Plain English Summary
Background and study aims
When we stand up gravity pulls blood into our legs, lowering our blood pressure (BP). Our body must react to keep blood flowing to the brain, when this process fails we develop orthostatic hypotension (OH). This is very common and debilitating in older people. This population are keen to avoid further medication and have prioritised non-drug therapies for research. When we tense our leg muscles, blood is forced back up towards the head (this is the skeletal muscle pump). This improves BP in 44% of older people with OH. The aim of this ‘proof of concept’ study is to see if the skeletal muscle pump can become more effective by strengthening the leg muscles.
Who can participate?
Older people, aged over 60, with orthostatic hypotension and who are able to stand
What does the study involve?
Participants are randomly allocated to either 2, 3, or 4 weeks of baseline observation. Then all participants receive an individualised 8-week leg strengthening exercise programme, which they perform at home. A research assistant (RA) visits participants each week to monitor BP, strength and exercise progress. One month later the outcomes are measured again and they are offered an interview to explore whether the intervention was acceptable and how it could be improved. Participants also visit the Freeman Hospital four times over the course of the study to assess changes in the skeletal muscle pump. This is done by applying a large blood pressure cuff around the leg while contracting the muscles.
What are the possible benefits and risks of participating?
If the exercise does improve the standing BP, the results will be used to develop a clinical trial. The study hopes to benefit people in the future but will be of no personal benefit to participants. The main risk is the inconvenience of research visits. There may some muscle soreness from the exercise programme.
Where is the study run from?
The Newcastle upon Tyne Hospitals NHS Foundation Trust (UK)
When is the study starting and how long is it expected to run for?
December 2017 to September 2020
Who is funding the study?
NIHR Newcastle Biomedical Research Centre (UK)
Who is the main contact?
Dr James Frith
james.frith@newcastle.ac.uk
Trial website
Contact information
Type
Scientific
Primary contact
Dr James Frith
ORCID ID
http://orcid.org/0000-0002-6491-3701
Contact details
Principal Investigator
Institute of Cellular Medicine
Newcastle University
Newcastle upon Tyne
NE2 4HH
United Kingdom
+44 (0)191 208 6000
james.frith@ncl.ac.uk
Additional identifiers
EudraCT number
Nil known
ClinicalTrials.gov number
Nil known
Protocol/serial number
R&D08657
Study information
Scientific title
Targeting the skeletal muscle pump to aid standing in elders with postural hypotension
Acronym
TASKMASTER
Study hypothesis
Improving the strength of the skeletal muscles in the lower limbs in older people with OH will result in a more effective skeletal muscle pump, reducing pooling of blood, and increasing their standing blood pressure.
Ethics approval
Approved 11/05/2008, North East - York Research Ethics Committee (NHSBT Newcastle Blood Donor Centre, Holland Drive, Newcastle upon Tyne, NE2 4NQ, UK; Tel: +44 (0)207 1048091; Email: nrescommittee.northeast-york@nhs.net), REC ref: 18/NE/0173
Study design
Interventional case series
Primary study design
Interventional
Secondary study design
Non randomised study
Trial setting
Home
Trial type
Treatment
Patient information sheet
Condition
Orthostatic hypotension
Intervention
Lower limb strengthening exercises:
1. Duration: 8 weeks
2. Frequency: four times per week
3. Intensity: 5-minute warm-up, 30-minute strength exercises, 5-minute cool-down. Challenging, individualised with progressive difficulty, using graded resistance bands
4. Type: moderate lower limb strength exercises, including, sit-to-stand, heel raises, knee extension, hip adduction and abduction and ‘pelvic tilting’ in a seated position
5. Equipment: graded resistance bands
6. Special considerations: given the orthostatic symptoms, exercise will begin in the seated position, progressing to standing position, catered to individual’s needs
The researchers will recruit 15 older people with OH and monitor their BP, muscle strength and skeletal muscle pump efficiency before, during and after an exercise programme. They will randomise participants to either two, three, or four weeks of baseline observation. Then all participants will receive an individualised 8-week leg strengthening exercise programme, which they will perform at home. A research assistant (RA) will visit participants each week to monitor BP, strength and exercise progress. One month later the outcomes will be measured again and they will be offered a qualitative interview to explore whether the intervention was acceptable and how it could be improved. Participants will also visit the Freeman Hospital four times over the course of the study to assess changes in the skeletal muscle pump. This is done by applying a large blood pressure cuff around the leg while contracting the muscles. The analysis will focus on clinical rather than statistical significance. If the exercise does improve the standing BP, the results will be used to develop a clinical trial.
Intervention type
Behavioural
Phase
Drug names
Primary outcome measure
Systolic BP drop upon standing, measured using a non-invasive, continuous BP monitor (Taskforce, CNSystems) at baseline and completion (12 weeks)
Secondary outcome measures
Measured at baseline and 12 weeks:
1. Calf muscle strength measured using a dynamometer
2. Ejection fraction and refill time of blood from the right and left calf, measured using air plethysmography
3. Transcutaneous tissue oxygen saturation (TOS): anterior muscle area, measured using optical TOS probe (LEA O2C)
4. Venous return (the volume of venous blood returning to the heart), measured using impedance cardiography (Taskforce CNSystems)
5. Peripheral resistance (vasodilation due to muscle activity) measured using impedance cardiography (Taskforce CNSystems)
6. Symptoms during standing measured using Orthostatic Hypotension Questionnaire 3
Exploratory outcome measures:
1. Adherence to the intervention assessed using self-directed exercise diary at 12 weeks
2. Safety assessed using self-directed exercise diary at 12 weeks
3. Acceptability of and barriers to the intervention assessed using qualitative interviews at 12 weeks
Overall trial start date
04/12/2017
Overall trial end date
30/09/2020
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
1. Older people, aged over 60 years
2. With a clinical diagnosis of orthostatic hypotension
3. Who are able to stand
Participant type
Patient
Age group
Senior
Gender
Both
Target number of participants
10
Participant exclusion criteria
1. Unable to participate in physical therapy
2. Acute illness requiring hospitalisation within previous 6 weeks
3. Any physical or cognitive impairment which would prevent engagement with self-directed physical therapy, or ability to follow instructions and complete assessments
4. Receiving physical therapy in other settings, or having received therapy in the previous 12 weeks which involved the lower limbs, or performs regular strengthening exercises of the lower limb (e.g. regular attendance at the gym)
5. Ulceration to the lower limbs
6. Participants who wear compression garments will be required to remove these for assessments
Recruitment start date
01/09/2018
Recruitment end date
30/11/2019
Locations
Countries of recruitment
United Kingdom
Trial participating centre
The Newcastle upon Tyne Hospitals NHS Foundation Trust
NE1 4LP
United Kingdom
Sponsor information
Organisation
Newcastle upon Tyne Hospitals NHS Foundation Trust
Sponsor details
Queen Victoria Road
Newcastle upon Tyne
NE1 4LP
United Kingdom
+44 (0)1912086161
james.frith@ncl.ac.uk
Sponsor type
Hospital/treatment centre
Website
Funders
Funder type
Government
Funder name
NIHR Newcastle Biomedical Research Centre
Alternative name(s)
Newcastle NIHR Biomedical Research Centre, Newcastle Biomedical Research Centre
Funding Body Type
private sector organisation
Funding Body Subtype
Research institutes and centers
Location
United Kingdom
Results and Publications
Publication and dissemination plan
The study protocol may be made available upon reasonable request to the PI. Planned publication of the results in a geriatric medicine journal in 2021.
IPD sharing statement
Data will not be available as participants have not provided consent specifically for their data to be used outside of this study.
Intention to publish date
30/09/2021
Participant level data
Not expected to be available
Basic results (scientific)
Publication list