Outcome
Type |
Measure |
Description |
Time frame |
Safety issue |
Primary |
Bone mineral density |
Bone density measured with dual energy x-ray |
pre-surgery |
|
Primary |
Bone mineral density |
Bone density measured with dual energy x-ray |
2 months post-surgery |
|
Primary |
Bone mineral density |
Bone density measured with dual energy x-ray |
6 months post-surgery |
|
Primary |
Bone mineral density |
Bone density measured with dual energy x-ray |
18 months post-surgery |
|
Primary |
Bone structure |
Radius strength and structure measured with peripheral quantitative computed tomography |
pre-surgery |
|
Primary |
Bone structure |
Radius strength and structure measured with peripheral quantitative computed tomography |
2 months post-surgery |
|
Primary |
Bone structure |
Radius strength and structure measured with peripheral quantitative computed tomography |
6 months post-surgery |
|
Primary |
Bone structure |
Radius strength and structure measured with peripheral quantitative computed tomography |
18 months post-surgery |
|
Primary |
Body composition |
Body fat and visceral adipose tissue measured with Dual energy X-ray |
pre-surgery |
|
Primary |
Body composition |
Body fat and visceral adipose tissue measured with Dual energy X-ray |
2 months post-surgery |
|
Primary |
Body composition |
Body fat and visceral adipose tissue measured with Dual energy X-ray |
6 months post-surgery |
|
Primary |
Body composition |
Body fat and visceral adipose tissue measured with Dual energy X-ray |
18 months post-surgery |
|
Primary |
Fecal gut microbiota |
Stool specimens will be taken. Samples will be sequenced by Shallow Shotgun Metagenomic sequencing using Illumina Sequencing PE150 (5 G raw data per sample). |
pre-surgery |
|
Primary |
Fecal gut microbiota |
Stool specimens will be taken. Samples will be sequenced by Shallow Shotgun Metagenomic sequencing using Illumina Sequencing PE150 (5 G raw data per sample). |
6 months post-surgery |
|
Primary |
Fecal gut microbiota |
Stool specimens will be taken. Samples will be sequenced by Shallow Shotgun Metagenomic sequencing using Illumina Sequencing PE150 (5 G raw data per sample). |
18 months post-surgery |
|
Secondary |
Basal metabolic rate |
Basal metabolic rate |
pre-surgery, 2 months post-surgery, 6 months post-surgery and 18 months post-surgery |
|
Secondary |
Heart rate variability |
Heart rate variability measured in fasting and resting conditions |
pre-surgery, 2 months post-surgery, 6 months post-surgery and 18 months post-surgery |
|
Secondary |
Aerobic capacity |
Bruce protocol on a treadmill |
pre-surgery, 2 months post-surgery, 6 months post-surgery and 18 months post-surgery |
|
Secondary |
Muscular strength of the upper limbs |
Measured with a handgrip dynamometer |
pre-surgery, 2 months post-surgery, 6 months post-surgery and 18 months post-surgery |
|
Secondary |
Muscular strength of the lower limbs |
Measured with the stand and sit chair test |
pre-surgery, 2 months post-surgery, 6 months post-surgery and 18 months post-surgery |
|
Secondary |
Agility |
Measured with the time up and go test. Sitting on a chair the participant has to stand up and walk 2,4 meters forward, turn and sit back on the chair. |
pre-surgery, 2 months post-surgery, 6 months post-surgery and 18 months post-surgery |
|
Secondary |
Balance |
Measured with the SPPB battery in three different position (feet together, tandem, semi tandem) |
pre-surgery, 2 months post-surgery, 6 months post-surgery and 18 months post-surgery |
|
Secondary |
Gait kinematics |
Gait kinematics measured with inertial sensors |
pre-surgery, 2 months post-surgery, 6 months post-surgery and 18 months post-surgery |
|
Secondary |
Frailty status |
SPPB measures |
pre-surgery, 2 months post-surgery, 6 months post-surgery and 18 months post-surgery |
|
Secondary |
Quality of life of participants SF36 |
Quality of life measured with the SF36 |
pre-surgery, 2 months post-surgery, 6 months post-surgery and 18 months post-surgery |
|
Secondary |
Quality of life of participants EUROQOL 5Q |
Quality of life measured with the EUROQOL 5Q |
pre-surgery, 2 months post-surgery, 6 months post-surgery and 18 months post-surgery |
|
Secondary |
Pain scale |
Pain measured with the WOMAC questionnaire |
pre-surgery, 2 months post-surgery, 6 months post-surgery and 18 months post-surgery |
|
Secondary |
Objective physical activity levels |
Physical activity levels registered with triaxial accelerometers that they will wear during 7 days. |
pre-surgery, 2 months post-surgery, 6 months post-surgery and 18 months post-surgery |
|
Secondary |
Physical activity levels |
Physical activity levels measures with IPAQ-short |
pre-surgery, 2 months post-surgery, 6 months post-surgery and 18 months post-surgery |
|
Secondary |
Ankle range of motion |
Measurement of dorsiflexion and plantar flexion |
pre-surgery, 2 months post-surgery, 6 months post-surgery and 18 months post-surgery |
|
Secondary |
Inflammatory markers |
Interleukin 6, TNF alpha, and reactive C protein |
pre-surgery, 2 months post-surgery, 6 months post-surgery and 18 months post-surgery |
|
Secondary |
Blood glucose |
Glucose levels |
pre-surgery, 2 months post-surgery, 6 months post-surgery and 18 months post-surgery |
|
Secondary |
Cholesterol |
Blood cholesterol levels (LDL and HDL) |
pre-surgery, 2 months post-surgery, 6 months post-surgery and 18 months post-surgery |
|
Secondary |
Insulin resistance |
HOMA test and insulin levels |
pre-surgery, 2 months post-surgery, 6 months post-surgery and 18 months post-surgery |
|
Secondary |
Kidney markers |
Creatinine levels |
pre-surgery, 2 months post-surgery, 6 months post-surgery and 18 months post-surgery |
|
Secondary |
Liver function (ALT) |
Alanine transaminase levels |
pre-surgery, 2 months post-surgery, 6 months post-surgery and 18 months post-surgery |
|
Secondary |
Liver function (AST) |
Aspartate transaminase |
pre-surgery, 2 months post-surgery, 6 months post-surgery and 18 months post-surgery |
|
Secondary |
Liver function (ALP) |
Alkaline phosphatase |
pre-surgery, 2 months post-surgery, 6 months post-surgery and 18 months post-surgery |
|
Secondary |
Liver function (GGT) |
Gamma-glutamyl transferase |
pre-surgery, 2 months post-surgery, 6 months post-surgery and 18 months post-surgery |
|
Secondary |
Liver function (bilirubin) |
Serum bilirubin levels |
pre-surgery, 2 months post-surgery, 6 months post-surgery and 18 months post-surgery |
|
Secondary |
International normalised ratio test |
INR coagulation |
pre-surgery, 2 months post-surgery, 6 months post-surgery and 18 months post-surgery |
|
Secondary |
Albumin levels |
Serum albumin levels |
pre-surgery, 2 months post-surgery, 6 months post-surgery and 18 months post-surgery |
|
Secondary |
Iron metabolism |
Iron metabolism markers |
pre-surgery, 2 months post-surgery, 6 months post-surgery and 18 months post-surgery |
|
Secondary |
Vitamin B12 levels |
Plasma vitamin B12 levels |
pre-surgery, 2 months post-surgery, 6 months post-surgery and 18 months post-surgery |
|
Secondary |
Folic acid levels |
Plasma folic acid levels |
pre-surgery, 2 months post-surgery, 6 months post-surgery and 18 months post-surgery |
|
Secondary |
Hydroxyvitamin D |
Plasma Hydroxyvitamin D levels |
pre-surgery, 2 months post-surgery, 6 months post-surgery and 18 months post-surgery |
|
Secondary |
Calcium |
Plasma calcium levels |
pre-surgery, 2 months post-surgery, 6 months post-surgery and 18 months post-surgery |
|
Secondary |
Phosphorus |
Plasma phosphorus levels |
pre-surgery, 2 months post-surgery, 6 months post-surgery and 18 months post-surgery |
|
Secondary |
Parathyroid hormone |
Parathyroid hormone plasma levels |
pre-surgery, 2 months post-surgery, 6 months post-surgery and 18 months post-surgery |
|
Secondary |
Bone alkaline phosphatase |
Bone alkaline phosphatase plasma levels |
pre-surgery, 2 months post-surgery, 6 months post-surgery and 18 months post-surgery |
|
Secondary |
Leptin |
Leptin plasma levels |
pre-surgery, 2 months post-surgery, 6 months post-surgery and 18 months post-surgery |
|
Secondary |
Adinopectin |
Adinopectin plasma levels |
pre-surgery, 2 months post-surgery, 6 months post-surgery and 18 months post-surgery |
|
Secondary |
Diet |
Diet will be assessed though a food frequency questionnaire |
pre-surgery, 6 months post-surgery |
|
Secondary |
Depression, anxiety and stress questionnaire |
Dass 21 scale |
pre-surgery, 2 months post-surgery, 6 months post-surgery and 18 months post-surgery |
|