Telehealth Exercise Training in Peripheral Arterial Disease - TEXT-PAD

NCT05260567 | Completed

• 1 other identifier: 286735
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

Peripheral arterial disease is a common, under-treated and under-researched issue. The vast majority of these patients often have multiple issues which can be improved with targeted behavioural change interventions. NICE has recommended that supervised exercise is the mainstay of treatment for intermittent claudication (ischaemic muscle pain on walking due to blocked and narrowed arteries). However, in the vast majority of UK hospitals, this isn't undertaken, and with the issues around group-based sessions and repeated visits to hospitals, this treatment option is not available with the coronavirus pandemic. This is a single-centre randomised control trial in 60 patients with peripheral arterial disease attending the Freeman Hospital. Patients will be randomised to either an enhanced behavioural change intervention targeting multiple health behaviours vs a simple walking intervention. Also, some patients will be involved in focus groups to understand their experience of the intervention and whether it is feasible and acceptable, allowing changes to be made to the program. The primary outcome will be to assess the feasibility and acceptability of the program. We will also be assessing multiple secondary outcomes including functional capacity, quality of life, sleep quality and smoking and alcohol reduction.

Conditions

Peripheral Arterial Disease; Intermittent Claudication; Behavior, Health; Exercise Intervention

Outcome Measures

Primary Outcomes (2)

• Feasibility of the program

  Feasibility will be determined by calculating the rate of patient screening, eligibility, recruitment, retention at 12 weeks and adherence to the intervention (number of sessions attended and completed)

  post 12 weeks

• Acceptability of the program

  Patient acceptability of the intervention and study experience more broadly will be determined through semi-structured qualitative 1-2-1 interviews and/or focus groups.

  post 12 weeks

Secondary Outcomes (12)

• Six-minute walk test (6MWT)

  pre and post-12 weeks

• Walking Impairment Questionnaire (WIQ)

  pre and post-12 weeks

• Walking Estimated Limitation Calculated by History (WELCH) questionnaire

  pre and post-12 weeks

• Vascular quality of life questionnaire (VascuQoL-6)

  pre and post-12 weeks

• EuroQoL questionnaire (EQ-5D-5L).

  pre and post-12 weeks

Study Arms (2)

Exercise and Lifestyle Change

EXPERIMENTAL

Exercise training and lifestyle change

Behavioral: Exercise and Lifestyle Change

Standard Care

OTHER

Patients will also receive specific advice to perform an unsupervised walking exercise according to NICE guideline.

Behavioral: Exercise and Lifestyle Change

Interventions

Exercise and Lifestyle Change BEHAVIORAL

Patients will undergo to weekly phone call/videoconference for 12 weeks and discuss the behaviour change. They also will undergo to home-based exercise training will be performed twice a week for 12 weeks via Zoom (up to 5 patients per session). Each session will be comprised of warm-up (10 min), the main part (15 to 20 min), and cooldown (5 to 10 min). The training aims to develop resistance, aerobic and functional capacity such as getting up, walking, pulling, pushing, throwing, transferring body weight or external loads. In addition, patients will be encouraged to increase their physical activity. Patients will be provided with a Fitbit device to monitor their step count and will be recommended to increase their previous week's average step count by 10%.

Exercise and Lifestyle Change; Standard Care

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Diagnosis of PAD confirmed by ankle-brachial index \<0.90 in one or both limbs
• Age \>= 40 years
• Able to walk distance \>50m
• Live in an area deemed in lowest 30% of super output area from Office of National Statistics

You may not qualify if:

• chronic limb threatening ischemia
• short claudication distance \<50m
• severe heart disease (Grade III or IV, New York Heart Association)
• severe ischemic or haemorrhagic stroke or neurodegenerative diseases
• severe hypertension (systolic blood pressure of more than 180 mm Hg, and a diastolic
• blood pressure of more than 100 mm Hg)
• uncontrolled cardiac arrhythmias (unstable angina during the previous month and
• myocardial infarction during the previous month)
• a resting heart rate of more than 120 beats per minute
• has already undergone angioplasty, bypass or other surgical intervention for PAD
• other severe comorbid conditions preventing the ability to engage in physical activity,
• inability or unwillingness to undertake the commitments of the study

Sponsors & Collaborators

• Northumbria University: lead

Study Sites (1)

Freeman Hospital - Newcastle upon Tyne NHS trust

Newcastle upon Tyne, United Kingdom

Location

MeSH Terms

Conditions

Peripheral Arterial Disease; Intermittent Claudication; Health Behavior

Interventions

Exercise

Condition Hierarchy (Ancestors)

Atherosclerosis; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Cardiovascular Diseases; Peripheral Vascular Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Behavior

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• James Prentis

  Freeman Hospital - Newcastle upon Tyne NHS trust

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Vice Chancellor Research Fellow

Study Record Dates

• First Submitted: February 15, 2022
• First Posted: March 2, 2022
• Study Start: February 5, 2022
• Primary Completion: July 30, 2023
• Study Completion: November 8, 2023
• Last Updated: November 13, 2023

Record last verified: 2023-11

Locations

GB (1)