Effect of a home-based exercise intervention of wearable technology and telephone coaching on walking performance in peripheral artery disease

The honor randomized clinical trial

Mary McGrae McDermott*, Bonnie Spring, Jeffrey S. Berger, Diane Treat-Jacobson, Michael S. Conte, Mark A. Creager, Michael H. Criqui, Luigi Ferrucci, Heather L. Gornik, Jack M. Guralnik, Elizabeth A Hahn, Peter Henke, Melina R. Kibbe, Debra Kohlman-Trighoff, Lingyu Li, Donald M Lloyd-Jones, Walter McCarthy, Tamar S. Polonsky, Christopher Skelly, Lu Tian & 3 others Lihui Zhao, Dongxue Zhang, W. Jack Rejeski

*Corresponding author for this work

Research output: Contribution to journalArticle

20 Citations (Scopus)

Abstract

IMPORTANCE: Clinical practice guidelines support home-based exercise for patients with peripheral artery disease (PAD), but no randomized trials have tested whether an exercise intervention without periodic medical center visits improves walking performance. OBJECTIVE: To determine whether a home-based exercise intervention consisting of a wearable activity monitor and telephone coaching improves walking ability over 9 months inpatients with PAD. DESIGN, SETTING, AND PARTICIPANTS: Randomized clinical trial conducted at 3 US medical centers. Patients with PAD were randomized between June 18, 2015, and April 4, 2017, to home-based exercise vs usual care for 9 months. Final follow-up was on December 5, 2017. INTERVENTIONS: The exercise intervention group (n = 99) received 4 weekly medical center visits during the first month followed by 8 months of a wearable activity monitor and telephone coaching. The usual care group (n = 101) received no onsite sessions, active exercise, or coaching intervention. MAIN OUTCOMES AND MEASURES: The primary outcome was change in 6-minute walk distance at 9-month follow-up (minimal clinically important difference [MCID], 20 m). Secondary outcomes included 9-month change in subcomponents of the Walking Impairment Questionnaire (WIQ) (0-100 score; 100, best), SF-36 physical functioning score, Patient-Reported Outcomes Measurement Information System (PROMIS) mobility questionnaire (higher = better; MCID, 2 points), PROMIS satisfaction with social roles questionnaire, PROMIS pain interference questionnaire (lower = better; MCID range, 3.5-4.5 points), and objectively measured physical activity. RESULTS: Among200 randomized participants (mean [SD] age, 70.2 [10.4] years; 105 [52.5%] women), 182 (91%) completed 9-month follow-up. The mean change from baseline to 9-month follow-up in the 6-minute walk distance was 5.5 m in the intervention group vs 14.4 m in the usual care group (difference, -8.9 m; 95% CI, -26.0 to 8.2 m; P =.31). The exercise intervention worsened the PROMIS pain interference score, mean change from baseline to 9 months was 0.7 in the intervention group vs -2.8 in the usual care group (difference, 3.5; 95% CI, 1.3 to 5.8; P =.002). There were no significant between-group differences in the WIQ score, the SF-36 physical functioning score, or the PROMIS mobility or satisfaction with social roles scores. CONCLUSIONS AND RELEVANCE: Among patients with PAD, a home-based exercise intervention consisting of a wearable activity monitor and telephone coaching, compared with usual care, did not improve walking performance at 9-month follow-up. These results do not support home-based exercise interventions of wearable devices and telephone counseling without periodic onsite visits to improve walking performance in patients with PAD.

Original languageEnglish (US)
Pages (from-to)1665-1676
Number of pages12
JournalJAMA - Journal of the American Medical Association
Volume319
Issue number16
DOIs
StatePublished - Apr 24 2018

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Peripheral Arterial Disease
Telephone
Walking
Randomized Controlled Trials
Exercise
Technology
Information Systems
Mentoring
Pain
Aptitude
Practice Guidelines
Counseling
Inpatients
Surveys and Questionnaires
Patient Reported Outcome Measures
Equipment and Supplies

ASJC Scopus subject areas

  • Medicine(all)

Cite this

McDermott, Mary McGrae ; Spring, Bonnie ; Berger, Jeffrey S. ; Treat-Jacobson, Diane ; Conte, Michael S. ; Creager, Mark A. ; Criqui, Michael H. ; Ferrucci, Luigi ; Gornik, Heather L. ; Guralnik, Jack M. ; Hahn, Elizabeth A ; Henke, Peter ; Kibbe, Melina R. ; Kohlman-Trighoff, Debra ; Li, Lingyu ; Lloyd-Jones, Donald M ; McCarthy, Walter ; Polonsky, Tamar S. ; Skelly, Christopher ; Tian, Lu ; Zhao, Lihui ; Zhang, Dongxue ; Rejeski, W. Jack. / Effect of a home-based exercise intervention of wearable technology and telephone coaching on walking performance in peripheral artery disease : The honor randomized clinical trial. In: JAMA - Journal of the American Medical Association. 2018 ; Vol. 319, No. 16. pp. 1665-1676.
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title = "Effect of a home-based exercise intervention of wearable technology and telephone coaching on walking performance in peripheral artery disease: The honor randomized clinical trial",
abstract = "IMPORTANCE: Clinical practice guidelines support home-based exercise for patients with peripheral artery disease (PAD), but no randomized trials have tested whether an exercise intervention without periodic medical center visits improves walking performance. OBJECTIVE: To determine whether a home-based exercise intervention consisting of a wearable activity monitor and telephone coaching improves walking ability over 9 months inpatients with PAD. DESIGN, SETTING, AND PARTICIPANTS: Randomized clinical trial conducted at 3 US medical centers. Patients with PAD were randomized between June 18, 2015, and April 4, 2017, to home-based exercise vs usual care for 9 months. Final follow-up was on December 5, 2017. INTERVENTIONS: The exercise intervention group (n = 99) received 4 weekly medical center visits during the first month followed by 8 months of a wearable activity monitor and telephone coaching. The usual care group (n = 101) received no onsite sessions, active exercise, or coaching intervention. MAIN OUTCOMES AND MEASURES: The primary outcome was change in 6-minute walk distance at 9-month follow-up (minimal clinically important difference [MCID], 20 m). Secondary outcomes included 9-month change in subcomponents of the Walking Impairment Questionnaire (WIQ) (0-100 score; 100, best), SF-36 physical functioning score, Patient-Reported Outcomes Measurement Information System (PROMIS) mobility questionnaire (higher = better; MCID, 2 points), PROMIS satisfaction with social roles questionnaire, PROMIS pain interference questionnaire (lower = better; MCID range, 3.5-4.5 points), and objectively measured physical activity. RESULTS: Among200 randomized participants (mean [SD] age, 70.2 [10.4] years; 105 [52.5{\%}] women), 182 (91{\%}) completed 9-month follow-up. The mean change from baseline to 9-month follow-up in the 6-minute walk distance was 5.5 m in the intervention group vs 14.4 m in the usual care group (difference, -8.9 m; 95{\%} CI, -26.0 to 8.2 m; P =.31). The exercise intervention worsened the PROMIS pain interference score, mean change from baseline to 9 months was 0.7 in the intervention group vs -2.8 in the usual care group (difference, 3.5; 95{\%} CI, 1.3 to 5.8; P =.002). There were no significant between-group differences in the WIQ score, the SF-36 physical functioning score, or the PROMIS mobility or satisfaction with social roles scores. CONCLUSIONS AND RELEVANCE: Among patients with PAD, a home-based exercise intervention consisting of a wearable activity monitor and telephone coaching, compared with usual care, did not improve walking performance at 9-month follow-up. These results do not support home-based exercise interventions of wearable devices and telephone counseling without periodic onsite visits to improve walking performance in patients with PAD.",
author = "McDermott, {Mary McGrae} and Bonnie Spring and Berger, {Jeffrey S.} and Diane Treat-Jacobson and Conte, {Michael S.} and Creager, {Mark A.} and Criqui, {Michael H.} and Luigi Ferrucci and Gornik, {Heather L.} and Guralnik, {Jack M.} and Hahn, {Elizabeth A} and Peter Henke and Kibbe, {Melina R.} and Debra Kohlman-Trighoff and Lingyu Li and Lloyd-Jones, {Donald M} and Walter McCarthy and Polonsky, {Tamar S.} and Christopher Skelly and Lu Tian and Lihui Zhao and Dongxue Zhang and Rejeski, {W. Jack}",
year = "2018",
month = "4",
day = "24",
doi = "10.1001/jama.2018.3275",
language = "English (US)",
volume = "319",
pages = "1665--1676",
journal = "JAMA - Journal of the American Medical Association",
issn = "0098-7484",
publisher = "American Medical Association",
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}

McDermott, MM, Spring, B, Berger, JS, Treat-Jacobson, D, Conte, MS, Creager, MA, Criqui, MH, Ferrucci, L, Gornik, HL, Guralnik, JM, Hahn, EA, Henke, P, Kibbe, MR, Kohlman-Trighoff, D, Li, L, Lloyd-Jones, DM, McCarthy, W, Polonsky, TS, Skelly, C, Tian, L, Zhao, L, Zhang, D & Rejeski, WJ 2018, 'Effect of a home-based exercise intervention of wearable technology and telephone coaching on walking performance in peripheral artery disease: The honor randomized clinical trial', JAMA - Journal of the American Medical Association, vol. 319, no. 16, pp. 1665-1676. https://doi.org/10.1001/jama.2018.3275

Effect of a home-based exercise intervention of wearable technology and telephone coaching on walking performance in peripheral artery disease : The honor randomized clinical trial. / McDermott, Mary McGrae; Spring, Bonnie; Berger, Jeffrey S.; Treat-Jacobson, Diane; Conte, Michael S.; Creager, Mark A.; Criqui, Michael H.; Ferrucci, Luigi; Gornik, Heather L.; Guralnik, Jack M.; Hahn, Elizabeth A; Henke, Peter; Kibbe, Melina R.; Kohlman-Trighoff, Debra; Li, Lingyu; Lloyd-Jones, Donald M; McCarthy, Walter; Polonsky, Tamar S.; Skelly, Christopher; Tian, Lu; Zhao, Lihui; Zhang, Dongxue; Rejeski, W. Jack.

In: JAMA - Journal of the American Medical Association, Vol. 319, No. 16, 24.04.2018, p. 1665-1676.

Research output: Contribution to journalArticle

TY - JOUR

T1 - Effect of a home-based exercise intervention of wearable technology and telephone coaching on walking performance in peripheral artery disease

T2 - The honor randomized clinical trial

AU - McDermott, Mary McGrae

AU - Spring, Bonnie

AU - Berger, Jeffrey S.

AU - Treat-Jacobson, Diane

AU - Conte, Michael S.

AU - Creager, Mark A.

AU - Criqui, Michael H.

AU - Ferrucci, Luigi

AU - Gornik, Heather L.

AU - Guralnik, Jack M.

AU - Hahn, Elizabeth A

AU - Henke, Peter

AU - Kibbe, Melina R.

AU - Kohlman-Trighoff, Debra

AU - Li, Lingyu

AU - Lloyd-Jones, Donald M

AU - McCarthy, Walter

AU - Polonsky, Tamar S.

AU - Skelly, Christopher

AU - Tian, Lu

AU - Zhao, Lihui

AU - Zhang, Dongxue

AU - Rejeski, W. Jack

PY - 2018/4/24

Y1 - 2018/4/24

N2 - IMPORTANCE: Clinical practice guidelines support home-based exercise for patients with peripheral artery disease (PAD), but no randomized trials have tested whether an exercise intervention without periodic medical center visits improves walking performance. OBJECTIVE: To determine whether a home-based exercise intervention consisting of a wearable activity monitor and telephone coaching improves walking ability over 9 months inpatients with PAD. DESIGN, SETTING, AND PARTICIPANTS: Randomized clinical trial conducted at 3 US medical centers. Patients with PAD were randomized between June 18, 2015, and April 4, 2017, to home-based exercise vs usual care for 9 months. Final follow-up was on December 5, 2017. INTERVENTIONS: The exercise intervention group (n = 99) received 4 weekly medical center visits during the first month followed by 8 months of a wearable activity monitor and telephone coaching. The usual care group (n = 101) received no onsite sessions, active exercise, or coaching intervention. MAIN OUTCOMES AND MEASURES: The primary outcome was change in 6-minute walk distance at 9-month follow-up (minimal clinically important difference [MCID], 20 m). Secondary outcomes included 9-month change in subcomponents of the Walking Impairment Questionnaire (WIQ) (0-100 score; 100, best), SF-36 physical functioning score, Patient-Reported Outcomes Measurement Information System (PROMIS) mobility questionnaire (higher = better; MCID, 2 points), PROMIS satisfaction with social roles questionnaire, PROMIS pain interference questionnaire (lower = better; MCID range, 3.5-4.5 points), and objectively measured physical activity. RESULTS: Among200 randomized participants (mean [SD] age, 70.2 [10.4] years; 105 [52.5%] women), 182 (91%) completed 9-month follow-up. The mean change from baseline to 9-month follow-up in the 6-minute walk distance was 5.5 m in the intervention group vs 14.4 m in the usual care group (difference, -8.9 m; 95% CI, -26.0 to 8.2 m; P =.31). The exercise intervention worsened the PROMIS pain interference score, mean change from baseline to 9 months was 0.7 in the intervention group vs -2.8 in the usual care group (difference, 3.5; 95% CI, 1.3 to 5.8; P =.002). There were no significant between-group differences in the WIQ score, the SF-36 physical functioning score, or the PROMIS mobility or satisfaction with social roles scores. CONCLUSIONS AND RELEVANCE: Among patients with PAD, a home-based exercise intervention consisting of a wearable activity monitor and telephone coaching, compared with usual care, did not improve walking performance at 9-month follow-up. These results do not support home-based exercise interventions of wearable devices and telephone counseling without periodic onsite visits to improve walking performance in patients with PAD.

AB - IMPORTANCE: Clinical practice guidelines support home-based exercise for patients with peripheral artery disease (PAD), but no randomized trials have tested whether an exercise intervention without periodic medical center visits improves walking performance. OBJECTIVE: To determine whether a home-based exercise intervention consisting of a wearable activity monitor and telephone coaching improves walking ability over 9 months inpatients with PAD. DESIGN, SETTING, AND PARTICIPANTS: Randomized clinical trial conducted at 3 US medical centers. Patients with PAD were randomized between June 18, 2015, and April 4, 2017, to home-based exercise vs usual care for 9 months. Final follow-up was on December 5, 2017. INTERVENTIONS: The exercise intervention group (n = 99) received 4 weekly medical center visits during the first month followed by 8 months of a wearable activity monitor and telephone coaching. The usual care group (n = 101) received no onsite sessions, active exercise, or coaching intervention. MAIN OUTCOMES AND MEASURES: The primary outcome was change in 6-minute walk distance at 9-month follow-up (minimal clinically important difference [MCID], 20 m). Secondary outcomes included 9-month change in subcomponents of the Walking Impairment Questionnaire (WIQ) (0-100 score; 100, best), SF-36 physical functioning score, Patient-Reported Outcomes Measurement Information System (PROMIS) mobility questionnaire (higher = better; MCID, 2 points), PROMIS satisfaction with social roles questionnaire, PROMIS pain interference questionnaire (lower = better; MCID range, 3.5-4.5 points), and objectively measured physical activity. RESULTS: Among200 randomized participants (mean [SD] age, 70.2 [10.4] years; 105 [52.5%] women), 182 (91%) completed 9-month follow-up. The mean change from baseline to 9-month follow-up in the 6-minute walk distance was 5.5 m in the intervention group vs 14.4 m in the usual care group (difference, -8.9 m; 95% CI, -26.0 to 8.2 m; P =.31). The exercise intervention worsened the PROMIS pain interference score, mean change from baseline to 9 months was 0.7 in the intervention group vs -2.8 in the usual care group (difference, 3.5; 95% CI, 1.3 to 5.8; P =.002). There were no significant between-group differences in the WIQ score, the SF-36 physical functioning score, or the PROMIS mobility or satisfaction with social roles scores. CONCLUSIONS AND RELEVANCE: Among patients with PAD, a home-based exercise intervention consisting of a wearable activity monitor and telephone coaching, compared with usual care, did not improve walking performance at 9-month follow-up. These results do not support home-based exercise interventions of wearable devices and telephone counseling without periodic onsite visits to improve walking performance in patients with PAD.

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U2 - 10.1001/jama.2018.3275

DO - 10.1001/jama.2018.3275

M3 - Article

VL - 319

SP - 1665

EP - 1676

JO - JAMA - Journal of the American Medical Association

JF - JAMA - Journal of the American Medical Association

SN - 0098-7484

IS - 16

ER -