Ignite Creation Date:
2024-05-11 @ 8:31 AM
Last Modification Date:
2024-10-26 @ 3:28 PM
Study NCT ID:
NCT06400316
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-05-06
First Post:
2024-01-04
Brief Title:
Muscle Wasting and Rheumatoid Arthritis Flares
Sponsor:
Leeds Beckett University
Organization:
Leeds Beckett University
Study Overview
Official Title:
Preventing Muscle Wasting During Rheumatoid Arthritis Flares A Randomised Controlled Trial
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
People living with Rheumatoid Arthritis RA often present with low muscle mass compared to their healthy counterparts This affects their mobility overall health and quality of life Even though low muscle mass in RA has been recognised for decades it is still highly prevalent and very little is known about its development progression and potential management
The researchers hypothesise that flares of disease activity trigger acute events of muscle wasting due to high inflammation and reduced mobility This is commonly observed in bed rest studies and people hospitalised for various reasons If this holds true for RA it would point towards a stepwise development of RC and potentially allow for time-targeted management of it
A potential method to manage it is through the use of nutritional supplements Specifically amino acid supplementation commonly used by athletes or people wanting to increase muscle mass during and shortly after a flare may counteract some of the muscle wasting and allow for better long-term mobility and quality of life for people living with RA
This study aims to investigate aspects of muscle health changes following a disease flare-up in people with Rheumatoid Arthritis RA and test potential interventions to minimise any such changes The investigators will randomly assign participants to a standard care or a nutritional supplementation group and assess aspects of body composition muscle health disease activity and inflammation on five occasions over a 3-month period
The researchers hypothesise that flares of disease activity trigger acute events of muscle wasting due to high inflammation and reduced mobility This is commonly observed in bed rest studies and people hospitalised for various reasons If this holds true for RA it would point towards a stepwise development of RC and potentially allow for time-targeted management of it
A potential method to manage it is through the use of nutritional supplements Specifically amino acid supplementation commonly used by athletes or people wanting to increase muscle mass during and shortly after a flare may counteract some of the muscle wasting and allow for better long-term mobility and quality of life for people living with RA
This study aims to investigate aspects of muscle health changes following a disease flare-up in people with Rheumatoid Arthritis RA and test potential interventions to minimise any such changes The investigators will randomly assign participants to a standard care or a nutritional supplementation group and assess aspects of body composition muscle health disease activity and inflammation on five occasions over a 3-month period
Detailed Description:
This study aims to investigate aspects of muscle health changes following a disease flare-up in people with Rheumatoid Arthritis RA and test potential interventions to minimise any such changes
RA is the most common inflammatory arthritis manifesting mainly as joint swelling and pain limiting mobility and eventually leading to loss of functional capacity RA also has severe extra-articular manifestations 1 affecting several tissues in the body including skeletal muscle 2 People living with RA often present with an adverse body composition profile compared to the general population characterised by low muscle mass at the presence of unchanged or even increased overall weight 3 This condition termed Rheumatoid Cachexia may affect up to 2 out of 3 people with RA and associates with active disease further reductions in mobility and low quality of life 4
While rheumatoid cachexia has been studied extensively the course of its development as well as potential causes or contributors to it are poorly understood Inflammation 5 as well as lifestyle factors such as energy intake and physical activity may contribute to the observed body composition changes 6
People living with RA often experience flares of disease activity where high levels of inflammation cause an acute exaggeration of symptoms leading to very low levels of mobility This is commonly treated with corticosteroid injections which will rapidly reduce inflammation and allow the patient to regain mobility However that short period of high inflammatory load and low mobility may acutely affect muscle characteristics Indeed critically ill patients may lose up to 2 of skeletal muscle per day during the first week of hospitalisation 7 This rapid decline in muscle health has been recently termed Acute sarcopenia AS by the European working group in sarcopenia and older persons EWGSOP 8 Furthermore recent work within this research team is currently under review Aldrich et al 2023 under review demonstrating the rapid decline of muscle mass and quality in people suffering with various diseases Additionally corticosteroids themselves may further contribute to muscle wasting in RA 9 Yet the acute effects of flares and their treatment on muscle health in people with RA are not known
Acute deterioration of muscle health following a flare may point towards a stepwise development of rheumatoid cachexia ie bouts of acute deterioration that accumulate over time in steps rather than a continuous slow loss - which is the current understanding for the development of sarcopenia the age-related muscle wasting This would allow for target and potentially short-term interventions that could limit or even reverse muscle deterioration during a flare and help people with RA better maintain their functionality
Exercise and particularly resistance exercise is the most effective way to increase muscle mass strength and quality However people during and shortly after a flare may not be willing to engage in such an intervention Additional complexities around gym or home-based delivery familiarisation and safe execution render this a complex intervention with potentially limited applicability
Nutritional supplementation on the other hand is readily available relatively cheap and easy to administer Specifically for muscle health amino acid supplementation and particularly with leucine has been shown to improve muscle mass and muscle function in older men and women 10 Moreover previous research has shown that these amino acid supplements do not suppress appetite are well tolerated and easy to consume Finally recent unpublished data from this laboratory suggest that amino acid concentrations in the blood following consumption alongside a meal remain elevated vs placebo for over 2 hours This indicates that consuming two supplements per day would provide sufficient amino acids to induce beneficial effects on muscle health
Therefore the aims of this investigation are
1 To understand the effects of acute RA flares on muscle health
2 To assess the efficacy of amino acid supplementation vs standard care in maintaining muscle health
RA is the most common inflammatory arthritis manifesting mainly as joint swelling and pain limiting mobility and eventually leading to loss of functional capacity RA also has severe extra-articular manifestations 1 affecting several tissues in the body including skeletal muscle 2 People living with RA often present with an adverse body composition profile compared to the general population characterised by low muscle mass at the presence of unchanged or even increased overall weight 3 This condition termed Rheumatoid Cachexia may affect up to 2 out of 3 people with RA and associates with active disease further reductions in mobility and low quality of life 4
While rheumatoid cachexia has been studied extensively the course of its development as well as potential causes or contributors to it are poorly understood Inflammation 5 as well as lifestyle factors such as energy intake and physical activity may contribute to the observed body composition changes 6
People living with RA often experience flares of disease activity where high levels of inflammation cause an acute exaggeration of symptoms leading to very low levels of mobility This is commonly treated with corticosteroid injections which will rapidly reduce inflammation and allow the patient to regain mobility However that short period of high inflammatory load and low mobility may acutely affect muscle characteristics Indeed critically ill patients may lose up to 2 of skeletal muscle per day during the first week of hospitalisation 7 This rapid decline in muscle health has been recently termed Acute sarcopenia AS by the European working group in sarcopenia and older persons EWGSOP 8 Furthermore recent work within this research team is currently under review Aldrich et al 2023 under review demonstrating the rapid decline of muscle mass and quality in people suffering with various diseases Additionally corticosteroids themselves may further contribute to muscle wasting in RA 9 Yet the acute effects of flares and their treatment on muscle health in people with RA are not known
Acute deterioration of muscle health following a flare may point towards a stepwise development of rheumatoid cachexia ie bouts of acute deterioration that accumulate over time in steps rather than a continuous slow loss - which is the current understanding for the development of sarcopenia the age-related muscle wasting This would allow for target and potentially short-term interventions that could limit or even reverse muscle deterioration during a flare and help people with RA better maintain their functionality
Exercise and particularly resistance exercise is the most effective way to increase muscle mass strength and quality However people during and shortly after a flare may not be willing to engage in such an intervention Additional complexities around gym or home-based delivery familiarisation and safe execution render this a complex intervention with potentially limited applicability
Nutritional supplementation on the other hand is readily available relatively cheap and easy to administer Specifically for muscle health amino acid supplementation and particularly with leucine has been shown to improve muscle mass and muscle function in older men and women 10 Moreover previous research has shown that these amino acid supplements do not suppress appetite are well tolerated and easy to consume Finally recent unpublished data from this laboratory suggest that amino acid concentrations in the blood following consumption alongside a meal remain elevated vs placebo for over 2 hours This indicates that consuming two supplements per day would provide sufficient amino acids to induce beneficial effects on muscle health
Therefore the aims of this investigation are
1 To understand the effects of acute RA flares on muscle health
2 To assess the efficacy of amino acid supplementation vs standard care in maintaining muscle health
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None