Outcome
| Type |
Measure |
Description |
Time frame |
Safety issue |
| Primary |
Rate of Attendance |
Participants will be considered to have completed the fitness program if they attend at least 70% of the sessions |
16 weeks |
|
| Primary |
Rate of Completion |
Feasibility will be demonstrated if =60% of participants complete the fitness program |
16 weeks |
|
| Secondary |
Change in cardiopulmonary fitness as assessed by the 6-minute walk test |
summarize changes from the baseline to follow-up assessment including calculation of the effect size (mean within-subject difference divided by standard deviation of differences |
16 weeks |
|
| Secondary |
Change in strength |
summarize changes from the baseline to follow-up assessment including calculation of the effect size (mean within-subject difference divided by standard deviation of differences |
16 weeks |
|
| Secondary |
Change in QOL as assessed by the Functional Assessment of Cancer Therapy - General |
summarize changes from the baseline to follow-up assessment including calculation of the effect size (mean within-subject difference divided by standard deviation of differences |
16 weeks |
|
| Secondary |
Change in psychological well-bring as assessed by the Ryff Psychological Well-Being Scale (Min score: 42, Max score: 252. A higher score indicating higher psychological well-being) |
summarize changes from the baseline to follow-up assessment including calculation of the effect size (mean within-subject difference divided by standard deviation of differences |
16 weeks |
|
| Secondary |
Change in fatigue as assessed by Functional Assessment of Chronic Illness Therapy - Fatigue |
summarize changes from the baseline to follow-up assessment including calculation of the effect size (mean within-subject difference divided by standard deviation of differences |
16 weeks |
|
| Secondary |
Change in sleep quality as assessed by the Rand Medical Outcome Survey (MOS) Sleep Scale (min score: 0; max score: 100. A higher core indicates more sleep problems) |
summarize changes from the baseline to follow-up assessment including calculation of the effect size (mean within-subject difference divided by standard deviation of differences |
16 weeks |
|
| Secondary |
Change in anxiety as assessed by Hospital Anxiety and Depression Scale (HADS) (min score: 0; max score: 21. A higher score indicates more anxiety) |
summarize changes from the baseline to follow-up assessment including calculation of the effect size (mean within-subject difference divided by standard deviation of differences |
16 weeks |
|
| Secondary |
Change in depression as assessed by Hospital Anxiety and Depression Scale (HADS) (min score: 0; max score: 21. A higher score indicates more depression) |
summarize changes from the baseline to follow-up assessment including calculation of the effect size (mean within-subject difference divided by standard deviation of differences |
16 weeks |
|
| Secondary |
Change in body composition as assessed by change in total lean mass, extremity lean mass, total fat and trunk fat mass, as well as visceral adipose tissue mass which will be quantified using Hologic APEX 3.1 software. |
summarize changes from the baseline to follow-up assessment including calculation of the effect size (mean within-subject difference divided by standard deviation of differences |
16 weeks |
|
| Secondary |
Change in physical activity level as assessed using the using the Godin Leisure-Time Exercise Questionnaire. |
summarize changes from the baseline to follow-up assessment including calculation of the effect size (mean within-subject difference divided by standard deviation of differences |
16 weeks |
|
| Secondary |
Change in lipid profile |
Summarize changes from the baseline to follow-up assessment including calculation of the effect size (mean within-subject difference divided by standard deviation of differences). (total cholesterol: mg/dL; triglycerides: mg/dL; high-density lipoprotein cholesterol mg/dL; low-density lipoprotein cholesterol mg/dL; very low-density lipoprotein cholesterol: mg/dL; cholesterol/HDL ratio mg/dL). |
16 weeks |
|
| Secondary |
Change in hemoglobin A1c (%) |
Summarize changes from the baseline to follow-up assessment including calculation of the effect size (mean within-subject difference divided by standard deviation of differences), hemoglobin A1c reported as percentage of average blood sugar level (mg/dL or mmol/L), higher % corresponds to higher average blood sugar levels (normal A1C level is below 5.7%) |
16 weeks |
|
| Secondary |
Change in c-reactive protein (mg/L) |
Summarize changes from the baseline to follow-up assessment including calculation of the effect size (mean within-subject difference divided by standard deviation of differences), mg/L (hs-CRP level of 1 mg/L or lower indicates low risk of CVD, hs-CRP level of 1-3 mg/L indicates moderate risk of CVD, hs-CRP level of greater than 3 mg/L indicates high risk of CVD) |
16 weeks |
|
| Secondary |
Change in interleukin-6 (pg/mL) |
Summarize changes from the baseline to follow-up assessment including calculation of the effect size (mean within-subject difference divided by standard deviation of differences), pg/mL |
16 weeks |
|
| Secondary |
Change in tumor necrosis factor alpha (pg/mL) |
Summarize changes from the baseline to follow-up assessment including calculation of the effect size (mean within-subject difference divided by standard deviation of differences), pg/mL |
16 weeks |
|
| Secondary |
Change in insulin (mcU/mL) |
Summarize changes from the baseline to follow-up assessment including calculation of the effect size (mean within-subject difference divided by standard deviation of differences) (mcU/mL) |
16 weeks |
|
| Secondary |
Change in leptin (ng/mL) |
Summarize changes from the baseline to follow-up assessment including calculation of the effect size (mean within-subject difference divided by standard deviation of differences) (ng/mL) |
16 weeks |
|
| Secondary |
Change in adiponectin level (microgram/mL) |
Summarize changes from the baseline to follow-up assessment including calculation of the effect size (mean within-subject difference divided by standard deviation of differences) (microgram/mL) |
16 weeks |
|
| Secondary |
Change in insulin-like growth factor (ng/mL) |
Summarize changes from the baseline to follow-up assessment including calculation of the effect size (mean within-subject difference divided by standard deviation of differences) (ng/mL) |
16 weeks |
|
| Secondary |
Change in homeostatic model assessment of insulin resistance (estimates beta cell function (%B) and insulin sensitivity (%S), as percentages of a normal reference population) |
Summarize changes from the baseline to follow-up assessment including calculation of the effect size (mean within-subject difference divided by standard deviation of differences). Plasma glucose: mmol/L (or mg/dL), Insulin: pmol/L (or microunits/mL) |
16 weeks |
|
