Instrument template · Performance outcomeUpdated September 28, 2026

6-minute walk test eCRF that records the conditions, not just the distance

The distance walked in six minutes is only comparable if the test was done the same way. This template captures the result with everything that affects it: course length, rests, oxygen, walking aids, heart rate, saturation and exertion.

  • Performance outcome site form
  • Pre and post measurements
  • Protocol conditions recorded

Free sandbox · No credit card · 21 CFR Part 11 aligned

6-minute walk test · Week 24
Subject 002-0014 · 30 m corridorDraft

Total distance walked

386m

Number of rests or stops

1

Supplemental oxygen during test

NoYes

SpO₂ at end of test

91%

Dyspnoea at end (Borg CR10)

012345678910
Range checks catch unit and entry errors

At a glance

  • The 6MWT measures the distance a participant can walk in six minutes on a flat, hard surface, usually a 30-metre corridor, following a standard protocol such as the American Thoracic Society guideline.
  • It is a performance outcome used as an endpoint in pulmonary, cardiovascular, neuromuscular and rare disease trials.
  • Results depend heavily on conditions: course length, standardised encouragement, practice tests, oxygen and walking aids. Record them.
  • Collect before and after measurements: heart rate, oxygen saturation, dyspnoea and fatigue on the Borg scale.
  • Minimal important differences vary by condition; use values established in your population.

Standardisation

Why the conditions belong on the form

The six-minute walk looks simple, and that is its appeal: no equipment beyond a corridor, a stopwatch and a pulse oximeter. But small changes in how it is run shift the result by tens of metres. A shorter course means more turns and shorter distances. Encouragement that varies between assessors changes effort. A practice walk on the same day raises the second result. Supplemental oxygen or a walking aid obviously matters.

For those reasons the test protocol should be written in the study manual and the key conditions recorded on the eCRF every time: course length, whether a practice test was done, oxygen flow if used, walking aid, and the number and duration of rests. When results look odd, these fields are what data managers and monitors check first.

Rests and early termination

Participants may slow down or stop and rest; the clock keeps running. Record the number of rests and, if the test is stopped early, the reason and the time. An early stop for chest pain or desaturation may also need to be recorded as an adverse event.

PRO

Patient-reported

Participant, own phone

ObsRO

Observer-reported

Caregiver

ClinRO

Clinician-reported

Site staff, clinic tablet

PerfO

Performance outcome

Site-run test, e.g. chair rise

Structure

Fields in the 6MWT template

FieldTypeNotes
Course lengthNumber (m)Usually 30 m; record every time.
Practice test performedSingle choiceSome protocols require one.
Walking aidDropdownNone, cane, walker, other.
Supplemental oxygen and flowSingle choice, number (L/min)Must match between visits.
Heart rate, SpO₂ before and afterNumberRange checks.
Borg dyspnoea and fatigue, before and afterLinear scale 0 to 10CR10 version.
Total distanceNumber (m)Range check; the endpoint.
Rests, early stop and reasonNumber, single choice, textReason prompts AE review when relevant.

In Capture

A site form completed by the assessor

Performance tests are completed by site staff during the visit and recorded as site forms. Every value is attributed to the assessor, range checks catch implausible distances or saturation values at entry, and SDV can focus on the distance and the conditions that affect it.

  • PerfO recorded as a site form.
  • Range checks with auto-queries.
  • Assessor attribution in the audit trail.
eCOA software (PRO, ClinRO, ObsRO, PerfO)
Vital signs · Systolic blood pressure

Edit checks / auto-queries

2
Auto-query

Type

Range High

Operator

Greater than

Value

180

Priority: High

Auto-query

Type

Range Low

Operator

Less than

Value

80

Priority: Normal

Query raised automatically

Value 192 violates limit (180). Please verify.

Add the 6MWT to a study visit

Copy the template, set your course length and test it with sample values.

Use the 6MWT template free

As an endpoint

Using the 6MWT as a trial endpoint

Six-minute walk distance is a primary or key secondary endpoint in pulmonary arterial hypertension, some neuromuscular and rare disease trials, and heart failure studies. Its main weakness is variability: participants walk further on a second attempt on the same day, and encouragement changes effort. Many protocols therefore include a practice walk at screening, use a standard encouragement script at fixed intervals, and train assessors across sites.

Safety rules belong in the protocol too: when to stop the test early (for example chest pain, severe breathlessness or low oxygen saturation), and what to record. An early stop recorded with its reason and time keeps the distance interpretable and flags possible adverse events.

Before go-live

6MWT setup checklist

Test manual written

Course, encouragement script, timing and stopping rules.

Practice walk decided

Whether one is done, and when.

Assessors trained

Same procedure at every site.

Range checks set

Distance, heart rate and SpO₂.

Oxygen and aids consistent

Same conditions at every visit for a participant.

Early stops captured

Reason and time, with AE review where relevant.

FAQ

Questions about this template

Something not covered here? Ask us directly.

What is the 6-minute walk test?

A performance test measuring how far a person can walk on a flat surface in six minutes, following a standard protocol.

What should a 6MWT CRF record?

Distance, course length, rests, oxygen use, walking aid, and heart rate, SpO₂ and Borg scores before and after the test.

Why record course length?

Shorter courses mean more turns and shorter distances, so results are only comparable on the same course.

Who completes the form?

The site staff member who runs the test. It is a performance outcome recorded as a site form.

Is the template free?

Yes, in the free sandbox.

Walk tests you can compare

Record the conditions with the distance. Free sandbox.

Use the 6MWT template free