Exercise Therapy for Women With ANOCA
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18+
SponsorNHS Greater Glasgow and Clyde
About this trial
Angina is a feeling of chest pain or discomfort which can happen if there is reduced blood flow to the heart. Patients can experience angina with no obstructive coronary arteries (ANOCA) which is a difficult condition to treat (ie relieve angina) since few randomised, controlled therapy trials have been undertaken for ANOCA. Until now, angina has been mainly studied in men even though women are at least two-fold more likely than men to experience ANOCA.
In 2023, a Scientific Statement from the American Heart Association affirmed that resistance exercise training can improve or maintain muscle mass and strength and confer favourable physiological and clinical effects on cardiovascular disease and risk factors. Resistance exercise has not been assessed in ANOCA and it offers an important opportunity to study non drug alternatives to treatment for women.
This study will use a resistance based exercise programme to investigate if symptoms of ANOCA can be improved in women. It will recruit at least 76 patients (maximum 152 patients) across 13 hospitals in the UK and the Netherlands.
The study will use a randomised wait list control design. This means all participants will be offered the intervention, but the randomisation will decide when they undergo it.
It is part of a platform of trials for women with ANOCA. We are also setting up a drug study called ANOCA Therapy and a cohort study called ANOCA- Diagnosis.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Angina with no obstructive coronary arties (ANOCA)
Myocardial perfusion reserve or coronary flow reserve recorded within three years
Seattle Angina Questionnaire frequency score ≤60
Duke Activity Status Index ≤34
Disqualifiers
Age <18 years
Unable to provide informed consent
- Unable to comply with the protocol
Pregnancy
Trial design
Design model
Parallel
Treatments tested in this trial
Resistance based exercise
BehavioralParticipants will undergo daily resistance based exercise for 8 weeks
Treatment groups
76 Participants
are divided into 2 treatment groupsGroup A: InterventionExperimental treatment 1 intervention
Group B: ControlActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
Seattle Angina Questionnaire
The Seattle Angina Questionnaire a validated 19-item patient-reported survey used to measure coronary artery disease and angina treatment efficacy. Patients will complete on paper or electronically. The scores range from 0 to 100, with higher scores indicating less frequent angina, improved function, and better quality of life.
Time frame
Change from Baseline to Week 9Secondary outcomes
1
Myocardial perfusion reserve (MPR)
The ratio of maximum blood flow in the heart muscle under stress compared to resting flow
Time frame
Change from baseline to week 92
Handgrip strength using hand dynamometer
Measured in Kgs. This is used as a proxy for overall body strength with lower measures indicating less strength.
Time frame
Change from baseline to week 93
Short Physical Performance Battery (SPPB)
Used as a proxy for fitness
Time frame
Change from baseline to week 94
Brief Illness perception Questionnaire (Brief IPQ)
A nine-item scale designed to rapidly assess the cognitive and emotional representations of illness. It consists of 9 items: 8 are scored on a 0-10 scale, and item 9 is an open-ended question assessing perceived causes. The total score (0-80) is calculated by summing the first 8 items, with items 3, 4, and 7 reverse scored. Higher scores generally reflect a more threatening perception of the illness
Time frame
Change from baseline to week 9Sponsors and contacts
Click on the lead sponsor to view all of their trials.
NHS Greater Glasgow and Clyde
Lead sponsor
The University of Glasgow
Collaborator
Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: