Outcome
| Type |
Measure |
Description |
Time frame |
Safety issue |
| Other |
Isometric knee-extension strength |
Isometric knee-extension strength assessed using a hand-held dynamometer. Assessed at baseline, 4 and 12 months. |
Primary endpoint: Change from baseline to 12 months |
|
| Other |
Balance |
Tandem 30-second balance test. Assessing balance in 30-second with 10 seconds in each of the 3 different positions (parallel feet, semi-tandem and tandem stand) resulting in a score from 0-30, higher is better. Assessed at baseline, 4 and 12 months. |
Primary endpoint: Change from baseline to 12 months |
|
| Other |
Pain (yes/no) in left and right knee and hip + worst joint if more than one |
Left/right knee/hip pain + worst joint if more than one. Assessed at baseline, 4, 6 and 12 months. |
Primary endpoint: Change from baseline to 12 months |
|
| Other |
Stress |
Perceived Stress Scale (4-item version). Ranging from 0-16, higher is more stressed. Assessed at baseline, 4, 6 and 12 months. |
Primary endpoint: Change from baseline to 12 months |
|
| Other |
Systolic and diastolic blood pressure |
Blood pressure after 5 minutes of rest. Assessed at baseline, 4 and 12 months. |
Primary endpoint: Change from baseline to 12 months |
|
| Other |
Concentration of cholesterol (HDL and LDL) and triglyceride |
Levels of cholesterol (HDL and LDL) and triglyceride. Assessed at baseline and 4 months. |
Primary endpoint: Change from baseline to 4 months |
|
| Other |
Concentration of Fasting glucose |
Levels of fasting glucose. Assessed at baseline and 4 months. |
Primary endpoint: Change from baseline to 4 months |
|
| Other |
Concentration of Fasting insulin |
Levels of fasting insulin. Assessed at baseline and 4 months. |
Primary endpoint: Change from baseline to 4 months |
|
| Other |
Concentration of HbA1c |
Levels of HbA1c. Assessed at baseline and 4 months. |
Primary endpoint: Change from baseline to 4 months |
|
| Other |
Concentration of high-sensitivity C-reactive protein (hs-CRP) |
Levels of the inflammatory marker high-sensitivity C-reactive protein (hs-CRP). Assessed at baseline and 4 months. |
Primary endpoint: Change from baseline to 4 months |
|
| Other |
Concentration of Tumor necrosis factor (TNF) |
Levels of the inflammatory marker Tumor necrosis factor (TNF). Assessed at baseline and 4 months. |
Primary endpoint: Change from baseline to 4 months |
|
| Other |
Concentration of Interleukin 6 (IL-6) |
Levels of the inflammatory marker Interleukin 6 (IL-6). Assessed at baseline and 4 months. |
Primary endpoint: Change from baseline to 4 months |
|
| Other |
Concentration of Interleukin-1 receptor antagonist (IL-1ra) |
Levels of the inflammatory marker Interleukin-1 receptor antagonist (IL-1ra). Assessed at baseline and 4 months. |
Primary endpoint: Change from baseline to 4 months |
|
| Other |
Weight |
Weight in kg. measured with a scale. Assessed at baseline, 4 and 12 months. |
Primary endpoint: Change from baseline to 12 months |
|
| Other |
Adapted Fried Frailty and pre-frailty criteria |
Frailty and pre-frailty assessed by the Adapted Fried Frailty and pre-frailty criteria. Assessed at baseline, 4 and 12 months. |
Primary endpoint: Change from baseline to 12 months |
|
| Other |
Fatigue |
One-item self-reported fatigue. Assessed at baseline, 4, 6 and 12 months. |
Primary endpoint: Change from baseline to 12 months |
|
| Other |
Disease-specific treatment |
Self-reported disease-specific treatment. Assessed at baseline, 4, 6 and 12 months. |
Primary endpoint: Change from baseline to 12 months |
|
| Other |
Knee/hip pain, VAS |
Average knee/hip pain during the last 7 days on a 0-100 visual analogue scale for worst joint (higher is worse pain, only for patients reporting knee/hip pain). Assessed at baseline, 4, 6 and 12 months. |
Primary endpoint: Change from baseline to 12 months |
|
| Other |
Patient Acceptable Symptom State (PASS) |
"Thinking about your quality of life, would you consider your current health as satisfying? With quality of life, you should consider your activities of daily living, sport and recreational activities, personal care, level of pain, and any anxiety or depression." Answered by "yes" or "no". Assessed at 4, 6 and 12 months. |
Primary endpoint: 12 months |
|
| Other |
Patient-reported treatment failure |
Only answered by patients answering "no" to PASS. "Would you consider your current state as being so unsatisfactory that you consider the treatment to have failed?". Answered by "yes" or "no". Assessed at 4 and 12 months. |
Primary endpoint: 12 months. |
|
| Other |
Adherence |
Adherence to intervention protocol of the study assessed as the number of exercise and self-management support sessions attended out of the total number of sessions available. Assessed at 4 months. |
Primary endpoint: 4 months |
|
| Other |
Other treatment during follow-up |
Assessed by asking the patient about changes in their pharmacological treatment as well as any other treatments that they have received outside the study since the last assessment. If the patient answers yes, questions on details of the changes and other treatments will be asked. Assessed at 4, 6 and 12 months. |
Primary endpoint: 12 months |
|
| Other |
Work status |
"What is your current work status?" The patients choose one of several categories (e.g. "Working", "On sick leave, full time" and "Pensioner". Assessed at baseline, 4, 6 and 12 months. |
12 months. |
|
| Other |
Smoking |
"How many cigarettes did you smoke in the last 7 days?" Assessed at baseline, 4, 6 and 12 months. |
Primary endpoint: 12 months |
|
| Other |
Questionnaire burden (only feasibility study) |
"Did you find the questionnaire so burdensome that you would not participate in the study again?" Answered "yes"/"no". Assessed at baseline and 4 months. |
Primary endpoint: 4 months |
|
| Other |
Assessment burden (only feasibility study) |
"Did you find the assessments so burdensome that you would not participate in the study again?" Answered "yes"/"no". Assessed at baseline and 4 months. |
Primary endpoint: 4 months |
|
| Other |
Isometric handgrip strength |
Isometric handgrip strength assessed using a hand-held dynamometer. Assessed at baseline, 4 and 12 months. |
Primary endpoint: Change from baseline to 12 months |
|
| Other |
Multimorbidity Treatment Burden |
Multimorbidity Treatment Burden Questionnaire. Ranging from 0-100, higher is worse. Assessed at baseline, 4, 6 and 12 months. |
Primary endpoint: Change from baseline to 12 months |
|
| Other |
Short form of Patient Activation Measure (PAM) |
Short form of Patient Activation Measure (PAM). Ranging from 0-100, higher scores indicating higher levels of patient activation. Assessed at baseline, 4, 6 and 12 months. |
Primary endpoint: Change from baseline to 12 months |
|
| Other |
Bodily pain |
The number of self-reported body sites with pain in the previous 24 hours reported on a region-divided body chart of the front (A) and back (B) sides of the body. Assessed at baseline, 4, 6 and 12 months. |
Primary endpoint: Change from baseline to 12 months |
|
| Other |
Sedentary behaviour |
Daily sedentary behaviour (one item). Assessed at baseline, 4, 6 and 12 months. |
Primary endpoint: Change from baseline to 12 months |
|
| Other |
Individual items from the 12-item WHODAS 2.0 |
The 12 individual items from WHO Disability Assessment Schedule 2.0. Ranging from 1 to 5, higher score is worse. Assessed at baseline, 4, 6 and 12 months. |
Primary endpoint: Change from baseline to 12 months |
|
| Other |
Spirometry (FEV1) |
Spirometry (MedikroPro) will be used to measure forced expiratory volume in first second in liter (FEV1).Assessed at baseline. |
Only assessed at baseline. |
|
| Other |
Self-reported physical activity level |
Weekly physical activity (two items). Assessed at baseline, 4, 6 and 12 months. |
Primary endpoint: Change from baseline to 12 months |
|
| Other |
Global Perceived Effect (GPE) |
Global Perceived Effect (GPE) for physical activity level, activities of daily living and quality of life. Answered on 7-point Likert scale ranging from (1) "Much better, an important improvement" to (7) "Much worse, an important deterioration", higher score is worse. Assessed at 4, 6 and 12 months. |
Primary endpoint: 12 months |
|
| Other |
Falls |
Over the last 4 months, have you ever been falling? "2months" at 6-month follow-up and "6 months" at the 12-month follow-up. (A fall is defined as an event resulting in you inadvertently coming to rest on the ground or another lower level, with or without loss of consciousness or injury). Never; Once; Twice; Three times or more. Assessed at 4, 6 and 12 months. |
Primary endpoint: 12 months |
|
| Other |
Fear of falling |
How concerned are you that you might fall? Not at all concerned; Somewhat concerned, Fairly concerned, Very concerned. Assessed at 4, 6 and 12 months. |
Primary endpoint: 12 months |
|
| Other |
Sedentary activity: Time spent on sedentary activities |
Objectively measured physical activity assessed using combined wearable thigh and wrist accelerometers. Assessed at baseline, 4 and 12 months. |
Primary endpoint: Change from baseline to 12 months |
|
| Other |
Light physical activity: Time spent on light intensity activities |
Objectively measured physical activity assessed using combined wearable thigh and wrist accelerometers. Assessed at baseline, 4 and 12 months. |
Primary endpoint: Change from baseline to 12 months |
|
| Other |
Moderate physical activity: Time spent on moderate intensity activities |
Objectively measured physical activity assessed using combined wearable thigh and wrist accelerometers. Assessed at baseline, 4 and 12 months. |
Primary endpoint: Change from baseline to 12 months |
|
| Other |
Vigorous physical activity: Time spent on vigorous intensity activities |
Objectively measured physical activity assessed using combined wearable thigh and wrist accelerometers. Assessed at baseline, 4 and 12 months. |
Primary endpoint: Change from baseline to 12 months |
|
| Other |
Moderate to vigorous physical activity: Time spent on moderate to vigorous intensity activities |
Objectively measured physical activity assessed using combined wearable thigh and wrist accelerometers. Assessed at baseline, 4 and 12 months. |
Primary endpoint: Change from baseline to 12 months |
|
| Other |
Adherence to the World Health Organization (WHO) physical activity recommendations, i.e. =150 min. MVPA or =75 min. VPA weekly activities |
Objectively measured physical activity assessed using combined wearable thigh and wrist accelerometers. Assessed at baseline, 4 and 12 months. |
Primary endpoint: Change from baseline to 12 months |
|
| Other |
Sleep, objectively measured |
Objectively measured sleep assessed using combined wearable thigh and wrist accelerometers. Assessed at baseline, 4 and 12 months. |
Primary endpoint: Change from baseline to 12 months |
|
| Other |
Sleep quantity, self-reported |
Self-reported average sleep quantity. Assessed at baseline, 4, 6 and 12 months. |
Primary endpoint: Change from baseline to 12 months |
|
| Other |
Modified Karolinska Sleep Questionnaire |
Sleep quality will be measured by the Modified Karolinska Sleep Questionnaire (4 items). Ranging from 4 to 24, lower is worse sleep quality. Assessed at baseline, 4, 6 and 12 months. |
Primary endpoint: Change from baseline to 12 months |
|
| Other |
Vigorous Intermittent Lifestyle Physical Activity (VILPA): Time spent on VILPA intensity activities |
Objectively measured physical activity assessed using combined wearable thigh and wrist accelerometers. Assessed at baseline, 4 and 12 months. |
Primary endpoint: Change from baseline to 12 months |
|
| Primary |
EQ-5D-5L, the descriptive index |
The descriptive index of the EuroQol-5 Domain 5-level questionnaire (EQ-5D-5L) measures the patient's self-rated health status. Ranging from -0.624 to 1, higher is better. This will also allow for a later cost-effectiveness analysis. Assessed at baseline, 4, 6 and 12 months. All visits (baseline, 4, 6 and 12 months) will be included in the analysis. |
Primary endpoint: Change from baseline to 12 months |
|
| Secondary |
6-minute walk test |
The walking distance covered over a time of 6 minutes. Assessed at baseline, 4 and 12 months. |
Primary endpoint: Change from baseline to 12 months |
|
| Secondary |
Burden of illness measure |
The burden of illness measure developed by Bayliss et al. measures how much illness affects the individual's daily activities (on a 1-5 scale for each individual condition, higher is worse, summed to a total score for all conditions, with an upper limit depending on the number of conditions included). Assessed at baseline, 4, 6 and 12 months. |
Primary endpoint: Change from baseline to 12 months |
|
| Secondary |
30-second chair-stand test |
The number of chair stands completed in 30 seconds. Assessed at baseline, 4 and 12 months. |
Primary endpoint: Change from baseline to 12 months |
|
| Secondary |
Depression Scale |
Personal Health Questionnaire Depression Scale (PHQ-8). Ranging from 0-24 points, higher is more severe depression. Assessed at baseline, 4, 6 and 12 months. |
Primary endpoint: Change from baseline to 12 months |
|
| Secondary |
Anxiety |
General Anxiety Disorder-7 (GAD-7). Ranging from 0-21, higher is more severe anxiety. Assessed at baseline, 4, 6 and 12 months. |
Primary endpoint: Change from baseline to 12 months |
|
| Secondary |
Self-Efficacy |
Self-Efficacy for Managing Chronic Disease 6-item Scale. Mean of 6 items, ranging from 1 to 10, higher scores indicating higher self-efficacy. Assessed at baseline, 4, 6 and 12 months. |
Primary endpoint: Change from baseline to 12 months |
|
| Secondary |
Overall functioning and disability |
12-item WHO Disability Assessment Schedule 2.0 (WHODAS 2.0). Ranging from 0 (no disability) to 100 (full disability). Assessed at baseline, 4, 6 and 12 months. |
Primary endpoint: Change from baseline to 12 months |
|
| Secondary |
Adverse events |
Adverse events (AE) and serious adverse events (SAE) will be recorded at all follow-ups by asking the participants about potential AEs using open-probe questioning to ensure that all AEs are recorded. Furthermore, the medical records of the patients will be checked at the primary endpoint (12 months) for all AEs occurring from inclusion until the 12 months follow-up. AEs will be classified according to the Food and Drug Administration definition of an SAE and recorded, categorized and assessed for severity independent of whether or not there is a causal relationship with study treatments. Assessed at 4, 6 and 12 months. |
Primary endpoint: 12 months |
|
| Secondary |
Steps per day |
Objectively measured physical activity assessed using combined wearable thigh and wrist accelerometers. Assessed at baseline, 4 and 12 months. |
Primary endpoint: Change from baseline to 12 months |
|
| Secondary |
Minutes/day spent being physically active with at least light intensity |
Objectively measured physical activity assessed using combined wearable thigh and wrist accelerometers. Assessed at baseline, 4 and 12 months. |
Primary endpoint: Change from baseline to 12 months |
|
| Secondary |
EQ-5D-5L, the subscale EQ VAS |
The EQ visual analogue scale (EQ VAS) evaluates the patient's self-rated health on a 0-100 vertical visual analogue scale, higher score is better. Assessed at baseline, 4, 6 and 12 months. |
Primary endpoint: Change from baseline to 12 months |
|
| Secondary |
Mortality |
Mortality will be recorded at 12 months via medical records |
Primary endpoint: 12 months |
|
