill at constant speed, based on the participant's self-selected gait speed, for 2.5 minutes in each stage. Walking will occur at 75% of self-selected gait speed in stage 1, 100% in stage 2, and 125% in stage 3. Over-ground Test: Participants will walk in an uncarpeted corridor on a course consisting of 2 cones, 20-meters apart. Participants will be instructed to walk at a constant speed for 2.5 minutes in each stage. Instructions will be to walk at their "slow" speed in stage 1, their "usual, comfortable" speed in stage 2, and their "brisk" speed in stage 3. | Procedure or surgery | Controls, Unilateral Transtibial Amputation |
Primary outcome
Change in gait speed pre- and post-walking tests
Time frame: immediately before/after
self-selected and fast speeds obtained with GaitRite
1 secondary outcome
Change in gait symmetry
Time frame: immediately before/after
Results and safety
The study was stopped early (reason given: Equipment used for metabolic testing is no longer serviced and/or supported by the company. Alternative equipment is not available to the research team to continue to conduct the study.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Mar 2022.
- Background: PubMed 25075192Swaminathan A, Vemulapalli S, Patel MR, Jones WS. Lower extremity amputation in peripheral artery disease: improving patient outcomes. Vasc Health Risk Manag. 2014 Jul 16;10:417-24. doi: 10.2147/VHRM.S50588. eCollection 2014.
- Background: PubMed 28033521Schuch F, Vancampfort D, Firth J, Rosenbaum S, Ward P, Reichert T, Bagatini NC, Bgeginski R, Stubbs B. Physical activity and sedentary behavior in people with major depressive disorder: A systematic review and meta-analysis. J Affect Disord. 2017 Mar 1;210:139-150. doi: 10.1016/j.jad.2016.10.050. Epub 2016 Nov 29.
- Background: PubMed 28198998Shuval K, Leonard T, Drope J, Katz DL, Patel AV, Maitin-Shepard M, Amir O, Grinstein A. Physical activity counseling in primary care: Insights from public health and behavioral economics. CA Cancer J Clin. 2017 May 6;67(3):233-244. doi: 10.3322/caac.21394. Epub 2017 Feb 15.
- Background: PubMed 14715035Tudor-Locke C, Bassett DR Jr. How many steps/day are enough? Preliminary pedometer indices for public health. Sports Med. 2004;34(1):1-8. doi: 10.2165/00007256-200434010-00001.
- Background: PubMed 16635636Klute GK, Berge JS, Orendurff MS, Williams RM, Czerniecki JM. Prosthetic intervention effects on activity of lower-extremity amputees. Arch Phys Med Rehabil. 2006 May;87(5):717-22. doi: 10.1016/j.apmr.2006.02.007.
- Background: PubMed 23934872Halsne EG, Waddingham MG, Hafner BJ. Long-term activity in and among persons with transfemoral amputation. J Rehabil Res Dev. 2013;50(4):515-30. doi: 10.1682/jrrd.2012.04.0066.
- Background: PubMed 27052673Desveaux L, Goldstein RS, Mathur S, Hassan A, Devlin M, Pauley T, Brooks D. Physical Activity in Adults with Diabetes Following Prosthetic Rehabilitation. Can J Diabetes. 2016 Aug;40(4):336-41. doi: 10.1016/j.jcjd.2016.02.003. Epub 2016 Apr 1.
- Background: PubMed 27932873Thyregod M, Bodtger U. Coherence between self-reported and objectively measured physical activity in patients with chronic obstructive lung disease: a systematic review. Int J Chron Obstruct Pulmon Dis. 2016 Nov 25;11:2931-2938. doi: 10.2147/COPD.S116422. eCollection 2016.
- Background: PubMed 18990237Prince SA, Adamo KB, Hamel ME, Hardt J, Connor Gorber S, Tremblay M. A comparison of direct versus self-report measures for assessing physical activity in adults: a systematic review. Int J Behav Nutr Phys Act. 2008 Nov 6;5:56. doi: 10.1186/1479-5868-5-56.
- Background: PubMed 23364470Rowe DA, McMinn D, Peacock L, Buis AW, Sutherland R, Henderson E, Hewitt A. Cadence, energy expenditure, and gait symmetry during music-prompted and self-regulated walking in adults with unilateral transtibial amputation. J Phys Act Health. 2014 Feb;11(2):320-9. doi: 10.1123/jpah.2012-0056. Epub 2013 Jan 30.
- Background: PubMed 16485518Tudor-Locke C, Sisson SB, Collova T, Lee SM, Swan PD. Pedometer-determined step count guidelines for classifying walking intensity in a young ostensibly healthy population. Can J Appl Physiol. 2005 Dec;30(6):666-76. doi: 10.1139/h05-147.
- Background: PubMed 22462794Tudor-Locke C, Rowe DA. Using cadence to study free-living ambulatory behaviour. Sports Med. 2012 May 1;42(5):381-98. doi: 10.2165/11599170-000000000-00000.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jaclyn M Sions, PhD, PT, DPT principal investigator
University of Delaware
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Amputees, run by University of Delaware at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 4 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Equipment used for metabolic testing is no longer serviced and/or supported by the company. Alternative equipment is not available to the research team to continue to conduct the study.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in gait speed pre- and post-walking tests (time frame: immediately before/after). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03722797, which also lists 57 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Mar 2022.