The proposed randomized controlled lifestyle intervention studies the effects of an exercise and nutrition intervention in the first year after transplantation on: 1. Exercise capacity, muscle strength, diet, quality of life and social participation…
ID
Source
Brief title
Condition
- Other condition
- Appetite and general nutritional disorders
- Muscle disorders
Synonym
Health condition
overgewicht en deconditionering na niertransplantatie
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
• Quality of life;
• Exercise capacity;
• Muscle strength and muscle mass.
• Cardio Metabolic risk (body composition, metabolic syndrome and insulin
resistance).
r
Secondary outcome
• Daily physical activity;
• Nutritional intake, nutritional status and nutritional knowledge;
• Barriers and success factors for intervention effect on patient level;
• Psychological factors.
Background summary
The patient and graft survival in the first year after renal transplantation
have improved considerably in recent decades . However the long -term outcomes,
are still not optimal for the patient. Cardiovascular diseases are the primary
cause of death after renal transplantation , and also a major cause of
morbidity .The adverse cardio metabolic risk profile after kidney
transplantation plays an important role in this increased risk.
A healthy lifestyle can reduce the cardio metabolic risk after transplantation,
by prevention of post-transplant obesity, metabolic syndrome and
post-transplant diabetes . Lifestyle changes aiming to improve endurance ,
muscular strength and a healthy diet can also contribute to a higher quality of
life after transplantation.
Obesity is a well-known problem after transplantation. In the first year after
transplantation, patients gain on average of 6 kilogram. This gain in weight
entirely consists of an increase in fat mass. The weight gain appears to be
related to both unhealthy diet and lack of exercise, and leads to a less
favorable cardio metabolic risk profile. Lack of exercise after renal
transplantation is a strong predictor of cardiovascular mortality. Previous
research shows that low muscle mass and exercise intolerance are important
determinants of quality of life in renal transplant patients . Change in
lifestyle can improve muscle mass and exercise tolerance, and thereby the
quality of life . Healthy diet and physical activity are important targets for
intervention after renal transplantation. Sustainable changes of lifestyle
habits require specific expertise. Experience in other high-risk groups such as
pre-diabetes patients is valuable. The promising finding in pre-diabetes
patients show that lifestyle measures are effective in the prevention of
diabetes. In renal transplant patients, the greatest weight gain occurs in the
first year after transplantation : the first year after transplantation
therefore offers a ' window of opportunity ' for preventing obesity .
Study objective
The proposed randomized controlled lifestyle intervention studies the effects
of an exercise and nutrition intervention in the first year after
transplantation on:
1. Exercise capacity, muscle strength, diet, quality of life and social
participation.
2. The development of obesity and metabolic risk factors in the first year
after renal transplantation.
Study design
This study is an applied randomized controlled intervention. Participants will
be randomized into three groups: standard care, exercise, exercise and
nutritional intervention.
Intervention
Participants will be randomized over the three research groups : standard care
, exercise group, exercise and nutritional intervention group. The standard
care group receives regular care and advice to be physically active. The
exercise intervention group (3 months exercise program with 15 months lifestyle
counseling) aims to improve muscle strength and fitness. The exercise and
nutritional intervention group receives the exercise intervention supplemented
by a nutritional intervention ( 3 months exercise program with 15 months
lifestyle counseling, plus nutritional counseling for 15 months). The lifestyle
counseling is based on the theory of behavioral change. Motivational
interviewing techniques are used to improve self-management skills of the
participants .
Study burden and risks
Participation in the study does not imply any health risks. The research
protocol provides strict precautions to ensure patient safety. Prior to
baseline measurements participants will be medically evaluated by a
nephrologist to decide whether the patient is medically able to participate in
the research (eg on the basis of medical history, listen to your heart and
lungs, measurement of blood pressure and possibly an ECG ).If indicated, the
nephrologist will consult the cardiologist. Furthermore, prior to all exercise
testing and training sessions, an extended warm-up will be performed in order
to keep the risk of sport related injuries as small as possible. Maximal
exercise tests will take place under medical supervision and ECG monitoring and
blood pressure will be recorded during the test. The test will be stopped
immediately when changes or abnormalities in the ECG occur , systolic blood
pressure is higher than 250 mmHg , diastolic blood pressure is higher than 120
mmHg or blood pressure will drop more than 20 mmHg. There are detailed
instructions on how to act when problems would occur during the intervention
program.
When (sports ) injuries occur during the intervention , participants will be
referred to their GP. The nephrologist will be informed if any injury will
occur. In case of any cardiac and / or pulmonary problems the nephrologist
.will be contacted.
Hanzeplein 1
Groningen 9700RB
NL
Hanzeplein 1
Groningen 9700RB
NL
Listed location countries
Age
Inclusion criteria
• Age over 18 years;
• Informed Consent;
• < 1 year after transplantation;
• Approval for participation in the study by the nephrologist based on a clinical evaluation
Exclusion criteria
• Psychopathology or severe cognitive impairment
• Combined organ transplantation
• Physical or clinical limitations that prevent participation to the intervention program.
• Negative results of medical screening by the nephrologist or cardiologist.*
• Pregnancy
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
Register | ID |
---|---|
CCMO | NL49084.042.14 |