Condition category
Circulatory System
Date applied
19/12/2016
Date assigned
20/12/2016
Last edited
20/12/2016
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
When standing upright, gravity means that blood falls towards the feet, and so the body must respond by increasing blood pressure to keep blood flowing to the brain. When this mechanism fails it is known as orthostatic hypotension (OH). It affects 3.5 million older people in the UK and results in a reduced quality of life, high symptom burden (dizziness, falls, blackouts, fatigue) and an increased chance of death. People affected by OH say the research priority should be to improve their quality of life but without more tablets. Currently the non­drug therapies used include drinking a glass of water quickly, compression stockings, and muscle contractions during standing. However, the research studies that suggest they work are small, very low quality and relate to younger people. Given that OH is predominantly a condition of older people it is important to determine whether these therapies work in this age group. The aim of this study is to look at the effectiveness of non-drug therapies for the treatment of OH in older people.

Who can participate?
Adults aged 60 years and over who are able to stand upright and have been diagnosed with OH.

What does the study involve?
All participants attend three study visits. On the first visit, participants undergo a range of tests in order to assess the severity of their OH symptoms and blood pressure drop when standing assessed. On the second visit, participants receive four treatments in a random order, with a 10 minute rest between treatments. The first treatment involves wearing compression stockings (tight stockings) on the lower legs. The second treatment involves having the abdomen compressed using a special binder. The third treatment involves having the abdomen and legs compressed. The fourth treatment involves tensing/contracting the muscles in the legs and buttocks (physical counter-manoeuvres). Each treatment lasts for about 10 minutes and patients are asked to stand up for three minutes afterwards, when they have their blood pressure drop measured. On the third study visit, participants are interviewed about their experiences of the different treatments.

What are the possible benefits and risks of participating?
There are no direct benefits of participating, however the results will help improve knowledge about which non-drug therapies for OH are worthy of further evaluation in a clinical trial to help develop a way of helping people stick to the therapies in the long term. There are no notable risks of participating although for some participants giving up their time to take part may be inconvenient.

Where is the study run from?
Falls and Syncope Service, Royal Victoria Infirmary (UK)

When is the study starting and how long is it expected to run for?
February 2015 to April 2017

Who is funding the study?
National Institute for Health Research (UK)

Who is the main contact?
Mrs Ruth Pearce
ruth.pearce@ncl.ac.uk

Trial website

Contact information

Type

Public

Primary contact

Mrs Ruth Pearce

ORCID ID

http://orcid.org/0000-0002-6491-3701

Contact details

Institute of Cellular Medicine
The Medical School
Newcastle University
Newcastle upon Tyne
NE2 4HH
United Kingdom
+44 191 208 3868
ruth.pearce@ncl.ac.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

19750

Study information

Scientific title

Non­drug therapies for orthostatic hypotension in older people: Determining basic efficacy and acceptability

Acronym

Study hypothesis

The aim of this study is to determine whether non-drug therapies meet a basic level of efficacy in the treatment of orthostatic hypotension (OH) in older people.

Ethics approval

NRES Committee North East – Newcastle & North Tyneside 2, 09/10/2015, ref: 15/NE/0308

Study design

Randomised; Interventional; Design type: Treatment, Device, Psychological & Behavioural

Primary study design

Interventional

Secondary study design

Randomised cross over trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

No participant information sheet available

Condition

Orthostatic hypotension (OH)

Intervention

Stage 1
After provision of informed consent, participants have their height and weight recorded before being invited to lie down on the couch. While supine, the participant will be connected to the monitoring equipment, all of which is external and non-invasive (Taskforce Monitor, CNSystems). There will be four small stickers placed on the individual (one on each shoulder, one on the left hip and one on the right ankle), and three larger stickers (one on the nape of the neck and one over the lower ribs on each side). The stickers will connect to the monitor via wires. There will also be a blood pressure cuff placed on the upper arm, and on the opposite side there will be a small blood pressure cuff on a finger. The participant will rest supine on the couch for 10 minutes.

The following tests will then be performed. At least two minutes rest will occur between tests:
1. Active standing: The participant is assisted into a standing position where they remain for 3 minutes, or sooner if symptoms require them to be seated. Following this test, they will rate the severity of their symptoms during standing using the Orthostatic Hypotension Questionnaire (OHQ).
2. Deep breathing: The participant will be asked to perform six controlled breaths in and out (each breath lasting ideally 10 seconds, but shorter cycles are acceptable).
3. Valsalva: The participant will be asked to blow into a tube for 10-15 seconds.
4. Cold pressor: The participant will be asked to place their hand into a bowl of icy cold water. They remove their hand when it becomes uncomfortable, their blood pressure rises or they manage 60 seconds, whichever occurs first. They will not be expected to continue if it is uncomfortable.

The participant will then rest in the seated position for 10 minutes to regain a stable blood pressure. The participant will be provided with a beaker of 480 ml of water, they will be asked to consume as much as they can manage within 5 minutes. The participant will then remain seated for 5 minutes. Then the active stand will be repeated following a 10-minute supine rest. The assessment of water drinking as a therapy is performed separately from the other therapies as it requires a ‘washout’ period. The final part of Visit 1 will be to measure the participant’s leg and abdomen size so that the correctly fitting compression stockings can be administered in stage 2. This visit lasts between 1.5-2 hours.

Stage 2
Once week later, participants attend a second study visit. Upon arrival the procedures will be explained to the participant and opportunity for questions provided. They will begin with a 10-minute supine rest while wearing the same monitoring equipment and will then undergo an active stand to re-establish a baseline blood pressure drop and symptoms for that visit. Following this baseline the participant will receive the following therapies and complete the OHQ questionnaire (symptom section only) after each one:
1. Compression stockings: Lower-limb compression stockings will be fitted to the participant’s legs, they will then rest for 10-minutes and then stand upright for 3 minutes.
2. Abdominal compression: An abdominal binder will then be applied, the participant rests for 10 minutes and the active stand is repeated.
3. Leg and abdominal compression: Leg and abdominal compression are frequently used together, so these will be applied together and assessed during active stand.
4. Physical counter-manoeuvres (PCMs): This means tensing/contracting the muscles in the legs and buttocks (which can be achieved by squeezing the knees together for example).
Each therapy will be administered to each participant in a different order so that any theoretical impact of one therapy persisting over time will not have undue influence over the following therapy. The order of the therapies will be selected randomly (by the research assistant just prior to administering the therapies) from a set of 25 opaque, sealed envelopes (one per participant). There are 24 possible orders so one envelope will be selected at random and it’s contents will be duplicated so that there are only two identical envelopes. This visit lasts approximately 1.5 hours.

Stage 3
Participants are interviewed about their experiences of the therapies to determine whether they are considered acceptable and how we could potentially help people to use them more. A choice of settings will be offered and will include the participant’s own home, a meeting room in the Campus for Ageing and Vitality or Medical School in Newcastle University. Transport for the participant and their friend/family will be provided if required, as will refreshments. The same participants will be interviewed who took part in visit 1 and visit 2 as we would like to discuss their experience of the therapies used in visits 1 and 2. Participants will be welcome to have a friend/family with them during the interviews. It is anticipated that an approximate sample of 20 participants will be sufficient to achieve data saturation. The interviews will be performed by a research assistant (Ruth Pearce) who is highly experienced in working with older people in research settings and in performing qualitative interviews. They will be semi-structured using a topic guide (which will evolve over time being responsive to issues which arise during the interviews). The interviews are expected to last approximately 60 minutes but will stop if they go beyond 90 minutes. The interviews will be recorded on a digital recorder so that they can be later transcribed and analysed.

The research takes place during the three visits only. There are no interventions or changes to treatment between each visit/stage.

Intervention type

Other

Phase

Drug names

Primary outcome measures

Postural systolic blood pressure drop is measured using non-invasive, beat-to-beat monitoring (Taskforce Monitor, CNSystems) at baseline (before intervention) and then during each intervention (visit 1 and visit 2).

Secondary outcome measures

1. Postural diastolic blood pressure drop is measured using non-invasive, beat-to-beat monitoring (Taskforce Monitor, CNSystems) at baseline (before intervention) and then during each intervention (visit 1 and visit 2)
2. Symptoms are measured using the Orthostatic Hypotension Questionnaire Symptom score at baseline and then immediately after orthostatic challenge with each intervention (visit 1 and 2)
3. Acceptability of and barriers to therapy are measured using data from qualitative interviews at visit 3

Overall trial start date

01/02/2015

Overall trial end date

01/04/2017

Reason abandoned

Eligibility

Participant inclusion criteria

1. Aged 60 years or above
2. Clinical diagnosis of orthostatic hypotension (confirmed with a postural drop in systolic/diastolic blood pressure of at least 20/10 mmHg within 3 minutes of standing upright from a supine position).
3. Able to stand upright

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

Planned Sample Size: 25; UK Sample Size: 25

Participant exclusion criteria

1. Age below 60 years
2. Dysphagia or previous episode of aspiration
3. Peripheral vascular disease or lower limb ulceration
4. Any contra-indication to bolus water drinking (such as a fluid restriction, cardiac/renal/liver failure)
5. Unable to provide informed consent

Recruitment start date

09/12/2015

Recruitment end date

11/12/2016

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Royal Victoria Infirmary
Falls and Syncope Service
Newcastle upon Tyne
NE1 4LP
United Kingdom

Sponsor information

Organisation

The Newcastle upon Tyne Hospitals NHS Foundation Trust

Sponsor details

Freeman Hospital
Freeman Road
High Heaton
Newcastle-upon-Tyne
NE7 7DN
United Kingdom
+44 191 282 5959
Trust.R&D@nuth.nhs.uk

Sponsor type

Hospital/treatment centre

Website

Funders

Funder type

Government

Funder name

National Institute for Health Research

Alternative name(s)

NIHR

Funding Body Type

government organisation

Funding Body Subtype

Federal/National Government

Location

United Kingdom

Results and Publications

Publication and dissemination plan

Results will be presented to research participants May 2017. Results will be presented to scientific audiences in peer-review publications and at conferences in 2017-2018.

IPD Sharing plan:
The current data sharing plans for the current study are unknown and will be made available at a later date.

Intention to publish date

31/05/2017

Participant level data

To be made available at a later date

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes