Open: OPTImizing CArdiac REhabilitation by REfining Sleep and STress (OPTICARE-RESST)

Trial Status Open
Overall study start date 24-08-2028
Overall study end date
Country The Netherlands
Trial Number NCT06505109
Trial URL https://clinicaltrials.gov/study/NCT06505109
Summary The primary objective of this project is to investigate the effectiveness and costs of integrating a behavioural program targeting sleep and stress (the RESST intervention) into cardiac rehabilitation (CR). In addition, the investigators will also study whether parameters regarding diversity (e.g., sex, ethnicity, socioeconomic position) are associated with intervention effectiveness. Furthermore, the investigators aim to explore the (bidirectional) relation between sleep and stress on the one hand, and other lifestyle components and health outcomes on the other hand.
Study Design Randomized controlled trial
Study Setting(s)
Study Acronym
Study Hypotheses Adding a behavioural intervention will improve sleep and perceived stress (primary outcomes), along with positive outcomes on biomarkers of chronic stress, QoL, cardiometabolic risk factors, physical fitness, lifestyle components, and psychosocial well-being.
Condition (Cardio)vascular disease
Intervention Subjects randomized to the RESST intervention will receive on top of standard rehabilitation a behavioural group intervention focussing on improving sleep and stress. This intervention will consist of 5 till 6 meetings of 90 till 120 minutes in the local rehabilitation centre during a time period of 3 till 4 months.
Primary Outcome Measure Information regarding sleep and stress
Secondary Outcome Measure Cortisol level Cortisone level Weight Height Body Mass Index (BMI) Blood pressure Smoking behaviour Smoking behaviour Muscle strength Physical activity Sedentary behaviour Alcohol use Health related quality of life Health related quality of life Fatigue Daytime sleepiness Anxiety and depression Participation in society Estimated Cardiorespiratory fitness Presence of restless leg syndrome Presence of insomnia The risk of the presence of obstructive sleep apnoea Costs incurred by the patients Productivity costs Perceived sleep Diet Momentary fatigue Momentary stress Adherence to the CR treatment and RESST intervention Treatment Satisfaction Sex Age Cardiac diagnosis Educational level Relational status Cardiac risk factors Cardiac history Medication usage Comorbidity Socioeconomic status Origin Employment Drug use Current/previous sleep disorder treatment

Eligibility

Participant Type(s) (Cardio)vascular disease
Age Group Adult (18-64), Senior (65+)
Sex Both
Target Number of Participants 200
Total Final Enrolment
Participant Inclusion Criteria - Age at or above 18 years - Proficient in the Dutch language - Experiencing sleep and/or stress problems as indicated by a high score on the Pittsburgh Sleep Quality Index (PSQI score >5) or Perceived Stress Scale-10 (PSS-10 score >13) - Signed informed consent
Participant Exclusion Criteria - Severe psychiatric, cognitive or physical comorbidity that would impede CR participation - Active treatment for sleep disorders, stress, or other forms of (behavioural) therapy at the start of the study or expected to start within the first 6 months of the study, that could interfere with the RESST intervention. Note: Participants with previously diagnosed sleep disorders are eligible if they still experience sleep or stress problems, unless they fall under the above criteria. Participants who received a prior treatment that is still ongoing but has resulted in a stable sleep and stress condition in the 3 months before the cardiovascular event (e.g., Continuous Positive Airway Pressure (CPAP)) are eligible.

Closed: Test-Retest reliability of the FitMáx© questionnaire

Trial Status Closed
Overall study start date 11-10-2033
Overall study end date
Country The Netherlands
Trial Number NL-OMON23304
Trial URL https://onderzoekmetmensen.nl/en/trial/23304
Summary The aim of this trial is to develop and validate a questionnaire as a clinical assessment tool for cardiorespiratory fitness (CRF) in several patient groups. The questionnaire we developed consists of three questions about the maximum capacity for walking/running, cycling and stairclimbing. These are recognisable activities for the general Dutch population. All patients and healthy subjects who are scheduled for a cardiopumonary exercise test (CPET) in the Máxima Medical center are approached for participation in this trial. After receiving signed informed consent and completed questionnaire, the data from the CPET are retrospectively obtained from the electronic patients files. The results of the questionnaire will be compared with the resultst of the cardiopulmonary exercise test in the same patients. Based on the scores of the questionnaire together with simple demographic characteristics a model will be developed to calculate the maximum oxygen uptake (expressed as VO2peak). Moreover we will conduct analyses to determine whether the FitMáx© is able to estimate preoperative risk for complications during or after surgery. Therefore we will determine cut-off points for VO2peak. In the same research population existing and validated physical activity questionnaires are used to compare resultst of the FitMáx© questionnaire with. These questionnaires are; the veterans specific activity questionnaire (VSAQ), the duke activity status index (DASI), the physical fitness questions of the EORTC-QLQ C30 and a Metabolic Equivalent of a Task (MET) questionnaire used for preoperative screening in the Netherlands (validation of the preoperative questionnaire was not found in literature).
Study Design
Study Setting(s)
Study Acronym
Study Hypotheses It is hypothesized that the FitMáx© is reliable in repeated measures, and therefore we expect similar scores when FitMáx© is applied within two weeks.
Condition Healthy, Cardiac, Pulmonary, Oncology
Intervention Is the FitMáx© reliable in repeated measures when applied 2 times within two weeks?
Primary Outcome Measure Is the FitMáx© questionnaire a valid instrument to measure cardiorespiratory fitness expressed as VO2-max?
Secondary Outcome Measure Is the FitMáx© questionnaire a more reliable instrument to estimate physical fitness compared to existing/validated international questionnaires?

Eligibility

Participant Type(s) Healthy, Cardiac, Pulmonary, Oncology
Age Group Adult (18-64), Senior (65+)
Sex Both
Target Number of Participants 140
Total Final Enrolment 140
Participant Inclusion Criteria Patients who are treated in the Máxima Medical Centre (department of cardiology, pulmonology and sports medicine) - Patients or subjects who are aged >18 years - Good command of the Dutch language - No expected change in physical fitness within two weeks from enrollment date
Participant Exclusion Criteria Patients who are treated in another department of the Máxima Medical Centre (apart from the above mentioned departments) - Patients aged

Closed: Development of a clinical assessment tool to estimate cardiorespiratory fitness (preoperatively)

Trial Status Closed
Overall study start date 11-10-2033
Overall study end date
Country The Netherlands
Trial Number NL-OMON23304
Trial URL https://onderzoekmetmensen.nl/en/trial/23304
Summary The aim of this trial is to develop and validate a questionnaire as a clinical assessment tool for cardiorespiratory fitness (CRF) in several patient groups. The questionnaire we developed consists of three questions about the maximum capacity for walking/running, cycling and stairclimbing. These are recognisable activities for the general Dutch population. All patients and healthy subjects who are scheduled for a cardiopumonary exercise test (CPET) in the Máxima Medical center are approached for participation in this trial. After receiving signed informed consent and completed questionnaire, the data from the CPET are retrospectively obtained from the electronic patients files. The results of the questionnaire will be compared with the resultst of the cardiopulmonary exercise test in the same patients. Based on the scores of the questionnaire together with simple demographic characteristics a model will be developed to calculate the maximum oxygen uptake (expressed as VO2peak). Moreover we will conduct analyses to determine whether the FitMáx© is able to estimate preoperative risk for complications during or after surgery. Therefore we will determine cut-off points for VO2peak. In the same research population existing and validated physical activity questionnaires are used to compare resultst of the FitMáx© questionnaire with. These questionnaires are; the veterans specific activity questionnaire (VSAQ), the duke activity status index (DASI), the physical fitness questions of the EORTC-QLQ C30 and a Metabolic Equivalent of a Task (MET) questionnaire used for preoperative screening in the Netherlands (validation of the preoperative questionnaire was not found in literature).
Study Design The scores of the FitMáx©, VASQ, DASI, EORTC-QLQ C30 and preoperative MET questionnaire are collected within 42 days from the cardiopulmonary exercise test.
Study Setting(s) Hospital
Study Acronym Validation of the FitMáx© questionnaire
Study Hypotheses FitMáx© questionnaire is a valid clinical assessment tool for CRF compared to the gold standard, a cardiopulmonary exercise test. Moreover we believe the FitMáx© to be fairly accurate in the preoperative risk.
Condition Healthy, Cardiac, Pulmonary, Oncology, (Cardio)vascular disease
Intervention No interventions are used in this study. Patient data which is used is collected in the context of standard clinical care.
Primary Outcome Measure Is the FitMáx© questionnaire a valid instrument to measure cardiorespiratory fitness expressed as VO2-max?
Secondary Outcome Measure Is the FitMáx© questionnaire a more valid instrument to measure cardiorespiratory fitness compared to existing/validated international questionnaires? - Is the FitMáx© questionnaire without the maximum cycling capacity, still a valid instrument to measure physical fitness? (cultural adaptation for international use) - Is the FitMáx© able to estimate preoperative risk for complications during or after surgery?

Eligibility

Participant Type(s) Healthy, Cardiac, Pulmonary, Oncology, (Cardio)vascular disease
Age Group
Sex Both
Target Number of Participants 800
Total Final Enrolment 361
Participant Inclusion Criteria Patients and healthy subjects who perform a cardiopulmonary exercise test in Máxima Medical Center - Signed informed consent is received
Participant Exclusion Criteria Patients younger than 18 years - Submaximal exercise test due to early abortion of the test - Incomplete questionnaire

Closed: The numbers tell the tale: the validation of an assessment battery for health-related physical fitness in patients with inflammatory bowel disease.

Trial Status Closed
Overall study start date 17-08-2022
Overall study end date 18-07-2022
Country The Netherlands
Trial Number NL-OMON51526
Trial URL https://onderzoekmetmensen.nl/en/trial/51526
Summary Existing literature reports an impaired health-related physical fitness (HRPF) (i.e., body composition, aerobic capacity, muscular strength, muscular endurance, and flexibility) in patients with inflammatory bowel disease (IBD). However, previous studies did not assess HRPF with the 5-component multidimensional concept. HRPF is not routinely screened for and measured within the IBD population in clinical practice. The lack of a simple screening tool and assessment method for HRPF validated for the IBD population hinders the ability to distinguish patients with IBD with adequate physical fitness from those who might benefit from physical exercise interventions targeting specific components. Gold standard measures are too expensive and too complex to implement in daily practice and therefore a screening tool and a simpler assessment battery for HRPF validated in patients with IBD are needed. It is necessary to obtain more objective insights into the specific components of HRPF affected in patients with IBD, and its association with patient-, disease-, and treatment-related factors in order to implement systematic screening in routine care and subsequently offer tailored physical exercise interventions.
Study Design Non-randomized controlled trial
Study Setting(s)
Study Acronym Health-related physical fitness in patients with IBD.
Study Hypotheses
Condition Inflammatory Bowel Disease
Intervention The study involves two study visits for the first 50 patients with IBD and only one study visit for the subsequent 50 patients with IBD and the 100 healthy volunteers. During the first study visit, all participants (n=200) will perform the tests of the assessment battery for HRPF and complete several (digital) questionnaires. Furthermore, healthy volunteers will perform the Biodex dynamometry since normative values are lacking. Based on the validation analyses, as no alternative brief fitness measurement was found for muscular endurance, patients with IBD who will undergo only one study visit will also perform Biodex dynamometry of the Biodex dynamometry on the (first) study visit. During the second study visit, a representative subgroup (n=50) of patients with IBD will undergo the gold standard measurements for HRPF. No important health risks are considered since the risk of an adverse event during exercise testing is rare. Moreover, patients will be screened for contraindications for maximal exercise testing based on the Physical Activity Readiness Questionnaire (PAR-Q) prior to participation. By participating in this study, participants gain insight into the degree of their HRPF.
Primary Outcome Measure The main study parameters are the results of the screening tools (Duke Activity Status Index, Modified Duke Activity Status Index, Veterans-Specific Activity Questionnaire, Fitmax Questionnaire), of the tests of the assessment battery (skinfold thickness, bioelectrical impedance analysis, upper arm and waist circumference, steep ramp test, handgrip strength and endurance, handheld dynamometry of the leg extensor and flexor muscles, 1-minute sit-to-stand test, and sit-and-reach test), and of the gold standard measures for HRPF (deuterium oxide dilution, maximal cardiopulmonary exercise testing, and Biodex dynamometry of the leg extensor and flexor muscles).
Secondary Outcome Measure Secondary endpoints include:
  • Subjective physical activity expressed in estimated metabolic equivalents (MET) min/week derived from the International Physical Activity Questionnaire - Short Form (IPAQ-SF)
  • Total physical activity measured with the MOX accelerometer;
  • Fatigue scores according to the Checklist Individual Strength (CIS)
  • Patient perspectives on physical fitness, on the relationship between physical fitness and IBD-related complaints, and their willingness to improve physical fitness according to the Lichamelijke Fitheid Vragenlijst
Other study parameters include:
  • Patient characteristics: age, gender, comorbidities, socio-economic status, IBD-subtype, clinical features of IBD (e.g., disease activity scores [according to fecal calprotectin, PGA, MIAH, CDAI, HBI, or SCCAI], Montreal classification, disease duration, complications, extra-intestinal manifestations), (IBD-related) surgical history, (IBD-related) hospitalization, medication use, smoking status;
  • Other relevant patient-reported information collected for usual care in myIBDcoach, including: disease control according to the IBD-control questionnaire, quality of life according to the ED-5Q-5L questionnaire, infections, exercise norm, risk of malnutrition according to the SNAQ, stress and life events, anxiety according to the GAD-7 questionnaire, and depression according to the PHQ-9 questionnaire (30).

Eligibility

Participant Type(s) Inflammatory Bowel Disease
Age Group Adult (18-64), Senior (65+)
Sex Both
Target Number of Participants 200
Total Final Enrolment 200
Participant Inclusion Criteria Inclusion criteria for all participants:
  • Any gender aged 18 years or older;
  • American Society of Anesthesiologists (ASA) Physical Status I or II (i.e., normal healthy patient or a patient with mild systemic disease);
  • No contraindications for exercise testing (based on the Physical Activity Readiness Questionnaire);
  • Being able to provide written informed consent;
  • Willing and being able to complete questionnaires and perform performance tests;
  • Being able to understand written Dutch and speak the Dutch language.
Inclusion criteria specific for patients with IBD:
  • Certified diagnosis of IBD (UC or CD) based on the combination of endoscopic, radiological, and/or histological findings;
  • No clinical active disease or experiencing mild to moderate clinical disease activity (Harvey-Bradshaw Index [HBI] = 16 for CD and Simple Clinical Colitis Activity Index [SCCAI] = 11 for UC);
  • Included in eHealth clinical care-pathway using myIBDcoach.
Inclusion criteria specific for control subjects:
  • No certified diagnosis of IBD (CD, UC, or IBD-Unclassified).
Participant Exclusion Criteria Exclusion criteria for all participants:
  • ASA Physical Status > II (i.e., patient with severe systemic disease);
  • Contraindications for exercise testing based on the Physical Activity Readiness Questionnaire; If a person answers yes to one or more questions, a medical doctor will be consulted to see whether the person should participate or be excluded on safety grounds;
  • Other (temporary) injuries or severe (neuro)muscular, rheumatic, or orthopedic conditions that may interfere with study evaluations;
  • Current malignancy (except for local cutaneous cancer) or successfully treated for a malignancy in the past 6 months;
  • Pregnant or lactating women;
  • Competitive and elite athletes (i.e., >=6 hours/week of moderate to vigorous exercise);
  • Not being able to cooperate with test procedures or unable to provide informed consent;
  • Not being able to understand or speak the Dutch language.

Pending: Are muscle characteristics associated with the effect of exercise training on muscle strength in rheumatic diseases and sarcopenia? - an explorative study: The Care for Muscle (C4M) Study

Trial Status Pending
Overall study start date
Overall study end date
Country The Netherlands
Trial Number NL86908.018.24
Trial URL https://onderzoekmetmensen.nl/en/trial/57399
Summary C4M hypothesizes that patients with low muscle strength may respond differently to different types of exercise intervention, dependent on the underlying aetiology, i.e. impaired protein synthesis versus metabolic dysfunction. This response is related to various clinical, blood-based, and muscle metabolic and architectural biomarkers and the clinical diagnosis, i.e., rheumatoid arthritis (RA), osteoarthritis (OA), and sarcopenia alone (SARC). Understanding the underlying biochemical muscle characteristics of each diagnosis group can help to develop more targeted training in making it more effective.
Study Design two-arm parallel-group exploratory trial including a total of 69 patients
Study Setting(s) Hospital
Study Acronym C4M
Study Hypotheses patients with low muscle strength may respond differently to different types of exercise intervention, dependent on the underlying aetiology, i.e. impaired protein synthesis versus metabolic dysfunction.
Condition Rheumatoid arthritis
Intervention Exercise intervention 2 times a week for 8 weeks on location and once a week at home.
Primary Outcome Measure The primary study parameter is the difference in isokinetic muscle strength pre- and post-intervention in all three patient groups. Quadriceps strength (isokinetic, BIODEX).
Secondary Outcome Measure

A set of biomarkers obtained by muscle biopsy and blood that characterize muscle quality in terms of energy management, histology (architecture), gene expression and inflammation.

  • Feasibility: therapy adherence, drop-out rate, user satisfaction, Net Promoter score (Reichheld 2003)
  • Subject characteristics: age, gender, height, weight, comorbidity (CIRS), medication, educational level, employment, marital status, smoking and alcohol use, duration symptoms, use of walking devices
  • Anthropometrics: BMI, absolute & relative muscle mass (Bio Impedance Analysis). Short-form mini-nutritional assessment (MNA-SF, Rubenstein 2001).
  • Disease characteristics: diagnosis, radiologic severity RA/OA
  • Performance: Muscle endurance (Biodex), Handgrip strength (JAMAR), Short Physical Performance Battery (SPPB), Six Minute Walking Test (6MWT), FITMAX survey (Meijer 2021), PROMIS short form-CAT pain, fatigue, physical function, social function.
  • Muscle architecture (by ultrasound): Volume, CSA, muscle pennation angle, fascicle length.

Eligibility

Participant Type(s) Rheumatoid arthritis
Age Group Adolescent / Teen (12-17 years), Adult (18-64)
Sex Both
Target Number of Participants 69
Total Final Enrolment
Participant Inclusion Criteria For all patients: Willingness and motivation to exercise. Low muscle strength defined as hand grip strength (HGS) 27 kg and 15 sec (Cruz Jentoft 2019). - Gait speed of >0.8m/s to exclude patients who are too disabled to participate in the study (Cruz Jentoft 2019). Osteoarthritis patients - Ages between 50 and 70 - Patients with either knee and/or hip osteoarthritis according to clinical American College of Rheumatology criteria (Altman 1986). - Kellgren and Lawrence (K&L) grading score of 2-4 for hip and/or knee OA. - C-reactive Protein (CRP) levels 10mg/L within 3 months prior to enrolment Rheumatoid arthritis patients - Ages between 50 and 70 - Diagnosed with RA according to EULAR/ ACR criteria (Aletaha 2010). - Disease activity score (DAS28) 2.81 year and Sarcopenia patients - Ages between 50 and 80. - Sarcopenia without joint involvement (no OA, RA), according to the EWGSOPII criteria (Cruz Jentoft 2019) of low muscle strength defined as hand grip strength (HGS) d sarcopenia (appendicular muscle Lean Mass (ALM)/height2 s no selection criterion. Severe sarcopenia will be excluded (gait speed nt disease).
Participant Exclusion Criteria BMI 35 Kg/m2 Contra-indications for exercise testing and prescription are on the basis of theanswers from the *physical activity readiness questionnaire* (PAR-Q) and familiarity(by self-report) of the following heart conditions: heart failure symptoms, myocardialinfarction less than three months before the start of the training program anddiagnosed with other cardiac diseases Participants taking beta-blockers for the duration of the intervention. Diagnosed with other neurologic or cachectic diseases or major surgery that may interfere with muscle quality (i.e. multiple sclerosis, ongoing cancer treatment or radiotherapy/ chemotherapy in the previous 6 months). Participating in another regular and intense (> 2 times a week) physical training programme within 2 months prior to enrolment. Ligament/muscle tear and/or other injuries within 6 months. Taking drugs (e.g. performance enhancing drugs) or nutritional supplements (e.g. protein powder) known to increase muscle mass. Inability to be scheduled for exercise therapy Insufficient comprehension of Dutch language or no informed consent.