Effect of Encouragement on Six Minute Walk Test Performance

NCT04586725 | Unknown

• 1 other identifier: UCentalLancashire2
• Study Type: interventional
• Target: 76
• Locations: 0 countries
• Sites: N/A

Brief Summary

Peripheral artery disease (PAD) is characterised by a build up of fatty plaque in the arteries in the lower limbs, resulting in a reduction of blow flow to the muscles. Globally, it is estimated that 236 million people are living with PAD. A classic symptom of PAD is intermittent claudication (IC) which is characterised by muscle cramps in the lower limbs, typically brought on by exercise and relieved at rest. Exercise is recommended at first line treatment for IC. However to assess IC symptoms in response to an exercise study, maximal walking capacity (the furthest they can walk before it becomes too painful to walk) is typically the main measure. A patients walking capacity is assessed by a number of exercise testing protocols including the six-minute walk test (6MWT), where patients walk for six minutes with the aim to walk as far as they can in the time allotted. Patient encouragement has been shown to improve walking performance by as much as 30 meters in heart failure and respiratory disease populations. However the effect of encouragement on walking performance in people with IC is yet to be studied.

Conditions

Intermittent Claudication

Outcome Measures

Primary Outcomes (1)

• Maximal walking distance (MWD)

  Metres walked during the tests

  6 weeks

Secondary Outcomes (1)

• Learning effect metres walked

  6 weeks

Study Arms (2)

Encouragement every minute

ACTIVE COMPARATOR

Patients will be randomised to six tests at one week apart

Other: Encouragement a one minute intervals; Other: Encouragement a two minute intervals

Encouragement every two minutes

ACTIVE COMPARATOR

Patients will be randomised to six tests at one week apart

Other: Encouragement a one minute intervals; Other: Encouragement a two minute intervals

Interventions

Encouragement a one minute intervals OTHER

Patients will perform the six exercise tests with encouragement at one minute intervals

Encouragement every minute; Encouragement every two minutes

Encouragement a two minute intervals OTHER

Patients will perform the six exercise tests with encouragement at two minute intervals

Encouragement every minute; Encouragement every two minutes

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \>18 years old
• Resting ankle brachial pressure index (ABPI) \<0.9 or a reduction of ≥ 20 mmHg following exercise testing (per site protocol)
• Able to walk unaided
• English speaking and able to follow exercise instructions
• Able to provide informed consent

You may not qualify if:

• Those who have critical limb threatening ischaemia (rest pain and/or tissue loss)
• Unable to provide consent
• Those presenting with any significant comorbidities or contraindications to exercise testing or training in accordance to the American College of Sports Medicine
• Uncontrolled or symptom limiting coronary heart or pulmonary disease

Sponsors & Collaborators

• University of Central Lancashire: lead
• Coventry University: collaborator
• University of Hull: collaborator
• University of Salford: collaborator

MeSH Terms

Conditions

Intermittent Claudication

Condition Hierarchy (Ancestors)

Peripheral Arterial Disease; Peripheral Vascular Diseases; Vascular Diseases; Cardiovascular Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Stefan Birkett, PhD

CONTACT

01772 893325; SBirkett4@uclan.ac.uk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Participants will be blinded to the level of encouragement they will receive during the tests
• Purpose: TREATMENT
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer In Exercise Science

Study Record Dates

• First Submitted: October 7, 2020
• First Posted: October 14, 2020
• Study Start: October 1, 2021
• Primary Completion: December 1, 2023
• Study Completion: January 1, 2024
• Last Updated: August 4, 2021

Record last verified: 2021-07

Data Sharing

• IPD Sharing: Will not share