Trial Outcomes & Findings for Health Education Materials With/Out a Physical Activity Program for Patients Who Have Undergone Treatment for High-Risk Stage II or Stage III Colon Cancer (NCT NCT00819208)
NCT ID: NCT00819208
Last Updated: 2026-04-24
Results Overview
Time from randomization to the first event that was either recurrent (local or distant) colon cancer, a new primary colorectal cancer, a second primary cancer, or death from any cause. The outcome for the disease-free survival will be presented as 5 year disease-free survival rate.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
889 participants
Primary outcome timeframe
5 Years after randomization
Results posted on
2026-04-24
Participant Flow
Participant milestones
| Measure |
Physical Activity Program + General Health Education Materials
Intervention Arm
exercise intervention: 3 phases Phase 1: Intensive intervention for 6 months Phase 2: Reduced intervention for months 6-12 Phase 3: Minimal intervention for months 12-36
counseling intervention: Achieving an increase in PA from baseline of ≥ 10 MET hours/week will require a significant amount of behavioural support. The intervention will comprise a 36-month individualized PA and behavioural support program with a PAC. This will include a personalized PA prescription which takes into account the baseline fitness test results, PA history, performance status and patient's personal PA preferences and any barriers to activity. Most patients are likely to choose a walking program however any PA of at least moderate intensity level is acceptable.
educational intervention: Once at the beginning of the program
laboratory biomarker analysis: Every 12 months
questionnaire administration: Every 6 months
study of socioeconomic and demographic variables: Every 6 months
fatigue assessment and management: Every 6 months
quality-of-life assessment: Every 6 months
Fitness testing: Objective fitness testing for both arms
|
General Health Education Materials
Control Arm
laboratory biomarker analysis: Every 12 months
questionnaire administration: Every 6 months
study of socioeconomic and demographic variables: Every 6 months
fatigue assessment and management: Every 6 months
quality-of-life assessment: Every 6 months
Educational Intervention: For Arm 2 just once at beginning of program.
Fitness testing: Objective fitness testing for both arms
|
|---|---|---|
|
Overall Study
STARTED
|
445
|
444
|
|
Overall Study
COMPLETED
|
445
|
444
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Physical Activity Program + General Health Education Materials
n=445 Participants
Intervention Arm
exercise intervention: 3 phases Phase 1: Intensive intervention for 6 months Phase 2: Reduced intervention for months 6-12 Phase 3: Minimal intervention for months 12-36
counseling intervention: Achieving an increase in PA from baseline of ≥ 10 MET hours/week will require a significant amount of behavioural support. The intervention will comprise a 36-month individualized PA and behavioural support program with a PAC. This will include a personalized PA prescription which takes into account the baseline fitness test results, PA history, performance status and patient's personal PA preferences and any barriers to activity. Most patients are likely to choose a walking program however any PA of at least moderate intensity level is acceptable.
educational intervention: Once at the beginning of the program
laboratory biomarker analysis: Every 12 months
questionnaire administration: Every 6 months
study of socioeconomic and demographic variables: Every 6 months
fatigue assessment and management: Every 6 months
quality-of-life assessment: Every 6 months
Fitness testing: Objective fitness testing for both arms
|
General Health Education Materials
n=444 Participants
Control Arm
laboratory biomarker analysis: Every 12 months
questionnaire administration: Every 6 months
study of socioeconomic and demographic variables: Every 6 months
fatigue assessment and management: Every 6 months
quality-of-life assessment: Every 6 months
Educational Intervention: For Arm 2 just once at beginning of program.
Fitness testing: Objective fitness testing for both arms
|
Total
n=889 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
61 years
n=445 Participants
|
61 years
n=444 Participants
|
61 years
n=889 Participants
|
|
Sex: Female, Male
Female
|
233 Participants
n=445 Participants
|
224 Participants
n=444 Participants
|
457 Participants
n=889 Participants
|
|
Sex: Female, Male
Male
|
212 Participants
n=445 Participants
|
220 Participants
n=444 Participants
|
432 Participants
n=889 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Region of Enrollment
Canada
|
270 participants
n=445 Participants
|
273 participants
n=444 Participants
|
543 participants
n=889 Participants
|
|
Region of Enrollment
United States
|
6 participants
n=445 Participants
|
3 participants
n=444 Participants
|
9 participants
n=889 Participants
|
|
Region of Enrollment
United Kingdom
|
16 participants
n=445 Participants
|
14 participants
n=444 Participants
|
30 participants
n=889 Participants
|
|
Region of Enrollment
Australia
|
146 participants
n=445 Participants
|
146 participants
n=444 Participants
|
292 participants
n=889 Participants
|
|
Region of Enrollment
France
|
5 participants
n=445 Participants
|
5 participants
n=444 Participants
|
10 participants
n=889 Participants
|
|
Region of Enrollment
Israel
|
2 participants
n=445 Participants
|
3 participants
n=444 Participants
|
5 participants
n=889 Participants
|
|
Disease Stage
High-risk stage II adenocarcinoma
|
43 Participants
n=445 Participants
|
44 Participants
n=444 Participants
|
87 Participants
n=889 Participants
|
|
Disease Stage
Stage III adenocarcinoma
|
402 Participants
n=445 Participants
|
400 Participants
n=444 Participants
|
802 Participants
n=889 Participants
|
PRIMARY outcome
Timeframe: 5 Years after randomizationPopulation: All patients randomized.
Time from randomization to the first event that was either recurrent (local or distant) colon cancer, a new primary colorectal cancer, a second primary cancer, or death from any cause. The outcome for the disease-free survival will be presented as 5 year disease-free survival rate.
Outcome measures
| Measure |
Physical Activity Program + General Health Education Materials
n=445 Participants
Intervention Arm
exercise intervention: 3 phases Phase 1: Intensive intervention for 6 months Phase 2: Reduced intervention for months 6-12 Phase 3: Minimal intervention for months 12-36
counseling intervention: Achieving an increase in PA from baseline of ≥ 10 MET hours/week will require a significant amount of behavioural support. The intervention will comprise a 36-month individualized PA and behavioural support program with a PAC. This will include a personalized PA prescription which takes into account the baseline fitness test results, PA history, performance status and patient's personal PA preferences and any barriers to activity. Most patients are likely to choose a walking program however any PA of at least moderate intensity level is acceptable.
educational intervention: Once at the beginning of the program
laboratory biomarker analysis: Every 12 months
questionnaire administration: Every 6 months
study of socioeconomic and demographic variables: Every 6 months
fatigue assessment and management: Every 6 months
quality-of-life assessment: Every 6 months
Fitness testing: Objective fitness testing for both arms
|
General Health Education Materials
n=444 Participants
Control Arm
laboratory biomarker analysis: Every 12 months
questionnaire administration: Every 6 months
study of socioeconomic and demographic variables: Every 6 months
fatigue assessment and management: Every 6 months
quality-of-life assessment: Every 6 months
Educational Intervention: For Arm 2 just once at beginning of program.
Fitness testing: Objective fitness testing for both arms
|
|---|---|---|
|
Disease-free Survival
|
80.3 percentage of participants
Interval 76.0 to 83.9
|
73.9 percentage of participants
Interval 69.3 to 78.0
|
SECONDARY outcome
Timeframe: 8 years after randomization.Population: All participants randomized.
Time from randomization to death of any cause. Patients last known to be alive are censored at their last contact date. The outcome for overall survival will be presented as 8 year overall survival rate.
Outcome measures
| Measure |
Physical Activity Program + General Health Education Materials
n=445 Participants
Intervention Arm
exercise intervention: 3 phases Phase 1: Intensive intervention for 6 months Phase 2: Reduced intervention for months 6-12 Phase 3: Minimal intervention for months 12-36
counseling intervention: Achieving an increase in PA from baseline of ≥ 10 MET hours/week will require a significant amount of behavioural support. The intervention will comprise a 36-month individualized PA and behavioural support program with a PAC. This will include a personalized PA prescription which takes into account the baseline fitness test results, PA history, performance status and patient's personal PA preferences and any barriers to activity. Most patients are likely to choose a walking program however any PA of at least moderate intensity level is acceptable.
educational intervention: Once at the beginning of the program
laboratory biomarker analysis: Every 12 months
questionnaire administration: Every 6 months
study of socioeconomic and demographic variables: Every 6 months
fatigue assessment and management: Every 6 months
quality-of-life assessment: Every 6 months
Fitness testing: Objective fitness testing for both arms
|
General Health Education Materials
n=444 Participants
Control Arm
laboratory biomarker analysis: Every 12 months
questionnaire administration: Every 6 months
study of socioeconomic and demographic variables: Every 6 months
fatigue assessment and management: Every 6 months
quality-of-life assessment: Every 6 months
Educational Intervention: For Arm 2 just once at beginning of program.
Fitness testing: Objective fitness testing for both arms
|
|---|---|---|
|
Overall Survival
|
90.3 percentage of participants
Interval 86.5 to 93.0
|
83.2 percentage of participants
Interval 78.7 to 86.9
|
Adverse Events
Physical Activity Program + General Health Education Materials
Serious events: 0 serious events
Other events: 351 other events
Deaths: 41 deaths
General Health Education Materials
Serious events: 0 serious events
Other events: 352 other events
Deaths: 66 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Physical Activity Program + General Health Education Materials
n=428 participants at risk
Intervention Arm
exercise intervention: 3 phases Phase 1: Intensive intervention for 6 months Phase 2: Reduced intervention for months 6-12 Phase 3: Minimal intervention for months 12-36
counseling intervention: Achieving an increase in PA from baseline of ≥ 10 MET hours/week will require a significant amount of behavioural support. The intervention will comprise a 36-month individualized PA and behavioural support program with a PAC. This will include a personalized PA prescription which takes into account the baseline fitness test results, PA history, performance status and patient's personal PA preferences and any barriers to activity. Most patients are likely to choose a walking program however any PA of at least moderate intensity level is acceptable.
educational intervention: Once at the beginning of the program
laboratory biomarker analysis: Every 12 months
questionnaire administration: Every 6 months
study of socioeconomic and demographic variables: Every 6 months
fatigue assessment and management: Every 6 months
quality-of-life assessment: Every 6 months
Fitness testing: Objective fitness testing for both arms
|
General Health Education Materials
n=461 participants at risk
Control Arm
laboratory biomarker analysis: Every 12 months
questionnaire administration: Every 6 months
study of socioeconomic and demographic variables: Every 6 months
fatigue assessment and management: Every 6 months
quality-of-life assessment: Every 6 months
Educational Intervention: For Arm 2 just once at beginning of program.
Fitness testing: Objective fitness testing for both arms
|
|---|---|---|
|
Cardiac disorders
Hypertension
|
6.5%
28/428 • All-cause mortality was assessed every 6 months for 3 years and then annually for 10 years or until death. Assessment of serious and other adverse events was repeated every 6 months until 3 years or end of treatment.
The analyses included 428 patients who had been randomly assigned to the Physical Activity Program + General Health Education Materials arm and had participated in at least one exercise session and 461 patients who had been randomly assigned to the General Health Education Materials arm (444 patients) or to the other arm but had not participated in any exercise sessions (17 patients) excepted for all-cause mortality which included all patients as randomized
|
7.4%
34/461 • All-cause mortality was assessed every 6 months for 3 years and then annually for 10 years or until death. Assessment of serious and other adverse events was repeated every 6 months until 3 years or end of treatment.
The analyses included 428 patients who had been randomly assigned to the Physical Activity Program + General Health Education Materials arm and had participated in at least one exercise session and 461 patients who had been randomly assigned to the General Health Education Materials arm (444 patients) or to the other arm but had not participated in any exercise sessions (17 patients) excepted for all-cause mortality which included all patients as randomized
|
|
General disorders
Fatigue
|
30.6%
131/428 • All-cause mortality was assessed every 6 months for 3 years and then annually for 10 years or until death. Assessment of serious and other adverse events was repeated every 6 months until 3 years or end of treatment.
The analyses included 428 patients who had been randomly assigned to the Physical Activity Program + General Health Education Materials arm and had participated in at least one exercise session and 461 patients who had been randomly assigned to the General Health Education Materials arm (444 patients) or to the other arm but had not participated in any exercise sessions (17 patients) excepted for all-cause mortality which included all patients as randomized
|
29.7%
137/461 • All-cause mortality was assessed every 6 months for 3 years and then annually for 10 years or until death. Assessment of serious and other adverse events was repeated every 6 months until 3 years or end of treatment.
The analyses included 428 patients who had been randomly assigned to the Physical Activity Program + General Health Education Materials arm and had participated in at least one exercise session and 461 patients who had been randomly assigned to the General Health Education Materials arm (444 patients) or to the other arm but had not participated in any exercise sessions (17 patients) excepted for all-cause mortality which included all patients as randomized
|
|
General disorders
Insomnia
|
12.4%
53/428 • All-cause mortality was assessed every 6 months for 3 years and then annually for 10 years or until death. Assessment of serious and other adverse events was repeated every 6 months until 3 years or end of treatment.
The analyses included 428 patients who had been randomly assigned to the Physical Activity Program + General Health Education Materials arm and had participated in at least one exercise session and 461 patients who had been randomly assigned to the General Health Education Materials arm (444 patients) or to the other arm but had not participated in any exercise sessions (17 patients) excepted for all-cause mortality which included all patients as randomized
|
13.0%
60/461 • All-cause mortality was assessed every 6 months for 3 years and then annually for 10 years or until death. Assessment of serious and other adverse events was repeated every 6 months until 3 years or end of treatment.
The analyses included 428 patients who had been randomly assigned to the Physical Activity Program + General Health Education Materials arm and had participated in at least one exercise session and 461 patients who had been randomly assigned to the General Health Education Materials arm (444 patients) or to the other arm but had not participated in any exercise sessions (17 patients) excepted for all-cause mortality which included all patients as randomized
|
|
Endocrine disorders
Hot flashes
|
4.0%
17/428 • All-cause mortality was assessed every 6 months for 3 years and then annually for 10 years or until death. Assessment of serious and other adverse events was repeated every 6 months until 3 years or end of treatment.
The analyses included 428 patients who had been randomly assigned to the Physical Activity Program + General Health Education Materials arm and had participated in at least one exercise session and 461 patients who had been randomly assigned to the General Health Education Materials arm (444 patients) or to the other arm but had not participated in any exercise sessions (17 patients) excepted for all-cause mortality which included all patients as randomized
|
5.2%
24/461 • All-cause mortality was assessed every 6 months for 3 years and then annually for 10 years or until death. Assessment of serious and other adverse events was repeated every 6 months until 3 years or end of treatment.
The analyses included 428 patients who had been randomly assigned to the Physical Activity Program + General Health Education Materials arm and had participated in at least one exercise session and 461 patients who had been randomly assigned to the General Health Education Materials arm (444 patients) or to the other arm but had not participated in any exercise sessions (17 patients) excepted for all-cause mortality which included all patients as randomized
|
|
Gastrointestinal disorders
Constipation
|
10.5%
45/428 • All-cause mortality was assessed every 6 months for 3 years and then annually for 10 years or until death. Assessment of serious and other adverse events was repeated every 6 months until 3 years or end of treatment.
The analyses included 428 patients who had been randomly assigned to the Physical Activity Program + General Health Education Materials arm and had participated in at least one exercise session and 461 patients who had been randomly assigned to the General Health Education Materials arm (444 patients) or to the other arm but had not participated in any exercise sessions (17 patients) excepted for all-cause mortality which included all patients as randomized
|
10.2%
47/461 • All-cause mortality was assessed every 6 months for 3 years and then annually for 10 years or until death. Assessment of serious and other adverse events was repeated every 6 months until 3 years or end of treatment.
The analyses included 428 patients who had been randomly assigned to the Physical Activity Program + General Health Education Materials arm and had participated in at least one exercise session and 461 patients who had been randomly assigned to the General Health Education Materials arm (444 patients) or to the other arm but had not participated in any exercise sessions (17 patients) excepted for all-cause mortality which included all patients as randomized
|
|
Gastrointestinal disorders
Diarrhea
|
11.9%
51/428 • All-cause mortality was assessed every 6 months for 3 years and then annually for 10 years or until death. Assessment of serious and other adverse events was repeated every 6 months until 3 years or end of treatment.
The analyses included 428 patients who had been randomly assigned to the Physical Activity Program + General Health Education Materials arm and had participated in at least one exercise session and 461 patients who had been randomly assigned to the General Health Education Materials arm (444 patients) or to the other arm but had not participated in any exercise sessions (17 patients) excepted for all-cause mortality which included all patients as randomized
|
15.0%
69/461 • All-cause mortality was assessed every 6 months for 3 years and then annually for 10 years or until death. Assessment of serious and other adverse events was repeated every 6 months until 3 years or end of treatment.
The analyses included 428 patients who had been randomly assigned to the Physical Activity Program + General Health Education Materials arm and had participated in at least one exercise session and 461 patients who had been randomly assigned to the General Health Education Materials arm (444 patients) or to the other arm but had not participated in any exercise sessions (17 patients) excepted for all-cause mortality which included all patients as randomized
|
|
Gastrointestinal disorders
Heartburn
|
7.9%
34/428 • All-cause mortality was assessed every 6 months for 3 years and then annually for 10 years or until death. Assessment of serious and other adverse events was repeated every 6 months until 3 years or end of treatment.
The analyses included 428 patients who had been randomly assigned to the Physical Activity Program + General Health Education Materials arm and had participated in at least one exercise session and 461 patients who had been randomly assigned to the General Health Education Materials arm (444 patients) or to the other arm but had not participated in any exercise sessions (17 patients) excepted for all-cause mortality which included all patients as randomized
|
8.2%
38/461 • All-cause mortality was assessed every 6 months for 3 years and then annually for 10 years or until death. Assessment of serious and other adverse events was repeated every 6 months until 3 years or end of treatment.
The analyses included 428 patients who had been randomly assigned to the Physical Activity Program + General Health Education Materials arm and had participated in at least one exercise session and 461 patients who had been randomly assigned to the General Health Education Materials arm (444 patients) or to the other arm but had not participated in any exercise sessions (17 patients) excepted for all-cause mortality which included all patients as randomized
|
|
Gastrointestinal disorders
Nausea
|
8.9%
38/428 • All-cause mortality was assessed every 6 months for 3 years and then annually for 10 years or until death. Assessment of serious and other adverse events was repeated every 6 months until 3 years or end of treatment.
The analyses included 428 patients who had been randomly assigned to the Physical Activity Program + General Health Education Materials arm and had participated in at least one exercise session and 461 patients who had been randomly assigned to the General Health Education Materials arm (444 patients) or to the other arm but had not participated in any exercise sessions (17 patients) excepted for all-cause mortality which included all patients as randomized
|
5.9%
27/461 • All-cause mortality was assessed every 6 months for 3 years and then annually for 10 years or until death. Assessment of serious and other adverse events was repeated every 6 months until 3 years or end of treatment.
The analyses included 428 patients who had been randomly assigned to the Physical Activity Program + General Health Education Materials arm and had participated in at least one exercise session and 461 patients who had been randomly assigned to the General Health Education Materials arm (444 patients) or to the other arm but had not participated in any exercise sessions (17 patients) excepted for all-cause mortality which included all patients as randomized
|
|
Infections and infestations
Infection (other)
|
8.9%
38/428 • All-cause mortality was assessed every 6 months for 3 years and then annually for 10 years or until death. Assessment of serious and other adverse events was repeated every 6 months until 3 years or end of treatment.
The analyses included 428 patients who had been randomly assigned to the Physical Activity Program + General Health Education Materials arm and had participated in at least one exercise session and 461 patients who had been randomly assigned to the General Health Education Materials arm (444 patients) or to the other arm but had not participated in any exercise sessions (17 patients) excepted for all-cause mortality which included all patients as randomized
|
4.6%
21/461 • All-cause mortality was assessed every 6 months for 3 years and then annually for 10 years or until death. Assessment of serious and other adverse events was repeated every 6 months until 3 years or end of treatment.
The analyses included 428 patients who had been randomly assigned to the Physical Activity Program + General Health Education Materials arm and had participated in at least one exercise session and 461 patients who had been randomly assigned to the General Health Education Materials arm (444 patients) or to the other arm but had not participated in any exercise sessions (17 patients) excepted for all-cause mortality which included all patients as randomized
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
6.3%
27/428 • All-cause mortality was assessed every 6 months for 3 years and then annually for 10 years or until death. Assessment of serious and other adverse events was repeated every 6 months until 3 years or end of treatment.
The analyses included 428 patients who had been randomly assigned to the Physical Activity Program + General Health Education Materials arm and had participated in at least one exercise session and 461 patients who had been randomly assigned to the General Health Education Materials arm (444 patients) or to the other arm but had not participated in any exercise sessions (17 patients) excepted for all-cause mortality which included all patients as randomized
|
5.9%
27/461 • All-cause mortality was assessed every 6 months for 3 years and then annually for 10 years or until death. Assessment of serious and other adverse events was repeated every 6 months until 3 years or end of treatment.
The analyses included 428 patients who had been randomly assigned to the Physical Activity Program + General Health Education Materials arm and had participated in at least one exercise session and 461 patients who had been randomly assigned to the General Health Education Materials arm (444 patients) or to the other arm but had not participated in any exercise sessions (17 patients) excepted for all-cause mortality which included all patients as randomized
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal (other)
|
5.6%
24/428 • All-cause mortality was assessed every 6 months for 3 years and then annually for 10 years or until death. Assessment of serious and other adverse events was repeated every 6 months until 3 years or end of treatment.
The analyses included 428 patients who had been randomly assigned to the Physical Activity Program + General Health Education Materials arm and had participated in at least one exercise session and 461 patients who had been randomly assigned to the General Health Education Materials arm (444 patients) or to the other arm but had not participated in any exercise sessions (17 patients) excepted for all-cause mortality which included all patients as randomized
|
1.3%
6/461 • All-cause mortality was assessed every 6 months for 3 years and then annually for 10 years or until death. Assessment of serious and other adverse events was repeated every 6 months until 3 years or end of treatment.
The analyses included 428 patients who had been randomly assigned to the Physical Activity Program + General Health Education Materials arm and had participated in at least one exercise session and 461 patients who had been randomly assigned to the General Health Education Materials arm (444 patients) or to the other arm but had not participated in any exercise sessions (17 patients) excepted for all-cause mortality which included all patients as randomized
|
|
Psychiatric disorders
Anxiety
|
7.7%
33/428 • All-cause mortality was assessed every 6 months for 3 years and then annually for 10 years or until death. Assessment of serious and other adverse events was repeated every 6 months until 3 years or end of treatment.
The analyses included 428 patients who had been randomly assigned to the Physical Activity Program + General Health Education Materials arm and had participated in at least one exercise session and 461 patients who had been randomly assigned to the General Health Education Materials arm (444 patients) or to the other arm but had not participated in any exercise sessions (17 patients) excepted for all-cause mortality which included all patients as randomized
|
7.2%
33/461 • All-cause mortality was assessed every 6 months for 3 years and then annually for 10 years or until death. Assessment of serious and other adverse events was repeated every 6 months until 3 years or end of treatment.
The analyses included 428 patients who had been randomly assigned to the Physical Activity Program + General Health Education Materials arm and had participated in at least one exercise session and 461 patients who had been randomly assigned to the General Health Education Materials arm (444 patients) or to the other arm but had not participated in any exercise sessions (17 patients) excepted for all-cause mortality which included all patients as randomized
|
|
Psychiatric disorders
Depression
|
7.9%
34/428 • All-cause mortality was assessed every 6 months for 3 years and then annually for 10 years or until death. Assessment of serious and other adverse events was repeated every 6 months until 3 years or end of treatment.
The analyses included 428 patients who had been randomly assigned to the Physical Activity Program + General Health Education Materials arm and had participated in at least one exercise session and 461 patients who had been randomly assigned to the General Health Education Materials arm (444 patients) or to the other arm but had not participated in any exercise sessions (17 patients) excepted for all-cause mortality which included all patients as randomized
|
6.3%
29/461 • All-cause mortality was assessed every 6 months for 3 years and then annually for 10 years or until death. Assessment of serious and other adverse events was repeated every 6 months until 3 years or end of treatment.
The analyses included 428 patients who had been randomly assigned to the Physical Activity Program + General Health Education Materials arm and had participated in at least one exercise session and 461 patients who had been randomly assigned to the General Health Education Materials arm (444 patients) or to the other arm but had not participated in any exercise sessions (17 patients) excepted for all-cause mortality which included all patients as randomized
|
|
Nervous system disorders
Neuropathy (sensory)
|
47.7%
204/428 • All-cause mortality was assessed every 6 months for 3 years and then annually for 10 years or until death. Assessment of serious and other adverse events was repeated every 6 months until 3 years or end of treatment.
The analyses included 428 patients who had been randomly assigned to the Physical Activity Program + General Health Education Materials arm and had participated in at least one exercise session and 461 patients who had been randomly assigned to the General Health Education Materials arm (444 patients) or to the other arm but had not participated in any exercise sessions (17 patients) excepted for all-cause mortality which included all patients as randomized
|
47.3%
218/461 • All-cause mortality was assessed every 6 months for 3 years and then annually for 10 years or until death. Assessment of serious and other adverse events was repeated every 6 months until 3 years or end of treatment.
The analyses included 428 patients who had been randomly assigned to the Physical Activity Program + General Health Education Materials arm and had participated in at least one exercise session and 461 patients who had been randomly assigned to the General Health Education Materials arm (444 patients) or to the other arm but had not participated in any exercise sessions (17 patients) excepted for all-cause mortality which included all patients as randomized
|
|
Musculoskeletal and connective tissue disorders
Abdominal pain
|
12.6%
54/428 • All-cause mortality was assessed every 6 months for 3 years and then annually for 10 years or until death. Assessment of serious and other adverse events was repeated every 6 months until 3 years or end of treatment.
The analyses included 428 patients who had been randomly assigned to the Physical Activity Program + General Health Education Materials arm and had participated in at least one exercise session and 461 patients who had been randomly assigned to the General Health Education Materials arm (444 patients) or to the other arm but had not participated in any exercise sessions (17 patients) excepted for all-cause mortality which included all patients as randomized
|
12.1%
56/461 • All-cause mortality was assessed every 6 months for 3 years and then annually for 10 years or until death. Assessment of serious and other adverse events was repeated every 6 months until 3 years or end of treatment.
The analyses included 428 patients who had been randomly assigned to the Physical Activity Program + General Health Education Materials arm and had participated in at least one exercise session and 461 patients who had been randomly assigned to the General Health Education Materials arm (444 patients) or to the other arm but had not participated in any exercise sessions (17 patients) excepted for all-cause mortality which included all patients as randomized
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
12.6%
54/428 • All-cause mortality was assessed every 6 months for 3 years and then annually for 10 years or until death. Assessment of serious and other adverse events was repeated every 6 months until 3 years or end of treatment.
The analyses included 428 patients who had been randomly assigned to the Physical Activity Program + General Health Education Materials arm and had participated in at least one exercise session and 461 patients who had been randomly assigned to the General Health Education Materials arm (444 patients) or to the other arm but had not participated in any exercise sessions (17 patients) excepted for all-cause mortality which included all patients as randomized
|
11.1%
51/461 • All-cause mortality was assessed every 6 months for 3 years and then annually for 10 years or until death. Assessment of serious and other adverse events was repeated every 6 months until 3 years or end of treatment.
The analyses included 428 patients who had been randomly assigned to the Physical Activity Program + General Health Education Materials arm and had participated in at least one exercise session and 461 patients who had been randomly assigned to the General Health Education Materials arm (444 patients) or to the other arm but had not participated in any exercise sessions (17 patients) excepted for all-cause mortality which included all patients as randomized
|
|
Musculoskeletal and connective tissue disorders
Extremity limb pain
|
8.2%
35/428 • All-cause mortality was assessed every 6 months for 3 years and then annually for 10 years or until death. Assessment of serious and other adverse events was repeated every 6 months until 3 years or end of treatment.
The analyses included 428 patients who had been randomly assigned to the Physical Activity Program + General Health Education Materials arm and had participated in at least one exercise session and 461 patients who had been randomly assigned to the General Health Education Materials arm (444 patients) or to the other arm but had not participated in any exercise sessions (17 patients) excepted for all-cause mortality which included all patients as randomized
|
7.2%
33/461 • All-cause mortality was assessed every 6 months for 3 years and then annually for 10 years or until death. Assessment of serious and other adverse events was repeated every 6 months until 3 years or end of treatment.
The analyses included 428 patients who had been randomly assigned to the Physical Activity Program + General Health Education Materials arm and had participated in at least one exercise session and 461 patients who had been randomly assigned to the General Health Education Materials arm (444 patients) or to the other arm but had not participated in any exercise sessions (17 patients) excepted for all-cause mortality which included all patients as randomized
|
|
General disorders
Head pain/headache
|
10.0%
43/428 • All-cause mortality was assessed every 6 months for 3 years and then annually for 10 years or until death. Assessment of serious and other adverse events was repeated every 6 months until 3 years or end of treatment.
The analyses included 428 patients who had been randomly assigned to the Physical Activity Program + General Health Education Materials arm and had participated in at least one exercise session and 461 patients who had been randomly assigned to the General Health Education Materials arm (444 patients) or to the other arm but had not participated in any exercise sessions (17 patients) excepted for all-cause mortality which included all patients as randomized
|
8.2%
38/461 • All-cause mortality was assessed every 6 months for 3 years and then annually for 10 years or until death. Assessment of serious and other adverse events was repeated every 6 months until 3 years or end of treatment.
The analyses included 428 patients who had been randomly assigned to the Physical Activity Program + General Health Education Materials arm and had participated in at least one exercise session and 461 patients who had been randomly assigned to the General Health Education Materials arm (444 patients) or to the other arm but had not participated in any exercise sessions (17 patients) excepted for all-cause mortality which included all patients as randomized
|
|
Musculoskeletal and connective tissue disorders
Joint pain
|
16.8%
72/428 • All-cause mortality was assessed every 6 months for 3 years and then annually for 10 years or until death. Assessment of serious and other adverse events was repeated every 6 months until 3 years or end of treatment.
The analyses included 428 patients who had been randomly assigned to the Physical Activity Program + General Health Education Materials arm and had participated in at least one exercise session and 461 patients who had been randomly assigned to the General Health Education Materials arm (444 patients) or to the other arm but had not participated in any exercise sessions (17 patients) excepted for all-cause mortality which included all patients as randomized
|
20.0%
92/461 • All-cause mortality was assessed every 6 months for 3 years and then annually for 10 years or until death. Assessment of serious and other adverse events was repeated every 6 months until 3 years or end of treatment.
The analyses included 428 patients who had been randomly assigned to the Physical Activity Program + General Health Education Materials arm and had participated in at least one exercise session and 461 patients who had been randomly assigned to the General Health Education Materials arm (444 patients) or to the other arm but had not participated in any exercise sessions (17 patients) excepted for all-cause mortality which included all patients as randomized
|
|
Musculoskeletal and connective tissue disorders
Muscle pain
|
7.5%
32/428 • All-cause mortality was assessed every 6 months for 3 years and then annually for 10 years or until death. Assessment of serious and other adverse events was repeated every 6 months until 3 years or end of treatment.
The analyses included 428 patients who had been randomly assigned to the Physical Activity Program + General Health Education Materials arm and had participated in at least one exercise session and 461 patients who had been randomly assigned to the General Health Education Materials arm (444 patients) or to the other arm but had not participated in any exercise sessions (17 patients) excepted for all-cause mortality which included all patients as randomized
|
6.3%
29/461 • All-cause mortality was assessed every 6 months for 3 years and then annually for 10 years or until death. Assessment of serious and other adverse events was repeated every 6 months until 3 years or end of treatment.
The analyses included 428 patients who had been randomly assigned to the Physical Activity Program + General Health Education Materials arm and had participated in at least one exercise session and 461 patients who had been randomly assigned to the General Health Education Materials arm (444 patients) or to the other arm but had not participated in any exercise sessions (17 patients) excepted for all-cause mortality which included all patients as randomized
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
7.5%
32/428 • All-cause mortality was assessed every 6 months for 3 years and then annually for 10 years or until death. Assessment of serious and other adverse events was repeated every 6 months until 3 years or end of treatment.
The analyses included 428 patients who had been randomly assigned to the Physical Activity Program + General Health Education Materials arm and had participated in at least one exercise session and 461 patients who had been randomly assigned to the General Health Education Materials arm (444 patients) or to the other arm but had not participated in any exercise sessions (17 patients) excepted for all-cause mortality which included all patients as randomized
|
7.6%
35/461 • All-cause mortality was assessed every 6 months for 3 years and then annually for 10 years or until death. Assessment of serious and other adverse events was repeated every 6 months until 3 years or end of treatment.
The analyses included 428 patients who had been randomly assigned to the Physical Activity Program + General Health Education Materials arm and had participated in at least one exercise session and 461 patients who had been randomly assigned to the General Health Education Materials arm (444 patients) or to the other arm but had not participated in any exercise sessions (17 patients) excepted for all-cause mortality which included all patients as randomized
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
10.5%
45/428 • All-cause mortality was assessed every 6 months for 3 years and then annually for 10 years or until death. Assessment of serious and other adverse events was repeated every 6 months until 3 years or end of treatment.
The analyses included 428 patients who had been randomly assigned to the Physical Activity Program + General Health Education Materials arm and had participated in at least one exercise session and 461 patients who had been randomly assigned to the General Health Education Materials arm (444 patients) or to the other arm but had not participated in any exercise sessions (17 patients) excepted for all-cause mortality which included all patients as randomized
|
8.0%
37/461 • All-cause mortality was assessed every 6 months for 3 years and then annually for 10 years or until death. Assessment of serious and other adverse events was repeated every 6 months until 3 years or end of treatment.
The analyses included 428 patients who had been randomly assigned to the Physical Activity Program + General Health Education Materials arm and had participated in at least one exercise session and 461 patients who had been randomly assigned to the General Health Education Materials arm (444 patients) or to the other arm but had not participated in any exercise sessions (17 patients) excepted for all-cause mortality which included all patients as randomized
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place