Effectiveness of supervised exercise, home-based exercise, or walk advice strategies on walking performance and muscle endurance in patients with intermittent claudication (SUNFIT trial): a randomized clinical trial

Sandberg, Anna; Bäck, Maria; Cider, Åsa; Jivegård, Lennart; Sigvant, Birgitta; Wittboldt, Susanna; Nordanstig, Joakim

doi:10.1093/eurjcn/zvac070

Effectiveness of supervised exercise, home-based exercise, or walk advice strategies on walking performance and muscle endurance in patients with intermittent claudication (SUNFIT trial): a randomized clinical trial

Journal Article · Tue Aug 02 00:00:00 EDT 2022 · European Journal of Cardiovascular Nursing

DOI:https://doi.org/10.1093/eurjcn/zvac070· OSTI ID:1975161

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Abstract Aims

Supervised exercise is a guideline-recommended treatment in intermittent claudication (IC). Hospital-based supervised exercise programmes (SEPs) are underutilized, while home-based structured exercise programmes (HSEPs) have attracted interest. The results from HSEP in IC are inconsistent and may confer no benefit over walk advice (WA) and be less effective than SEP. The aim of the study was to compare the effectiveness of best medical treatment, including Nordic pole WA alone, or WA + SEP or WA + HSEP for patients with IC.

Methods and results

This three-armed, multicentre randomized clinical trial enrolled patients with IC; all patients received best medical treatment including walking poles and the advice of regular Nordic pole walking (WA). For HSEP and SEP, additional exercise programmes were provided. The primarily investigated hypothesis was a non-inferiority analysis of SEP vs. HSEP regarding the 6-min walk test (6MWT) maximum distance, with a pre-defined non-inferiority margin of 50 m. Supporting outcomes included muscle endurance tests and the walking impairment questionnaire. Outcomes were assessed at baseline, 3, 6, and 12 months by a blinded evaluator. Altogether 166 patients (mean age 72 years; 59% males) were randomized. In HSEP and SEP, 24 and 26% patients, respectively, were fully exercise adherent. All three groups improved pain-free walking distance over time, but there were no significant intergroup differences. The intergroup 6MWT difference between SEP and HSEP from 0 to 12 months was –11.6 m, 95% confidence interval: –36.4 to 13.0 m (i.e. within the pre-specified non-inferiority margin).

Conclusion

The HSEP was non-inferior to SEP in patients with IC. There were no significant differences observed between the three groups at 1 year.

Registration

ClinicialTrials.gov: NCT02341716.

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Sponsoring Organization:: USDOE Office of Electricity (OE), Advanced Grid Research & Development. Power Systems Engineering Research

OSTI ID:: 1975161

Journal Information:: European Journal of Cardiovascular Nursing, Journal Name: European Journal of Cardiovascular Nursing Journal Issue: 4 Vol. 22; ISSN 1474-5151

Publisher:: Oxford University PressCopyright Statement

Country of Publication:: Country unknown/Code not available

Language:: English

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Effectiveness of supervised exercise, home-based exercise, or walk advice strategies on walking performance and muscle endurance in patients with intermittent claudication (SUNFIT trial): a randomized clinical trial

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