An interventional study of High-intensity interval training in Peripheral Arterial Disease and Intermittent Claudication, sponsored by Hull University Teaching Hospitals NHS Trust. Completed at 1 site in United Kingdom. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-11-14.
Sponsored by Hull University Teaching Hospitals NHS Trust · Not applicable, Interventional, and Treatment
This INITIATE study evaluates the use of high-intensity interval training as a treatment modality for patients with intermittent claudication - an ambulatory leg pain caused by narrowed arteries that supply the lower limbs.
It is an observational cohort study considering high-intensity interval training (HIIT) as a treatment for intermittent claudication, consisting of two workstreams. Workstream 1: an initial observational cohort study to consider the feasibility of the intervention and exclusion criteria. Workstream 2: a proof of concept study utilising the altered intervention and exclusion criteria following recommendations highlighted during workstream 1.
Patients with peripheral vascular disease (PVD) may develop a reproducible pain in their legs when they walk, which usually subsides with rest. This is known as intermittent claudication (IC) and is caused by a reduced blood supply to the legs as a result of narrowed or hardened arteries that supply the lower limbs. This ambulatory pain impedes on activities of daily living, functional capacity and quality of life.
National Institute for Health and Care Excellence (NICE) clinical guidance recommends a 12-week supervised exercise programme as first-line treatment for IC, whereby patients are encouraged to walk to the point of maximal pain. Robust clinical trials have demonstrated that supervised exercise programmes are efficacious for improving both pain-free and maximal walking distances, whilst also potentially improving quality of life.
Despite this, supervised exercise programmes are vastly under-utilised and not always available to consultant vascular surgeons. This means that further programmes need to be developed in order to provide a range of options to patients to improve uptake and adherence rates. One such programme is a 6-week high-intensity interval training programme.
An initial observational cohort study of the 6 week HIIT programme will be conducted to determine to determine the feasibility of the intervention and inclusion criteria. The results from this will be used to make any necessary changes to the HIIT intervention before moving into a proof of concept study, considering the utility, safety, acceptability and potential clinical efficacy of this programme.
1,542 studies on the registry are indexed under Peripheral Arterial Disease; 282 are open to participants now.
This study's enrollment of 70 is close to the median of 74 across 1,066 interventional studies indexed under Peripheral Arterial Disease.
Browse Peripheral Arterial Disease studies →Hull University Teaching Hospitals NHS Trust is the lead sponsor of 93 studies on the registry; 15 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Workstream 1
Inclusion criteria:
Exclusion criteria:
Additional exclusion criteria:
Following baseline cardiopulmonary exercise test (CPET), patients will be withdrawn and prevented from continuing their involvement in the study if there is any evidence of:
Workstream 2:
Inclusion criteria:
Exclusion criteria:
Additional exclusion criteria:
Following baseline CPET, patients will be withdrawn and prevented from continuing their involvement in the study if there is any evidence of:
● Exercise-induced myocardial ischaemia or significant haemodynamic compromise (manifesting as anginal symptoms, significant ECG changes or an abnormal blood pressure response).
High-intensity interval training performed for 20 minutes, 3 times weekly for a period of 6 weeks at 85-100% of maximal heart rate.
Other: High-intensity interval training
a high-intensity interval training programme completed 3 times a week for 6 weeks using a stationary Wattbike.
Tolerability Test - Related Withdrawals
Defined by examining the number of withdrawals related to the intervention or study procedures (i.e. patients unable to tolerate).
Time frame: From the first to last exercise session, i.e. from week 0 to week 6.
Feasibility Test
Feasibility measures included the number of patients screened vs. the number eligible, the number of patients eligible vs. the number recruited and the number recruited vs. the number completed.
Time frame: From study opening to completion/withdrawal of the last patient
Tolerability Test - Achieving the Required Intensity
Considers the patients ability to achieve and maintain exercise at the appropriate intensity for the duration of each session
Time frame: From the first to last exercise session, i.e. from week 0 to week 6.
Tolerability Test - Number of Sessions Completed
Considers the number of sessions completed compared to the theoretical number.
Time frame: From the first to last exercise session, i.e. from week 0 to week 6.
Tolerability Test - Number of HIIT Intervals Completed
Considers the number of HIIT intervals completed compared to the theoretical number.
Time frame: From the first to last exercise session, i.e. from week 0 to week 6.
Safety Events Recorded
Defined as the occurrence of any adverse or serious adverse events related to the intervention.
Time frame: From enrolment to completion of 12-week follow-up
Acceptability Testing
An evaluation of the acceptability of the exercise intervention assessed by patient feedback, using semi-structured interviews.
Time frame: post-intervention follow-up, i.e. week 6.
Maximum Walking Distance
assessment of the distance that the patient can currently walk before having to stop due to claudication pain.
Time frame: Baseline, post-intervention (week 6), then 4 weeks (week 10) and 12 weeks (week 18) post-intervention.
Peak Oxygen Uptake
Peak oxygen uptake assessed via cardiopulmonary exercise testing
Time frame: Baseline, post-intervention (week 6), then 4 weeks (week 10) and 12 weeks (week 18) post-intervention.
Quality of Life Questionnaire Short-form-36 (SF-36)
Patient reported quality of life using the SF-36 SF-36 is a 36-Item Short Form Health Survey questionnaire. It consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability. The higher the score the less disability.
Time frame: Baseline and post-intervention (week 6)
Vascular Quality of Life Questionnaire - (VascuQol)
VascuQoL includes 25 items subdivided into 5 domains and a sum score is also calculated by dividing the total score by 25. Each domain and the total score range from 1 to 7 with 1 representing the worst score and 7 the best.
Time frame: Baseline and post-intervention (week 6) follow-up
Ankle-Brachial Pressure Index
The index or ratio of the pressure in the ankle compared with the arm.
Time frame: Baseline, post-intervention (week 6), then 4 weeks (week 10) and 12 weeks (week 18) post-intervention.
Peak Power Output
Peak power output assessed via CPET
Time frame: Baseline, post-intervention (week 6), then 4 weeks (week 10) and 12 weeks (week 18) post-intervention.
Pain-free Walking Distance
assessment of the distance that the patient can currently walk before experiencing claudication pain.
Time frame: Baseline, post-intervention (week 6), then 4 weeks (week 10) and 12 weeks (week 18) post-intervention.
Ventilatory Anaerobic Threshold (VAT)
Ventilatory anaerobic threshold assessed via cardiopulmonary exercise testing
Time frame: Baseline, post-intervention (week 6), then 4 weeks (week 10) and 12 weeks (week 18) post-intervention.
Quality of Life Questionnaire Short-form-36 (SF-36)
Patient reported quality of life using the SF-36 SF-36 is a 36-Item Short Form Health Survey questionnaire. It consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability. The higher the score the less disability.
Time frame: 4 weeks (week 10) and 12 weeks (week 18) post-intervention
Vascular Quality of Life Questionnaire - (VascuQol)
VascuQoL includes 25 items subdivided into 5 domains and a sum score is also calculated by dividing the total score by 25. Each domain and the total score range from 1 to 7 with 1 representing the worst score and 7 the best.
Time frame: 4 weeks (week 10) and 12 weeks (week 18) post-intervention.
| Milestone | High-Intensity Interval Training |
|---|---|
| Started | 70 |
| Participants enrolled in workstream 1 | 30 |
| Participants completing workstream 1 | 15 |
| Participants enrolled in workstream 2 | 40 |
| Participants completing workstream 2 | 31 |
| Completed | 46 |
| Not completed | 24 |
| Withdrew: Abnormal cardiopulmonary exercise test (cpet) or unable to achieve a maximal test | 9 |
| Withdrew: Unable to tolerate | 4 |
| Withdrew: Concurrent illness | 2 |
| Withdrew: Adverse event | 2 |
| Withdrew: No longer meeting inclusion criteria | 2 |
| Withdrew: No reason given | 1 |
| Withdrew: Withdrawal by subject | 4 |
Defined by examining the number of withdrawals related to the intervention or study procedures (i.e. patients unable to tolerate).
| Participants | High-Intensity Interval Training |
|---|---|
| Workstream 1 - unable to tolerate HIIT or CPEX | 1 |
| Workstream 2 - unable to tolerate HIIT or CPEX | 3 |
Feasibility measures included the number of patients screened vs. the number eligible, the number of patients eligible vs. the number recruited and the number recruited vs. the number completed.
| participants | High-Intensity Interval Training |
|---|---|
| Workstream 1 - screened | 144 |
| Workstream 1 - eligible | 95 |
| Workstream 1 - recruited | 30 |
| Workstream 1 - completed | 15 |
| Workstream 2 - screened | 280 |
| Workstream 2 - eligible | 165 |
| Workstream 2 - recruited | 40 |
| Workstream 2 - completed | 31 |
Considers the patients ability to achieve and maintain exercise at the appropriate intensity for the duration of each session
| Number of HIIT intervals | High-Intensity Interval Training |
|---|---|
| Workstream 1 - intervals at the required intensity | 2210 |
| Workstream 2 - intervals at the required intensity | 4546 |
Considers the number of sessions completed compared to the theoretical number.
| Number of HIIT sessions | High-Intensity Interval Training |
|---|---|
| Workstream 1 - HIIT sessions completed | 270 |
| Workstream 2 - HIIT sessions completed | 551 |
Considers the number of HIIT intervals completed compared to the theoretical number.
| Number of HIIT intervals | High-Intensity Interval Training |
|---|---|
| Workstream 1 - HIIT intervals completed | 234 |
| Workstream 2 - HIIT intervals completed | 475 |
Defined as the occurrence of any adverse or serious adverse events related to the intervention.
| Events | High-Intensity Interval Training |
|---|---|
| Workstream 1 | 3 |
| Workstream 2 | 9 |
An evaluation of the acceptability of the exercise intervention assessed by patient feedback, using semi-structured interviews.
| Participants | High-Intensity Interval Training |
|---|---|
| Acceptability Testing | 23 |
assessment of the distance that the patient can currently walk before having to stop due to claudication pain.
| metres | High-Intensity Interval Training |
|---|---|
| Workstream 1 baseline | 243.8 ± 102.2 |
| Workstream 1 Post-intervention follow-up | 365.2 ± 153.6 |
| Workstream 1 - 4-week post intervention follow-up | 365.4 ± 172.3 |
| Workstream 1 - 12-week post intervention follow-up | 374.2 ± 233.4 |
| Workstream 2 baseline | 366.5 ± 201.0 |
| Workstream 2 Post-intervention follow-up | 455.0 ± 220.8 |
| Workstream 2 - 4-week post intervention follow-up | 450.7 ± 242.8 |
| Workstream 2 - 12-week post intervention follow-up | 448.1 ± 240.9 |
Peak oxygen uptake assessed via cardiopulmonary exercise testing
| ml/kg/min | High-Intensity Interval Training |
|---|---|
| Workstream 1 - baseline VO2Peak | 15.4 ± 2.8 |
| Workstream 1 - post-intervention follow-up VO2Peak | 15.9 ± 3.0 |
| Workstream 1 - 4-week post-intervention follow-up VO2Peak | 15.8 ± 2.3 |
| Workstream 1 - 12-week post-intervention follow-up VO2Peak | 15.3 ± 3.1 |
| Workstream 2 - baseline VO2Peak | 16.4 ± 3.9 |
| Workstream 2 - post-intervention follow-up VO2Peak | 17.1 ± 4.3 |
| Workstream 2 - 4-week post-intervention follow-up VO2Peak | 16.9 ± 4.6 |
| Workstream 2 - 12-week post-intervention follow-up VO2Peak | 17.8 ± 4.1 |
Patient reported quality of life using the SF-36 SF-36 is a 36-Item Short Form Health Survey questionnaire. It consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability. The higher the score the less disability.
| units on a scale | High-Intensity Interval Training |
|---|---|
| Workstream 1 baseline physical functioning | 50.1 ± 18.2 |
| Workstream 1 follow-up physical functioning | 54.7 ± 20.2 |
| Workstream 1 baseline role physical | 52.5 ± 26.9 |
| Workstream 1 follow-up role physical | 55.4 ± 27.7 |
| Workstream 1 baseline pain | 47.9 ± 13.9 |
| Workstream 1 follow-up pain | 50.0 ± 22.6 |
| Workstream 1 baseline general health | 46.6 ± 19.9 |
| Workstream 1 follow-up general health | 52.7 ± 20.8 |
| Workstream 1 baseline vitality | 41.5 ± 15.2 |
| Workstream 1 follow-up vitality | 50.9 ± 17.4 |
| Workstream 1 baseline social functioning | 76.8 ± 26.3 |
| Workstream 1 follow-up social functioning | 76.8 ± 27.2 |
| Workstream 1 baseline role emotional | 73.3 ± 30.2 |
| Workstream 1 follow-up role emotional | 80.0 ± 25.2 |
| Workstream 1 baseline mental health | 68.6 ± 17.7 |
| Workstream 1 follow-up mental health | 73.6 ± 17.8 |
| Workstream 1 baseline PCS | 37.8 ± 7.6 |
| Workstream 1 follow-up PCS | 39.4 ± 7.3 |
| Workstream 1 baseline MCS | 49.2 ± 9.9 |
| Workstream 1 follow-up MCS | 51.9 ± 9.4 |
| Workstream 2 baseline physical functioning | 53.3 ± 19.2 |
| Workstream 2 follow-up physical functioning | 56.2 ± 19.1 |
| Workstream 2 baseline role physical | 52.9 ± 23.9 |
| Workstream 2 follow-up role physical | 60.8 ± 24.7 |
| Workstream 2 baseline pain | 47.3 ± 19.9 |
| Workstream 2 follow-up pain | 54.1 ± 22.6 |
| Workstream 2 baseline general health | 54.4 ± 21.2 |
| Workstream 2 follow-up general health | 54.8 ± 19.3 |
| Workstream 2 baseline vitality | 53.2 ± 17.8 |
| Workstream 2 follow-up vitality | 55.8 ± 19.3 |
| Workstream 2 baseline social functioning | 77.5 ± 24.7 |
| Workstream 2 follow-up social functioning | 75.4 ± 27.9 |
| Workstream 2 baseline role emotional | 73.1 ± 25.2 |
| Workstream 2 follow-up role emotional | 75.6 ± 25.3 |
| Workstream 2 baseline mental health | 76.7 ± 14.5 |
| Workstream 2 follow-up mental health | 76.7 ± 19.8 |
| Workstream 2 baseline PCS | 38.5 ± 7.0 |
| Workstream 2 follow-up PCS | 40.7 ± 7.3 |
| Workstream 2 baseline MCS | 52.3 ± 8.8 |
| Workstream 2 follow-up MCS | 52 ± 10.4 |
VascuQoL includes 25 items subdivided into 5 domains and a sum score is also calculated by dividing the total score by 25. Each domain and the total score range from 1 to 7 with 1 representing the worst score and 7 the best.
| units on a scale | High-Intensity Interval Training |
|---|---|
| Workstream 1 baseline pain score | 4.2 ± 1.3 |
| Workstream 1 follow-up pain score | 4.4 ± 1.5 |
| Workstream 1 baseline social score | 5.5 ± 1.7 |
| Workstream 1 follow-up social score | 5.7 ± 1.0 |
| Workstream 1 baseline activities score | 4.4 ± 1.2 |
| Workstream 1 follow-up activities score | 4.6 ± 1.0 |
| Workstream 1 baseline symptom score | 5.5 ± 0.6 |
| Workstream 1 follow-up symptom score | 5.8 ± 0.6 |
| Workstream 1 baseline emotional score | 5.4 ± 1.6 |
| Workstream 1 follow-up emotional score | 5.4 ± 1.4 |
| Workstream 1 baseline total score | 4.9 ± 1.1 |
| Workstream 1 follow-up total score | 5.1 ± 1.0 |
| Workstream 2 baseline pain score | 3.7 ± 1.2 |
| Workstream 2 follow-up pain score | 4.5 ± 1.1 |
| Workstream 2 baseline social score | 5.2 ± 1.7 |
| Workstream 2 follow-up social score | 5.4 ± 1.8 |
| Workstream 2 baseline activities score | 4.3 ± 1.2 |
| Workstream 2 follow-up activities score | 4.7 ± 1.2 |
| Workstream 2 baseline symptom score | 4.9 ± 1.3 |
| Workstream 2 follow-up symptom score | 5.4 ± 1.0 |
| Workstream 2 baseline emotional score | 5.2 ± 1.3 |
| Workstream 2 follow-up emotional score | 5.5 ± 1.4 |
| Workstream 2 baseline total score | 4.6 ± 1.1 |
| Workstream 2 follow-up total score | 5.0 ± 1.1 |
The index or ratio of the pressure in the ankle compared with the arm.
| Index | High-Intensity Interval Training |
|---|---|
| Workstream 1 baseline | 0.76 ± 0.22 |
| Workstream 1 post- intervention follow-up | 0.78 ± 0.19 |
| Workstream 1 - 4-week post-intervention follow-up | 0.74 ± 0.20 |
| Workstream 1 - 12-week post-intervention follow-up | 0.80 ± 0.20 |
| Workstream 2 baseline | 0.74 ± 0.19 |
| Workstream 2 post-intervention follow-up | 0.76 ± 0.14 |
| Workstream 2 - 4-week post-intervention follow-up | 0.78 ± 0.12 |
| Workstream 2 - 12-week post-intervention follow-up | 0.74 ± 0.14 |
Peak power output assessed via CPET
| Watts | High-Intensity Interval Training |
|---|---|
| Workstream 1 - baseline peak power output | 94.9 ± 26.1 |
| Workstream - 1 post-intervention peak power output | 103.7 ± 30.4 |
| Workstream 1 - 4-weeks post-intervention follow-up peak power output | 98.7 ± 23.4 |
| Workstream 1 - 12-week post-intervention follow-up peak power output | 102.7 ± 30.8 |
| Workstream 2 - baseline peak power output | 101.6 ± 39.4 |
| Workstream 2 - post-intervention follow-up peak power output | 106.0 ± 43.0 |
| Workstream 2 - 4-weeks post-intervention follow-up peak power output | 112.0 ± 44.5 |
| Workstream 2 - 12-weeks post-intervention follow-up peak power output | 114.1 ± 45.5 |
assessment of the distance that the patient can currently walk before experiencing claudication pain.
| metres | High-Intensity Interval Training |
|---|---|
| Workstream 1 baseline | 114.1 ± 75.4 |
| Workstream 1 Post-intervention follow-up | 141.3 ± 62.4 |
| Workstream 1 - 4-week post intervention follow-up | 172.4 ± 103.5 |
| Workstream 1 - 12-week post intervention follow-up | 216.3 ± 163.2 |
| Workstream 2 baseline | 142.5 ± 95.5 |
| Workstream 2 Post-intervention follow-up | 218.6 ± 166.6 |
| Workstream 2 - 4-week post intervention follow-up | 212.7 ± 173.8 |
| Workstream 2 - 12-week post intervention follow-up | 276.0 ± 214.7 |
Ventilatory anaerobic threshold assessed via cardiopulmonary exercise testing
| ml/kg/min | High-Intensity Interval Training |
|---|---|
| Workstream 1 - baseline VAT | 9.8 ± 1.7 |
| Workstream 1 - post-intervention follow-up VAT | 10.2 ± 1.7 |
| Workstream 1 - 4-week post-intervention follow-up VAT | 10.0 ± 1.3 |
| Workstream 1 - 12-week post-intervention follow-up VAT | 9.4 ± 1.4 |
| Workstream 2 - baseline VAT | 10.0 ± 1.9 |
| Workstream 2 - post-intervention follow-up VAT | 10.4 ± 2.2 |
| Workstream 2 - 4-week post-intervention follow-up VAT | 9.8 ± 2.1 |
| Workstream 2 - 12-week post-intervention follow-up VAT | 10.1 ± 2.2 |
Patient reported quality of life using the SF-36 SF-36 is a 36-Item Short Form Health Survey questionnaire. It consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability. The higher the score the less disability.
| units on a scale | High-Intensity Interval Training |
|---|---|
| Workstream 1 - 4-week follow-up physical functioning | 61.9 ± 20.1 |
| Workstream 1 - 12-week follow-up physical functioning | 64.1 ± 20.2 |
| Workstream 1 - 4-week follow-up role physical | 61.5 ± 30.9 |
| Workstream 1 - 12-week follow-up follow-up role physical | 62.5 ± 26.8 |
| Workstream 1 - 4-week follow-up pain | 53.2 ± 19.6 |
| Workstream 1 - 12-week follow-up pain | 54.1 ± 24.7 |
| Workstream 1 - 4-week follow-up general health | 47.4 ± 13.9 |
| Workstream 1 - 12-week follow-up general health | 53.5 ± 19.3 |
| Workstream 1 - 4-week follow-up vitality | 51.0 ± 17.5 |
| Workstream 1 - 12-week follow-up vitality | 55.1 ± 7.3 |
| Workstream 1 - 4-week follow-up social functioning | 84.6 ± 20.5 |
| Workstream 1 - 12-week follow-up social functioning | 85.0 ± 17.5 |
| Workstream 1 - 4-week follow-up role emotional | 80.8 ± 31.6 |
| Workstream 1 - 12-week follow-up role emotional | 76.5 ± 23.8 |
| Workstream 1 - 4-week follow-up mental health | 71.2 ± 15.2 |
| Workstream 1 - 12-week follow-up mental health | 71.8 ± 15.2 |
| Workstream 1 - 4-week follow-up PCS | 40.9 ± 8.4 |
| Workstream 1 - 12-week follow-up PCS | 38.8 ± 15.4 |
| Workstream 1 - 4 week follow-up MCS | 51.5 ± 9.3 |
| Workstream 1 - 12-week follow-up MCS | 46.8 ± 17.3 |
| Workstream 2 - 4-week follow-up physical functioning | 61.7 ± 19.9 |
| Workstream 2 - 12-week follow-up physical functioning | 61.5 ± 20.3 |
| Workstream 2 - 4-week follow-up role physical | 63.9 ± 24.5 |
| Workstream 2 - 12-week follow-up role physical | 57.3 ± 23.4 |
| Workstream 2 - 4-week pain | 55.6 ± 20.3 |
| Workstream 2 - 12-week follow-up pain | 57.5 ± 23.6 |
| Workstream 2 - 4-week follow-up general health | 54.6 ± 18.1 |
| Workstream 2 - 12-week follow-up general health | 53.2 ± 19.5 |
| Workstream 2 - 4-week follow-up vitality | 54.9 ± 20.7 |
| Workstream 2 - 12 -week follow-up vitality | 54.8 ± 22.0 |
| Workstream 2 - 4-week follow-up social functioning | 79.9 ± 25.4 |
| Workstream 2 - 12-week follow-up social functioning | 76.5 ± 27.8 |
| Workstream 2 4-week follow-up role emotional | 77.3 ± 26.5 |
| Workstream 2 - 12-week follow-up role emotional | 77.7 ± 26.5 |
| Workstream 2 4-week follow-up mental health | 78.9 ± 17.4 |
| Workstream 2 - 12-week follow-up mental health | 78.0 ± 18.6 |
| Workstream 2 - 4-week follow-up PCS | 41.7 ± 7.5 |
| Workstream 2 - 12-week follow-up PCS | 41.0 ± 8.6 |
| Workstream 2 - 4-week follow-up MCS | 52.5 ± 10.0 |
| Workstream 2 - 12-week follow-up MCS | 52.3 ± 11.2 |
VascuQoL includes 25 items subdivided into 5 domains and a sum score is also calculated by dividing the total score by 25. Each domain and the total score range from 1 to 7 with 1 representing the worst score and 7 the best.
| units on a scale | High-Intensity Interval Training |
|---|---|
| Workstream 1 - 4-week follow-up pain score | 4.7 ± 1.7 |
| Workstream 1 -12-week follow-up pain score | 5.4 ± 1.2 |
| Workstream 1 - 4-week follow-up social score | 6.3 ± 1.1 |
| Workstream 1 - 12-week follow-up social score | 6.4 ± 0.9 |
| Workstream 1 - 4-week follow-up activities score | 5.2 ± 1.0 |
| Workstream 1 - 12-week follow-up activities score | 5.2 ± 1.2 |
| Workstream 1 - 4-week follow-up symptom score | 5.8 ± 0.6 |
| Workstream 1 - 12-week follow-up symptom score | 5.9 ± 0.7 |
| Workstream 1 4-week follow-up emotional score | 6.0 ± 1.0 |
| Workstream 1 - 12-week follow-up emotional score | 6.4 ± 0.4 |
| Workstream 1 - 4-week total score | 5.6 ± 1.0 |
| Workstream 1 - 12-week follow-up total score | 5.8 ± 0.7 |
| Workstream 2 4-week follow-up pain score | 4.8 ± 1.3 |
| Workstream 2 - 12-week follow-up pain score | 4.6 ± 1.3 |
| Workstream 2 - 4-week follow-up social score | 5.5 ± 1.6 |
| Workstream 2 - 12-week follow-up social score | 5.4 ± 1.7 |
| Workstream 2 4-week follow-up activities score | 4.9 ± 1.2 |
| Workstream 2 - 12-week follow-up activities score | 4.7 ± 1.1 |
| Workstream 2 4-week follow-up symptom score | 5.3 ± 1.2 |
| Workstream 2 - 12-week follow-up symptom score | 5.2 ± 1.2 |
| Workstream 2 4-week follow-up emotional score | 5.7 ± 1.3 |
| Workstream 2 - 12-week follow-up emotional score | 5.5 ± 1.1 |
| Workstream 2 - 4-week follow-up total score | 5.2 ± 1.2 |
| Workstream 2 - 12-week follow-up total score | 5.0 ± 1.1 |
Collected over From enrollment to 18 weeks later for each patient.. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| High-Intensity Interval Training | 0/70 (0%) | 1/70 (1.4%) | 10/70 (14.3%) |
| Event | High-Intensity Interval Training |
|---|---|
| Thrombosed popliteal aneurysmVascular disorders | 1/70 |
| Event | High-Intensity Interval Training |
|---|---|
| Post-exercise dizzinesGeneral disorders | 6/70 |
| Dull chest acheCardiac disorders | 1/70 |
| Back spasmMusculoskeletal and connective tissue disorders | 1/70 |
| HeadacheGeneral disorders | 1/70 |
| Hypertensive CPET responseCardiac disorders | 1/70 |
Baseline characteristics broken down by workstream
| Age, Continuous(years) | High-Intensity Interval Training (Workstream 1) | High-Intensity Interval Training (Workstream 2) | Total |
|---|---|---|---|
| Mean | 69 ± 9 | 69 ± 8 | 69 ± 9 |
| Sex: Female, Male(Participants) | High-Intensity Interval Training (Workstream 1) | High-Intensity Interval Training (Workstream 2) | Total |
|---|---|---|---|
| Female | 7 | 5 | 12 |
| Male | 23 | 35 | 58 |
| Race and Ethnicity Not Collected(Participants) | High-Intensity Interval Training (Workstream 1) | High-Intensity Interval Training (Workstream 2) | Total |
|---|---|---|---|
| Count of participants | — | — | 0 |
| Height(cm) | High-Intensity Interval Training (Workstream 1) | High-Intensity Interval Training (Workstream 2) | Total |
|---|---|---|---|
| Mean | 168.5 ± 7.2 | 169.1 ± 10.0 | 168.7 ± 8.3 |
| Weight(kg) | High-Intensity Interval Training (Workstream 1) | High-Intensity Interval Training (Workstream 2) | Total |
|---|---|---|---|
| Mean | 81.6 ± 16.2 | 79.9 ± 14.5 | 80.6 ± 15.2 |
| body mass index (BMI)(kg/m^2) | High-Intensity Interval Training (Workstream 1) | High-Intensity Interval Training (Workstream 2) | Total |
|---|---|---|---|
| Mean | 28.5 ± 4.0 | 28.0 ± 3.9 | 28.2 ± 3.9 |
| Systolic blood pressure(mmHg) | High-Intensity Interval Training (Workstream 1) | High-Intensity Interval Training (Workstream 2) | Total |
|---|---|---|---|
| Mean | 146 ± 20 | 146 ± 20 | 146 ± 19 |
| Diastolic blood pressure(mmHg) | High-Intensity Interval Training (Workstream 1) | High-Intensity Interval Training (Workstream 2) | Total |
|---|---|---|---|
| Mean | 79 ± 8 | 81 ± 13 | 80 ± 11 |
5 further baseline measures are reported on the registry.
Documents are hosted by the registry — open the source record to download them.
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Hull University Teaching Hospitals NHS Trust