Randomized controlled trial of vacuum therapy for intermittent claudication

David Hageman; Hugo J P Fokkenrood; Brit A C van Deursen; Lindy N M Gommans; Ernst Cancrinus; Marc R M Scheltinga; Joep A W Teijink

doi:10.1016/j.jvs.2019.08.239

Randomized controlled trial of vacuum therapy for intermittent claudication

David Hageman, Hugo J P Fokkenrood, Brit A C van Deursen, Lindy N M Gommans, Ernst Cancrinus, Marc R M Scheltinga, Joep A W Teijink^*

^*Corresponding author for this work

Research output: Contribution to journal › Article › Academic › peer-review

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Abstract

OBJECTIVE: The "gold standard" treatment of intermittent claudication (IC) is supervised exercise therapy (SET). Intermittent vacuum therapy (IVT) has recently been promoted as an additional treatment of IC. During IVT, negative pressure and atmospheric pressure are alternatingly applied to the lower extremities, possibly resulting in improved circulation. The aim of this study was to determine a potential additional effect of IVT in IC patients undergoing a standardized SET program.

METHODS: IC patients were recruited from three Dutch general hospitals between December 2015 and July 2017. They received a standardized SET program but were also randomly assigned to an intervention group receiving an IVT treatment (-50 mBar negative pressure) or a control group receiving a sham treatment (-5 mBar negative pressure). IVT was provided in a dedicated clinic during 12 sessions of 30 minutes during a 6-week period. The primary outcome measure was a change in maximal treadmill walking distance. Secondary outcome measures were a change in functional treadmill walking distance, 6-minute walk test, ambulatory ability, and quality of life.

RESULTS: A total of 78 patients were randomized, of whom 70 were available for intention-to-treat analysis (control, n = 34; intervention, n = 36). At 6 and 12 weeks, increases in walking distance were of equal magnitude. Median (interquartile range) change in maximal treadmill walking distance during 12 weeks was +335 (205-756) meters in control patients and +250 (77-466) meters in intervention patients (P = .109), whereas functional treadmill walking distance increased +230 (135-480) meters and +188 (83-389) meters (P = .233), respectively. Mean ± standard deviation change in the 6-minute walk test was +36 ± 48 meters and +55 ± 63 meters (P = .823), respectively. Ambulatory ability and quality of life improved equally in both groups.

CONCLUSIONS: IVT does not confer any additional beneficial effects in IC patients undergoing a standardized SET program.

Original language	English
Pages (from-to)	1692-1701.e1
Number of pages	11
Journal	Journal of Vascular Surgery
Volume	71
Issue number	5
DOIs	https://doi.org/10.1016/j.jvs.2019.08.239
Publication status	Published - May 2020

Keywords

Peripheral artery disease
Intermittent claudication
Supervised exercise therapy
Vacuum therapy
Negative pressure therapy
Randomized controlled trial
ARTERIAL OCCLUSIVE DISEASE
DUTCH VERSION
VASCUQOL QUESTIONNAIRE
NEGATIVE-PRESSURE
BLOOD-FLOW
RELIABILITY
VALIDATION
GUIDELINES
6-MINUTE
SOCIETY

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Cite this

@article{e72f551cb5e14999821808a6dae92467,

title = "Randomized controlled trial of vacuum therapy for intermittent claudication",

abstract = "OBJECTIVE: The {"}gold standard{"} treatment of intermittent claudication (IC) is supervised exercise therapy (SET). Intermittent vacuum therapy (IVT) has recently been promoted as an additional treatment of IC. During IVT, negative pressure and atmospheric pressure are alternatingly applied to the lower extremities, possibly resulting in improved circulation. The aim of this study was to determine a potential additional effect of IVT in IC patients undergoing a standardized SET program.METHODS: IC patients were recruited from three Dutch general hospitals between December 2015 and July 2017. They received a standardized SET program but were also randomly assigned to an intervention group receiving an IVT treatment (-50 mBar negative pressure) or a control group receiving a sham treatment (-5 mBar negative pressure). IVT was provided in a dedicated clinic during 12 sessions of 30 minutes during a 6-week period. The primary outcome measure was a change in maximal treadmill walking distance. Secondary outcome measures were a change in functional treadmill walking distance, 6-minute walk test, ambulatory ability, and quality of life.RESULTS: A total of 78 patients were randomized, of whom 70 were available for intention-to-treat analysis (control, n = 34; intervention, n = 36). At 6 and 12 weeks, increases in walking distance were of equal magnitude. Median (interquartile range) change in maximal treadmill walking distance during 12 weeks was +335 (205-756) meters in control patients and +250 (77-466) meters in intervention patients (P = .109), whereas functional treadmill walking distance increased +230 (135-480) meters and +188 (83-389) meters (P = .233), respectively. Mean ± standard deviation change in the 6-minute walk test was +36 ± 48 meters and +55 ± 63 meters (P = .823), respectively. Ambulatory ability and quality of life improved equally in both groups.CONCLUSIONS: IVT does not confer any additional beneficial effects in IC patients undergoing a standardized SET program.",

keywords = "Peripheral artery disease, Intermittent claudication, Supervised exercise therapy, Vacuum therapy, Negative pressure therapy, Randomized controlled trial, ARTERIAL OCCLUSIVE DISEASE, DUTCH VERSION, VASCUQOL QUESTIONNAIRE, NEGATIVE-PRESSURE, BLOOD-FLOW, RELIABILITY, VALIDATION, GUIDELINES, 6-MINUTE, SOCIETY",

author = "David Hageman and Fokkenrood, {Hugo J P} and {van Deursen}, {Brit A C} and Gommans, {Lindy N M} and Ernst Cancrinus and Scheltinga, {Marc R M} and Teijink, {Joep A W}",

year = "2020",

month = may,

doi = "10.1016/j.jvs.2019.08.239",

language = "English",

volume = "71",

pages = "1692--1701.e1",

journal = "Journal of Vascular Surgery",

issn = "0741-5214",

publisher = "MOSBY-ELSEVIER",

number = "5",

}

TY - JOUR

T1 - Randomized controlled trial of vacuum therapy for intermittent claudication

AU - Hageman, David

AU - Fokkenrood, Hugo J P

AU - van Deursen, Brit A C

AU - Gommans, Lindy N M

AU - Cancrinus, Ernst

AU - Scheltinga, Marc R M

AU - Teijink, Joep A W

PY - 2020/5

Y1 - 2020/5

N2 - OBJECTIVE: The "gold standard" treatment of intermittent claudication (IC) is supervised exercise therapy (SET). Intermittent vacuum therapy (IVT) has recently been promoted as an additional treatment of IC. During IVT, negative pressure and atmospheric pressure are alternatingly applied to the lower extremities, possibly resulting in improved circulation. The aim of this study was to determine a potential additional effect of IVT in IC patients undergoing a standardized SET program.METHODS: IC patients were recruited from three Dutch general hospitals between December 2015 and July 2017. They received a standardized SET program but were also randomly assigned to an intervention group receiving an IVT treatment (-50 mBar negative pressure) or a control group receiving a sham treatment (-5 mBar negative pressure). IVT was provided in a dedicated clinic during 12 sessions of 30 minutes during a 6-week period. The primary outcome measure was a change in maximal treadmill walking distance. Secondary outcome measures were a change in functional treadmill walking distance, 6-minute walk test, ambulatory ability, and quality of life.RESULTS: A total of 78 patients were randomized, of whom 70 were available for intention-to-treat analysis (control, n = 34; intervention, n = 36). At 6 and 12 weeks, increases in walking distance were of equal magnitude. Median (interquartile range) change in maximal treadmill walking distance during 12 weeks was +335 (205-756) meters in control patients and +250 (77-466) meters in intervention patients (P = .109), whereas functional treadmill walking distance increased +230 (135-480) meters and +188 (83-389) meters (P = .233), respectively. Mean ± standard deviation change in the 6-minute walk test was +36 ± 48 meters and +55 ± 63 meters (P = .823), respectively. Ambulatory ability and quality of life improved equally in both groups.CONCLUSIONS: IVT does not confer any additional beneficial effects in IC patients undergoing a standardized SET program.

AB - OBJECTIVE: The "gold standard" treatment of intermittent claudication (IC) is supervised exercise therapy (SET). Intermittent vacuum therapy (IVT) has recently been promoted as an additional treatment of IC. During IVT, negative pressure and atmospheric pressure are alternatingly applied to the lower extremities, possibly resulting in improved circulation. The aim of this study was to determine a potential additional effect of IVT in IC patients undergoing a standardized SET program.METHODS: IC patients were recruited from three Dutch general hospitals between December 2015 and July 2017. They received a standardized SET program but were also randomly assigned to an intervention group receiving an IVT treatment (-50 mBar negative pressure) or a control group receiving a sham treatment (-5 mBar negative pressure). IVT was provided in a dedicated clinic during 12 sessions of 30 minutes during a 6-week period. The primary outcome measure was a change in maximal treadmill walking distance. Secondary outcome measures were a change in functional treadmill walking distance, 6-minute walk test, ambulatory ability, and quality of life.RESULTS: A total of 78 patients were randomized, of whom 70 were available for intention-to-treat analysis (control, n = 34; intervention, n = 36). At 6 and 12 weeks, increases in walking distance were of equal magnitude. Median (interquartile range) change in maximal treadmill walking distance during 12 weeks was +335 (205-756) meters in control patients and +250 (77-466) meters in intervention patients (P = .109), whereas functional treadmill walking distance increased +230 (135-480) meters and +188 (83-389) meters (P = .233), respectively. Mean ± standard deviation change in the 6-minute walk test was +36 ± 48 meters and +55 ± 63 meters (P = .823), respectively. Ambulatory ability and quality of life improved equally in both groups.CONCLUSIONS: IVT does not confer any additional beneficial effects in IC patients undergoing a standardized SET program.

KW - Peripheral artery disease

KW - Intermittent claudication

KW - Supervised exercise therapy

KW - Vacuum therapy

KW - Negative pressure therapy

KW - Randomized controlled trial

KW - ARTERIAL OCCLUSIVE DISEASE

KW - DUTCH VERSION

KW - VASCUQOL QUESTIONNAIRE

KW - NEGATIVE-PRESSURE

KW - BLOOD-FLOW

KW - RELIABILITY

KW - VALIDATION

KW - GUIDELINES

KW - 6-MINUTE

KW - SOCIETY

U2 - 10.1016/j.jvs.2019.08.239

DO - 10.1016/j.jvs.2019.08.239

M3 - Article

C2 - 31690523

VL - 71

SP - 1692-1701.e1

JO - Journal of Vascular Surgery

JF - Journal of Vascular Surgery

SN - 0741-5214

IS - 5

ER -