Hemodialysis ComplicationFITNESSNCT03071107
Frailty Intervention Trial in End-Stage Patients on Dialysis
A study testing Multi-disciplinary intervention in people with Hemodialysis Complication and Nutritional Deficiency, run by Adnan Sharif at 1 site in United Kingdom.
Trial summary
The proposed investigation for this study aims to; 1) understand the prevalence and outcomes associated with frailty among haemodialysis patients; 2) ascertain the best frailty assessment tool for haemodialysis patients, and; 3) design a clinical study to explore the feasibility of facilitating, recruiting and… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hemodialysis Complication, Nutritional Deficiency, Physical Activity
- What is being tested?
- Multi-disciplinary intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 1 Dec 2017to Aug 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- On hemodialysis
Who cannot join
- Inability to give consent
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
University Hospitals Birmingham NHS Foundation Trust
Birmingham, West Midlands, B15 2WB
About this study
Official title: Frailty Intervention Trial in End-Stage Patients on Dialysis: A Feasibility Study
The proposed investigation for this study aims to; 1) understand the prevalence and outcomes associated with frailty among haemodialysis patients; 2) ascertain the best frailty assessment tool for haemodialysis patients, and; 3) design a clinical study to explore the feasibility of facilitating, recruiting and executing a multi-disciplinary clinical and psychological intervention to improve frailty status among haemodialysis patients.
Work package 1: Firstly, there is a need to understand the prevalence and spectrum of frailty in a UK haemodialysis cohort and what impact frailty has for haemodialysis patients. To investigate this, the investigators will approach every patient on haemodialysis within the local catchment of haemodialysis units and, after informed consent, clinically phenotype their frailty status (pre- and post-haemodialysis for calculation of variability). The frailty phenotyping will encompass a number of frailty assessments (including the Edmonton Frail Scale, Clinical Frailty Scale from Rookwood score and Fried Frailty scale) to identify the ideal frailty assessment tool. All patients in this observational cohort study will be prospectively monitored for clinical/biochemical outcomes using an informatics-based approach for up to 60 months.
Read more
Work package 2: Building upon the work conducted in work package 1, work package 2 will aim to recruit 50 patients clinically phenotyped with pre-frailty from work package 1 into a feasibility study exploring a multi-disciplinary intervention to improve frailty status. Eligible patients, after informed consent, will be randomised into active or passive intervention. The active intervention will involve a dietitian and physiotherapist who have been trained and accredited with cognitive behavior intervention, utilising established behavioral intervention frameworks, to deliver a multi-disciplinary clinical intervention targeting multiple components of frailty.
The FITNESS project will therefore answer some important unanswered questions regarding frailty among the haemodialysis population and help in the design of a large multi-disciplinary intervention study if deemed feasible.
- Being tested
- Multi-disciplinary intervention
- Medical subject headings
- Malnutrition, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Multi-disciplinary interventionBehavioural
Participants in the intervention group will receive a multifactorial, interdisciplinary, treatment program intended to target pre-frailty for a 4-month period following randomization (physical meetings at 2-monthly time points with telephone consultations between meetings). The interventions will be individually tailored to each participant based on their frailty characteristics at baseline and amended if other problems are identified during the intervention program. This intervention team will consist of a renal dietitian and physiotherapist, both of whom will be trained and accredited in behavioural therapy intervention skills, and will focus on improving nutritional status and physical strength through resistance exercise training. They will be supported by a Clinical Research Fellow who will provide additional medical assessment to determine any reversible medical causes of frailty.
| Study group | Role | What they receive |
|---|---|---|
| Multi-disciplinary intervention arm | Active comparator | Multi-disciplinary intervention on frailty parameters including input from dietitian, physiotherapist and medical team Receives: Behavioral: Multi-disciplinary intervention |
| Control arm | No intervention | Standard of care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility of frailty intervention study in haemodialysis patients
Feasibility of undertaking a full scale clinical intervention trial targeting frail haemodialysis patients
Measured: 6-months
Secondary outcomes (3)
Change in frailty status
Change in frailty score between baseline and end of study
Measured: 6-months
Mortality
Difference in mortality episodes between randomised arms
Measured: 6-months
Hospitalisation
Difference in episodes of hospitalisation between randomised arms
Measured: 6-months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Mar 2017
- Study start1 Dec 2017
- Primary completion15 Jun 2019
- Study completionAug 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Hemodialysis ComplicationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Adnan Sharif
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Adnan Sharif, University Hospital Birmingham NHS Foundation Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03071107
- Sponsor's protocol ID
- FITNESS
- Acronym
- FITNESS
- Status last verified
- Jun 2020
- First submitted
- 25 Feb 2017
- Last updated
- 12 Jun 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Anderson BM, Qasim M, Correa G, Evison F, Gallier S, Ferro CJ, Jackson TA, Sharif A. A clinical frailty scale obtained from MDT discussion performs poorly in assessing frailty in haemodialysis recipients. BMC Nephrol. 2023 Mar 30;24(1):80. doi: 10.1186/s12882-023-03126-0.
PubMed 36997856Anderson BM, Wilson DV, Qasim M, Correa G, Evison F, Gallier S, Ferro CJ, Jackson TA, Sharif A. Ultrasound quadriceps muscle thickness is variably associated with frailty in haemodialysis recipients. BMC Nephrol. 2023 Jan 18;24(1):16. doi: 10.1186/s12882-022-03043-8.
PubMed 36653750Anderson BM, Dutton M, Day E, Jackson TA, Ferro CJ, Sharif A. Frailty Intervention Trial iN End-Stage patientS on haemodialysis (FITNESS): study protocol for a randomised controlled trial. Trials. 2018 Aug 24;19(1):457. doi: 10.1186/s13063-018-2842-x.
PubMed 30143028
Study at a glance
From the registry record, last updated by the sponsor on 12 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Frailty Intervention Trial in End-Stage Patients on Dialysis: A Feasibility Study
- ClinicalTrials.gov ID
- NCT03071107
- Acronym / sponsor ID
- FITNESS / FITNESS
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Adnan SharifUniversity, hospital or other
- Study start
- 1 Dec 2017 (actual)
- Primary completion
- 15 Jun 2019 (actual)
- Study completion
- Aug 2025 (estimated)
- First posted
- 6 Mar 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The proposed investigation for this study aims to; 1) understand the prevalence and outcomes associated with frailty among haemodialysis patients; 2) ascertain the best frailty assessment tool for haemodialysis patients, and; 3) design a clinical study to explore the feasibility of facilitating, recruiting and executing a multi-disciplinary clinical and psychological intervention to improve frailty status among haemodialysis patients.
Work package 1: Firstly, there is a need to understand the prevalence and spectrum of frailty in a UK haemodialysis cohort and what impact frailty has for haemodialysis patients. To investigate this, the investigators will approach every patient on haemodialysis within the local catchment of haemodialysis units and, after informed consent, clinically phenotype their frailty status (pre- and post-haemodialysis for calculation of variability). The frailty phenotyping will encompass a number of frailty assessments (including the Edmonton Frail Scale, Clinical Frailty Scale from Rookwood score and Fried Frailty scale) to identify the ideal frailty assessment tool. All patients in this observational cohort study will be prospectively monitored for clinical/biochemical outcomes using an informatics-based approach for up to 60 months.
Work package 2: Building upon the work conducted in work package 1, work package 2 will aim to recruit 50 patients clinically phenotyped with pre-frailty from work package 1 into a feasibility study exploring a multi-disciplinary intervention to improve frailty status. Eligible patients, after informed consent, will be randomised into active or passive intervention. The active intervention will involve a dietitian and physiotherapist who have been trained and accredited with cognitive behavior intervention, utilising established behavioral intervention frameworks, to deliver a multi-disciplinary clinical intervention targeting multiple components of frailty.
The FITNESS project will therefore answer some important unanswered questions regarding frailty among the haemodialysis population and help in the design of a large multi-disciplinary intervention study if deemed feasible.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Multi-disciplinary intervention arm | Active comparator | Behavioral: Multi-disciplinary interventionMulti-disciplinary intervention on frailty parameters including input from dietitian, physiotherapist and medical team |
| Control arm | No intervention | –Standard of care |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- On hemodialysis
Key exclusion criteria (1 listed)
- Inability to give consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Multi-disciplinary interventionParticipants in the intervention group will receive a multifactorial, interdisciplinary, treatment program intended to target pre-frailty for a 4-month period following randomization (physical meetings at 2-monthly time points with telephone consultations between meetings). The interventions will be individually tailored to each participant based on their frailty characteristics at baseline and amended if other problems are identified during the intervention program. This intervention team will consist of a renal dietitian and physiotherapist, both of whom will be trained and accredited in behavioural therapy intervention skills, and will focus on improving nutritional status and physical strength through resistance exercise training. They will be supported by a Clinical Research Fellow who will provide additional medical assessment to determine any reversible medical causes of frailty. | Behavioural | Multi-disciplinary intervention arm |
Primary outcome
Feasibility of frailty intervention study in haemodialysis patients
Time frame: 6-months
Feasibility of undertaking a full scale clinical intervention trial targeting frail haemodialysis patients
3 secondary outcomes
Change in frailty status
Time frame: 6-months
Mortality
Time frame: 6-months
Hospitalisation
Time frame: 6-months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jun 2020.
- Derived from this study: PubMed 36997856Anderson BM, Qasim M, Correa G, Evison F, Gallier S, Ferro CJ, Jackson TA, Sharif A. A clinical frailty scale obtained from MDT discussion performs poorly in assessing frailty in haemodialysis recipients. BMC Nephrol. 2023 Mar 30;24(1):80. doi: 10.1186/s12882-023-03126-0.
- Derived from this study: PubMed 36653750Anderson BM, Wilson DV, Qasim M, Correa G, Evison F, Gallier S, Ferro CJ, Jackson TA, Sharif A. Ultrasound quadriceps muscle thickness is variably associated with frailty in haemodialysis recipients. BMC Nephrol. 2023 Jan 18;24(1):16. doi: 10.1186/s12882-022-03043-8.
- Derived from this study: PubMed 30143028Anderson BM, Dutton M, Day E, Jackson TA, Ferro CJ, Sharif A. Frailty Intervention Trial iN End-Stage patientS on haemodialysis (FITNESS): study protocol for a randomised controlled trial. Trials. 2018 Aug 24;19(1):457. doi: 10.1186/s13063-018-2842-x.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Multi-disciplinary intervention in people with Hemodialysis Complication and Nutritional Deficiency, run by Adnan Sharif at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 12 Jun 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility of frailty intervention study in haemodialysis patients (time frame: 6-months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03071107, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jun 2020.