Table 2 Outcome measures
Characteristics & confounders | Description and instrument | Data source | Sample | Collection points |
|---|---|---|---|---|
Overall | ||||
 Participant’s characteristics | Date of birth, gender, ethnicity, BMI (height, weight), highest academic qualification (no degree, middle school, high school), labor situation (working, retired, unemployed in rehabilitation status), current profession, weight at birth, week of pregnancy at birth | SAQ | IG, CG | t0 |
 Clinical status | Diagnoses of OA, Diabetes mellitus Type 2, Cardio vascular disease, and if applicable, date of initial diagnosis, in case of OA site (s) and joint (s) of OA diagnosis | SAQ, on-site CRF | IG, CG | t0 |
| Â | Other diagnosed comorbidities | SAQ, on-site CRF | IG, CG | t0 |
| Â | Current medication assessed via medication schedule and/or packaging. Also, pre-determined drugs are recorded via the IDB | SAQ IDB On-site CRF | IG, CG | t0, t6, t12 |
 History of exercise participation | Athleticism during childhood and adolescence | SAQ | IG, CG | t0 |
 Outcome expectations | Personal therapy expectations | SAQ | IG, CG | t0 |
Primary Outcome measure | Clinical Outcomes | |||
 Physical activity status | Leisure-time physical activity in a typical week (EHIS-PAQ, HEPA Index [38]) | SAQ | IG, CG | t0, t3, t6, t12, t18 |
Secondary outcome measure | Clinical outcomes | |||
 Physical activity status | Work-related and transport-related physical activity in a typical week (EHIS-PAQ [38]) | SAQ | IG; CG | t0, t3, t6, t12, t18 |
Actigraph (wGT3X-BT Accelerometer) for 7Â days | wGT3X-BT Accelerometer | IG, CG | t0, t6, t12 | |
 Health related quality of life | Veterans RAND 12 Item Health Survey (VR12), retrospective 4 weeks [39, 40] | SAQ | IG, CG | t0, t3, t6, t12, t18 |
 Global health assessment | One Item, General Health, of the VR12 [39, 40] to assess global health [41] | SAQ | IG, CG | t0, t3, t6, t12, t18 |
 Overall perceived benefit | Overall perceived satisfaction with the benefit of the intervention [42] | SAQ | IG, CG | t3, t6, t12, t18 |
 Osteoarthritis specific outcomes | Hip Osteoarthritis Outcome Score (HOOS), Knee injury and Osteoarthritis Outcome Score (KOOS) | SAQ | IG, CG (only participants with OA) | t0, t3, t6, t12, t18 |
SAQ | IG, CG (only participants with OA) | t0, t3, t6, t12, t18 | ||
 Cardio vascular risk status | 10-year risk of myocardial infarction, PROCAM-Score short form [32] | SAQ | IG, CG | t0, t3, t6, t12, t18 |
 Diabetes mellitus risk status | SAQ | IG, CG | t0, t3, t6, t12, t18 | |
 Dietary intake | Food Frequency Questionnaire [44] | SAQ | IG, CG | t0, t3, t6, t12, t18 |
| Â | Physiological Outcomes | |||
 Physical performance measures | Spiroergometry: VO2 max, respiratory ratio, physical working capacity (Aeroscan GmbH) | Aeroman | IG, CG | t0, t6, t12 |
Lower body strength measure: 30Â s sit to stand Test (CST) [42, 45] | 30 CST | IG; CG | t0, t6, t12 | |
Electrocardiogram (ECG) (custo med GmbH) to assess heart rate, systolic and diastolic blood pressure at rest and during exercise test | Custo Cardio 300 | IG; CG | t0, t6, t12 | |
 Body composition | Assessment of body composition (muscle, fat, water distribution) with bioimpedance analysis (SMT medical GmbH & Co.) | BIA101 BIVA | IG, CG | t0, t6, t12 |
 Metabolomics | Capillary blood sample from earlobes on Guthrie cards to assess carnitine, short- and long-chain acylcarnitines, methionine, phenylalanine, tyrosine, valine, leucine, isoleucine, succinylacetone, citrulline | Blood sample | IG, CG | t0, t6, t12 |
 Laboratory data | Fasting blood sample: HbA1c, insulin, fasting glucose, IL-6, CRP, cholesterol, LDL, HDL, triglycerides, miRNAs, adiponectin, leptin, resistin, COMP Urine sample: CTXII | Blood and Urine sample | Sub-sample IG, CG | t0, t6, t12 |
| Â | Exercise psychological outcomes | |||
 Exercise-specific self-efficacy | Multidimensional Self-Efficacy for Exercise Scale: task, coping, and scheduling efficacy [46] | SAQ | IG, CG | t0, t3, t6, t12, t18 |
 Sport and exercise-related self-concordance | Self-concordance of sport- and exercise-related goals: intrinsic, identified, introjected, and extrinsic modes of motivation [47] | SAQ | IG, CG | t0, t3, t6, t12, t18 |
 Physical-activity related health competence | Physical-activity related health competence questionnaire: control of physical load, affect regulation, and self-control [21, 48] | SAQ | IG, CG | t0, t3, t6, t12, t18 |
 Sport- and exercise specific motivational competence | Questionnaire on motivational competence in exercise and sport: knowing one’s own preferences, knowing what to expect in different exercise and sport activities and choosing and arranging an exercise and sport activity [49] | SAQ | IG, CG | t0, t3, t6, t12, t18 |
 Action and coping planning | Exercise planning scales: action plans, coping plans [50] | SAQ | IG, CG | t0, t3, t6, t12, t18 |
 Attitudes towards physical activity | Cognitive and affective attitudes towards physical activity [51] | SAQ | IG, CG | t0, t3, t6, t12, t18 |
 Motives and goals for exercise | Bernese motive and goal inventory [52] | SAQ | IG | Throughout intervention phase 1 (week 7), t6, t12 |
 Fear of movement /(re)injury | Tampa Scale for Kinesiophobia [53] | SAQ | IG, CG | t0, t3, t6, t12, t18 |
| Â | Economic Data | |||
 Unspecific and specific (disease-related) health care costs | Outpatient costs, hospital costs, medication, adjuvants, rehabilitation treatment, medically prescribed supplementary treatments (e.g. hydrotherapy, physiotherapy, massages) | IDB | IG, CG | tm18, tm12, tm6 t6, t12, t18 |
 Unspecific/specific (disease related) periods of disability | Days of disability (overall and related to referred diseases) | IDB | IG, CG | tm18, tm12, tm6 t6, t12, t18 |
 Intervention related costs | Costs for human and physical resources/session | IDB | IG | t6, t18 |
| Â | Process evaluation | |||
 Characteristics of the usual care arm | Questions on utilization of usual care offers | SAQ | CG | t3, t6, t12 |
 Participants’ satisfaction | Modified version of the ZUF-8 Questionnaire to assess participants’ satisfaction with the intervention [54] | SAQ | IG, CG | t3, t6, t12, t18 |
 Participants’ view on the intervention | Qualitative interviews with participants including questions on the appropriateness and quality of the intervention delivery | QI | Sub-sample IG | after last intervention delivery |
 Treatment fidelity | Field notes for intervention progress (Troubleshooting) | Documentation sheets | Research Team | continuously |
| Â | Notes for intervention delivery | Notation sheets | Interventionists | continuously |
 Characteristics of interventionists | Questionnaires on occupational self-efficacy [55], subjective value attributions [56] and implementation outcomes (acceptability, appropriateness, and feasibility of the intervention) [57] | SAQ | Interventionists | t0, t6 |
 Interventionists’ view on the program | Qualitative interviews with exercise specialists regarding acceptability, practicality, appropriateness and fidelity aspects of the intervention delivery | QI | Interventionists | after last intervention delivery |
|  | Satisfaction with the interventionists’ training [58] | SAQ | Interventionists | after interventionists training |
 Evaluation of implementation regarding interfaces of the health service innovation | Practitioners’ view on the acceptability, appropriateness, and feasibility of the program and its prescription [57] | SAQ | Health insurance company (APS) | during recruitment |
| Â | Mode of access to the program | Telephone screening | IG, CG | during recruitment |
 Evaluation of implementation regarding the interface with community-based exercise offers | Qualitative interviews with participants and employees of the health insurance company | QI | Sub-sample IG and interventionists | after last intervention delivery |
 Adherence to exercise training | Summarized number of attended training sessions and reported trainings sessions according to training logs of the exercise specialists and participants (IG) | Training logs, on-site reporting sheet (IG); SAQ, IDB (for CG only) | IG, CG | t3, t6 |
| Â | Safety and Adverse Events | |||
 Adverse events and side-effects | Summarized number and details of adverse events and side-effects according to training log and case report form | Training logs, on-site CRF, SAQ | IG | t3, t6 |
Covariates | ||||
 Depressive and anxiety symptoms | Self-report of depressive symptoms and anxiety symptoms in the last week [59] | SAQ | IG, CG | t0, t3, t6, t12, t18 |
 Osteoporosis risk status | German version of osteoporosis risk test [60] | SAQ | IG, CG | t0, t3, t6, t12, t18 |
 Back pain | Three months retrospective questionnaire on the severity of chronic back pain [61, 62] | SAQ | IG, CG | t0, t3, t6, t12, t18 |