Nieman 1993.

Methods	Study design: parallel‐group randomised controlled trial Location, number of centres: Appalachian State University Country: USA Study period: 12 weeks Methods of analysis: "measurement of immune system variables and cardiorespiratory fitness was conducted at baseline in both sedentary and highly conditioned elderly women. Following baseline testing, the 32 sedentary participants were randomly assigned to either the experimental or control group and retested after both 5 and 12 weeks of exercise training. The 5‐week testing was conducted to help determine if cardiorespiratory and immune system changes occur early in response to a moderate exercise programme. Maximal oxygen uptake (VO₂ max), weight and skin folds at the biceps, triceps, subscapular and supra iliac sites were measured at baseline in highly conditioned and sedentary participants and after 5 and 12 weeks of exercise training. Maximal graded treadmill testing using automated cardiorespiratory monitoring techniques (MMC Horizon System Exercise Evaluation Cart, Sensormedics, Yorba Linda, CA) was performed on all participants using a protocol developed in previous research with elderly participants. Blood specimens were collected from all participants in the seated position at 0700 hours after resting for a minimum of 10 minutes and abstaining from all food, beverages (except water) and vigorous physical activity for at least 12 hours. Samples were taken from the 32 sedentary participants at baseline and then again after 5 and 12 weeks of training. Samples from the 12 highly conditioned elderly participants were taken only at baseline and from the 13 young women only at the 12‐week testing. Routine complete blood counts (CBC) were performed using a Coulter STKS instrument (Coulter Electronics, Inc., Hialeah, FL). Heparinised whole blood was used for immune cell phenotyping for analysis of lymphocyte subset profiles" Statistical analysis: "results are expressed as means ± SE. Baseline comparisons between the elderly and young females were made using simple univariate t‐tests. A 2 x 3 repeated measures ANOVA with 1 between‐participants factor (walking versus calisthenic groups) and 1 within‐subject factor (baseline, 5 and 12 week times for testing) was used to analyse the training data. When Box's M suggested that the assumptions necessary for the univariate approach to repeated measures ANOVA was used. In the latter case Pillais trace statistic was used as the test statistic. With regard to comparison among specific means, only 2 comparisons were of interest to us. These were the contrast of the change in baseline measures with the 5th and 12th week measurements between the walking and calisthenic groups. The Dunn‐Sidak procedure was used to test the comparisons. The chi‐square test of association was used to test the relationship between incidence of URTI and varying levels of cardiorespiratory exercise according to group status (highly conditioned, walking and calisthenic groups) during the 12‐week study. The Pearson correlation coefficient was used to measure the linear correlationship between immune function and physical fitness (aerobic power and sum of 4 skin‐folds) in all elderly women at baseline"
Participants	Recruitment means: newspaper advertisements and direct mailings to local senior citizen groups Target participants: sedentary healthy elderly women N randomised: 32 women N completed: 30 completed: 14 (experimental) and 16 (control) Gender F = 30 Age: experimental 73.4 (1.1), control 73.5 (1.2) Inclusion criteria: "between the ages of 67 and 85; did not smoke or abuse alcohol; had not been on a reducing diet or exercise programme (≤ 3 moderate‐to‐vigorous aerobic sessions of > 20‐minute duration per week) for the previous 6 months; were non‐diseased (no current symptoms or signs suggestive of heart disease or cancer; did not use medications known to affect immune function)" Baseline details: age, sex, height, weight, BMI, sum of 4 skin‐folds, VO₂ max
Interventions	Setting of intervention: university activity centre Description of intervention: "participants in both groups met at the university activity centre and exercised 5 days/week, 30 to 40 minutes per session, under supervision. Participants in the experimental group engaged in 5 sessions of 30‐minute to 40‐minute brisk walking sessions per week at 60% of their heart rate reserve on either an outdoor or indoor (during bad weather) track. Participants warmed up for 5 minutes before each walking session with range‐of‐motion callisthenics. Total walking distances were recorded by the supervisor and heart rates monitored every 10 minutes through use of Polar pacer heart rate monitors (Polar USA, Inc.). Walking duration started at 30 minutes and was increased 2 minutes each week until participants were walking for 40 minutes by the mid‐point of the study. Training heart rates were recalculated after the 5‐week testing to adjust for improvement in cardio‐respiratory fitness and ensure that subjects maintained the 60% intensity level. To control for subject expectations and attention, the control group met in the same facility as the experimental group, and engaged in mild flexibility and musculoskeletal callisthenics under the direction of a second supervisor. Emphasis was placed on range‐of‐motion and stretching movements" Delivered by: supervised exercise Follow‐up period: 12 weeks Co‐interventions: none
Outcomes	Leukocyte and lymphocyte subsets; NK cell activity; VO₂ max; weight, sum of 4 skin‐folds; incidence of URTI Follow‐up period: 12 weeks
Notes	Study funding: this research was supported by a grant from the Cybex Corporation through the American College of Sports Medicine Foundation
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Unclear risk	The authors do not explain how the random sequence was generated.
Allocation concealment (selection bias)	Unclear risk	No description of how allocation was concealed: "randomised to either the experimental or control groups"
Blinding of participants and personnel (performance bias) All outcomes	High risk	The participants could not be blinded due to the nature of the intervention.
Blinding of outcome assessment (detection bias) All outcomes	High risk	Outcomes measured by participant self‐report.
Incomplete outcome data (attrition bias) All outcomes	Unclear risk	There were 2 participants with missing data.
Selective reporting (reporting bias)	Low risk	The outcomes prespecified in the methods were reported in the results.
Other bias	Low risk	The study seems to be free of other sources of bias.