SNPMiner Trials by Shray Alag


SNPMiner Trials: Clinical Trial Report


Report for Clinical Trial NCT01744561

Developed by Shray Alag, 2019.
SNP Clinical Trial Gene

Effects of a Partially Supervised Conditioning Program in CF: an International Multi-centre, Randomized Controlled Trial

Physical activity and exercise have become an accepted and valued component of Cystic Fibrosis care. Regular physical activity and exercise can slow the rate of decline of pulmonary function, improve physical fitness, and enhance quality of life. However, motivating people to be more active is challenging. Supervised exercise programs are expensive and labor intensive, and adherence falls off significantly once supervision ends. Unsupervised or partially supervised programs are less costly and more flexible, but compliance can be more problematic. The primary objective of this study is to evaluate the effects of a 12-months partially supervised exercise intervention along with regular motivation on forced expiratory volume in 1 second (FEV1) in a large international group of cystic fibrosis patients. Secondary endpoints include patient reported quality of life, as well as levels of anxiety and depression, and control of blood sugar. A total of 292 patients with cystic fibrosis 12 years and older with a FEV1 ≥35% predicted will be recruited. Following baseline assessments (2 visits) patients will be randomized into an intervention and a control group. Thereafter, they will be seen every 3 months for assessments in their centre for one year (4 follow-up visits). Along with individual counseling to increase vigorous physical activity by at least 3 hours per week on each clinic visit, the intervention group will document daily exercise and inactivity time and will receive a step counter and they will record their progress with a web-based program. They will also receive monthly phone calls from the study staff. After 6 months, they will continue with the step counter and web-based program for a further 6 months. The control group will receive access to this intervention after 12 months of standardized care. Should this relatively simple program prove successful, this will be made available on a wider scale internationally.

NCT01744561 Cystic Fibrosis
MeSH: Cystic Fibrosis

1 Interventions

Name: Exercise Intervention

Description: Add three hours of intense physical activities per week to baseline activities. Weekly exercise should include at least 30 minutes of strength building activities and at least two hours of aerobic activities. Exercise bouts lasting 20 min or longer will be counted with respect to total weekly training time.

Type: Behavioral

Exercise Intervention


Primary Outcomes

Measure: Change in forced expiratory volume in 1 second (FEV1; in % predicted using the average of two baseline measurements) from baseline to 6 months in the intervention group compared to controls.

Time: baseline and 6 months

Secondary Outcomes

Measure: Change in peak oxygen uptake (%predicted)

Time: baseline to 6 months and baseline to 12 months

Measure: Change in maximal aerobic power (%predicted)

Time: baseline to 6 months and baseline to 12 months

Measure: Change in measured steps per day

Time: baseline to 6 months and baseline to 12 months

Measure: Change in exercise steps per day

Time: baseline to 6 months and baseline to 12 months

Measure: Change in reported physical activity

Time: baseline to 6 months and baseline to 12 months

Measure: Change in forced expiratory volume in 1 second (FEV1; %predicted)

Time: baseline to 6 months and baseline to 12 months

Measure: Change in forced vital capacity (FVC; % predicted)

Time: baseline to 6 months and baseline to 12 months

Measure: Change in residual volume in percent of total lung capacity (RV/TLC; %)

Time: baseline to 6 months and baseline to 12 months

Measure: Time to first exacerbation

Time: baseline to 6 months and baseline to 12 months

Description: from diary

Measure: Number of upper respiratory tract infections

Time: baseline to 6 months and baseline to 12 months

Description: from questionnaire

Measure: Days on additional oral / intravenous antibiotics

Time: baseline to 6 months and baseline to 12 months

Measure: Change in body mass index (kg/m2)

Time: baseline to 6 months and baseline to 12 months

Description: estimated from skinfold thickness

Measure: Change in muscle mass (kg)

Time: baseline to 6 months and baseline to 12 months

Description: estimated from skinfold thickness

Measure: Change in percent body fat

Time: baseline to 6 months and baseline to 12 months

Description: from the revised Cystic Fibrosis health-related quality of life Questionnaire (CFQ-R questionnaire)

Measure: Change in Quality of Life scales

Time: baseline to 6 months and baseline to 12 months

Description: from Depression Anxiety Stress Scales

Measure: Change in depression, anxiety and stress scores

Time: baseline to 6 months and baseline to 12 months

Description: standardized oral glucose tolerance test only patients without diabetes mellitus

Measure: Change in plasma glucose concentrations 1 and 2 hours after a standardized glucose load

Time: baseline to 9 months

Description: causality as judged by investigator

Measure: Adverse events possibly or likely related to exercise

Time: baseline to 6 months and baseline to 12 months

Measure: Severe adverse events

Time: baseline to 6 months and baseline to 12 months

Measure: Serious adverse events

Time: baseline to 6 months and baseline to 12 months

Other Outcomes

Description: based on questionnaire and diary

Measure: Compliance with the exercise goal

Time: baseline to 6 months and baseline to 12 months

Description: based on nitrogen multiple breath washout, in selected centres only

Measure: Change in lung clearance index

Time: baseline to 6 months and baseline to 12 months

Description: based on accelerometry, in selected centres only

Measure: Change in time spent in moderate-and-vigorous physical activity

Time: baseline to 6 months and baseline to 12 months

Description: based on dual energy x-ray absorptiometry, in selected centres only

Measure: Change in bone mineral density and body composition

Time: baseline to 6 months and baseline to 12 months

Description: based on nuclear medicine scans, US centres only

Measure: Change in mucociliary clearance with exercise

Time: baseline to 6 months

Purpose: Treatment

Allocation: Randomized

Parallel Assignment


There is one SNP

SNPs


1 G551D

- Unstable condition precluding exercise (major hemoptysis or pneumothorax within the last 3 months, acute exacerbation and iv-antibiotics during the last 4 weeks, planned surgery, listed for lung transplantation, major musculoskeletal injuries such as fractures or sprains during the last 2 months, others according to the impression of the doctor) - Cardiac arrhythmias with exercise - Requiring additional oxygen with exercise - Recent diagnosis of diabetes 3 months prior to screening or at screening - Recent changes in medication 1 month or less prior to screening (systemic steroids, ibuprofen, inhaled antibiotics, mannitol, DNAse, hypertonic saline) - At least one G551D mutation and not on ivacaftor (VX770) yet but planned start or planned stop of ivacaftor during the trial - Colonization with Burkholderia cenocepacia Inclusion Criteria: - Confirmed diagnosis of Cystic Fibrosis - Age ≥12 years - Forced expiratory volume in 1 second (FEV1) ≥ 35% predicted - Access to the internet Exclusion Criteria: - Participation in another clinical trial up to 4 weeks prior to the first baseline visit - Pregnancy/Breastfeeding - Inability to exercise - More than 4 hours of reported strenuous physical activities per week currently or up to 3 months prior to baseline measurements and not already planned within the coming 6 months. --- G551D ---

- Unstable condition precluding exercise (major hemoptysis or pneumothorax within the last 3 months, acute exacerbation and iv-antibiotics during the last 4 weeks, planned surgery, listed for lung transplantation, major musculoskeletal injuries such as fractures or sprains during the last 2 months, others according to the impression of the doctor) - Cardiac arrhythmias with exercise - Requiring additional oxygen with exercise - Recent diagnosis of diabetes 3 months prior to screening or at screening - Recent changes in medication 1 month or less prior to screening (systemic steroids, ibuprofen, inhaled antibiotics, mannitol, DNAse, hypertonic saline) - At least one G551D mutation and not on ivacaftor (VX770) yet but planned start or planned stop of ivacaftor during the trial - Colonization with Burkholderia cenocepacia Cystic Fibrosis Cystic Fibrosis null --- G551D ---



HPO Nodes