Ignite Creation Date:
2024-05-05 @ 10:11 PM
Last Modification Date:
2024-10-26 @ 10:14 AM
Study NCT ID:
NCT01047410
Status:
COMPLETED
Last Update Posted:
2018-08-31
First Post:
2010-01-11
Brief Title:
ACtive Care After Transplantation the ACT Study
Sponsor:
University Medical Center Groningen
Organization:
University Medical Center Groningen
Study Overview
Official Title:
ACtive Care After Transplantation a Lifestyle Intervention in Renal Transplant Recipients
Status:
COMPLETED
Status Verified Date:
2018-08
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:
ACT
Brief Summary:
The aim of the present study is to compare the outcomes of standard care to the effects of exercise alone and exercise combined with nutrition counseling on post-transplantation weight gain and quality of life in renal transplant recipients RTR The primary outcome is subdomain physical functioning of quality of life SF-36 PFS
Secondary outcomes include other evaluations of quality of life SF-36 KDQOL-SF EQ-5D objective measures of physical functioning aerobic capacity and muscle strength level of physical activity gain in adiposity body fat percentage by bio-electrical impedance assessment BMI waist circumference and cardiometabolic risk factors blood pressure lipids glucose metabolism Additionally it is planned to study data on renal function medical history medication psychological factors motivation kinesiophobia coping style nutrition knowledge nutrition intake nutrition status fatigue work participation process evaluation and cost-effectiveness
Secondary outcomes include other evaluations of quality of life SF-36 KDQOL-SF EQ-5D objective measures of physical functioning aerobic capacity and muscle strength level of physical activity gain in adiposity body fat percentage by bio-electrical impedance assessment BMI waist circumference and cardiometabolic risk factors blood pressure lipids glucose metabolism Additionally it is planned to study data on renal function medical history medication psychological factors motivation kinesiophobia coping style nutrition knowledge nutrition intake nutrition status fatigue work participation process evaluation and cost-effectiveness
Detailed Description:
Patient and graft survival in the first year after renal transplantation have improved substantially over the last decade but long-term graft loss and patient mortality have remained high It is increasingly recognized that the alarmingly poor cardio-metabolic risk profile in renal transplant recipients RTR plays a main role in long-term outcome Improvement of long-term outcome will require specific efforts to improve cardio-metabolic profile and its complications Importantly the substantial increase in body weight and body fat that occurs after transplantation is a major trigger for the poor cardiometabolic profile in the RTR including post-transplant diabetes and metabolic syndrome
The increase in body weight is mostly fat tissue and typically around 9-10 kg Most of this weight gain 90 occurs in the first year after transplantation Recent data indicate that steroid avoidance could not prevent this early increase in adiposity This warrants specific focus on lifestyle factors ie diet and physical activity In the UMCG RTR cohort we found that a lack of physical activity was related to a worse cardiometabolic profile and was an independent predictor of mortality Moreover the substantial increase in fat massweight gain was strongly related to low physical activity high intake of energy-dense drinks low consumption of vegetables to increased plasma triglycerides and the metabolic syndrome The intake of salt and saturated fat was high and fibre intake was low indicating dietary habits that deviate substantially from recommendations for a healthy diet Thus both physical activity and dietary habits are important targets for lifestyle intervention in RTR
Lasting improvements in lifestyle are notoriously difficult to obtain but in recent years substantial intervention expertise has been developed in other high risk groups including prediabetes It is now established that for long term purposes prevention of excessive weight gain is more effective than treatment of weight excess Since in RTR most of the weight is gained in the first year after transplantation prevention is a very promising approach Moreover data in prediabetes suggest that combined intervention targeting both diet and physical activity may be particularly effective to this purpose
Therefore our aim is to investigate the effects on quality of life by a combined diet-and-physical activity program in RTR in the first year after transplantation
This randomized controlled intervention study will use a combined diet-and-physical activity approach After hospital discharge for transplantation 219 patients will be randomized to three either a control groups one group who will receive standard care one group will be exposed to a 3-month exercise program followed by individual counselling and one group will be exposed to the exercise program dietary or to intervention followed by individual counselling The individual counselling is to consolidate the achieved improvements in diet and physical activity and will be provided until 15 months after inclusion This counselling is based on theories of behavioural change and motivational interviewing Daily physical activity is evaluated with a pedometer and dietary habits by questionnaires and food records
The increase in body weight is mostly fat tissue and typically around 9-10 kg Most of this weight gain 90 occurs in the first year after transplantation Recent data indicate that steroid avoidance could not prevent this early increase in adiposity This warrants specific focus on lifestyle factors ie diet and physical activity In the UMCG RTR cohort we found that a lack of physical activity was related to a worse cardiometabolic profile and was an independent predictor of mortality Moreover the substantial increase in fat massweight gain was strongly related to low physical activity high intake of energy-dense drinks low consumption of vegetables to increased plasma triglycerides and the metabolic syndrome The intake of salt and saturated fat was high and fibre intake was low indicating dietary habits that deviate substantially from recommendations for a healthy diet Thus both physical activity and dietary habits are important targets for lifestyle intervention in RTR
Lasting improvements in lifestyle are notoriously difficult to obtain but in recent years substantial intervention expertise has been developed in other high risk groups including prediabetes It is now established that for long term purposes prevention of excessive weight gain is more effective than treatment of weight excess Since in RTR most of the weight is gained in the first year after transplantation prevention is a very promising approach Moreover data in prediabetes suggest that combined intervention targeting both diet and physical activity may be particularly effective to this purpose
Therefore our aim is to investigate the effects on quality of life by a combined diet-and-physical activity program in RTR in the first year after transplantation
This randomized controlled intervention study will use a combined diet-and-physical activity approach After hospital discharge for transplantation 219 patients will be randomized to three either a control groups one group who will receive standard care one group will be exposed to a 3-month exercise program followed by individual counselling and one group will be exposed to the exercise program dietary or to intervention followed by individual counselling The individual counselling is to consolidate the achieved improvements in diet and physical activity and will be provided until 15 months after inclusion This counselling is based on theories of behavioural change and motivational interviewing Daily physical activity is evaluated with a pedometer and dietary habits by questionnaires and food records
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