Effects of Hypopressive Exercise Associated With Strength and Resistance Training in the Management of Fatigue, Urinary Incontinence Symptoms, Sexual Function and Quality of Life in Women Treated for Gynecological Cancer
Phase: NA
Conditions: Gynecologic Cancer
Sponsor: Universidade Federal de Sao Carlos

Effects of Hypopressive Exercise Associated With Strength and Resistance Training 
in the Management of Fatigue, Urinary Incontinence Symptoms, Sexual Function and 
Quality of Life in Women Treated for Gynecological Cancer 
 
Study Protocol (23-08-2021) 
 
Research design 
Experimental, single-blind randomized clinical trial type.  
 
Determination of sample size 
The sample size was calculated using the GPower version 3.1 software, considering a size of 
effect, Cohen's d of 0.2, to achieve a power of 80%, with a significance level of 5%. was used 
the analysis of variance of repeated measures, considering interaction between and within 
groups using 2 measurements. Thirty-six participants (18 per group) were suggested. 
 
Randomization and blinding 
Participants will be assigned randomly assigned to one of the two groups studied 
(Hipopresive exercise group, HEG; conventional exercise group, CEG). Randomization will 
be performed by a member of the team, blinded to the study protocol. A computer program 
will 
be 
used 
to 
perform 
the 
randomization 
(https://www.graphpad.com/quickcalcs/randomize1.cfm). Both groups will receive 4 weeks 
of supervised training with a frequency of three times a week, with an approximate duration 
of 60 minutes each session. Figure 1 presents the flowchart with the experimental design of 
the study. 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Figure 1. 
Interview and eligibility 
Baseline assessment 
Randomization 
4 week of intervention 
4 week of intervention 
Final assessment 
Final assessment 
HEG 
CEG 

 
Protocol of therapeutic exercise 
Both groups of exercises will train three times a week, twice in a synchronous online way 
and once in an asynchronous way, considering a standardized exercise guide. In all of the 
intervention sessions, the conventional exercises will be guided by the standardized exercise 
guide previously developed by the team of the study for 4 weeks. Each session will last 
approximately 60 minutes. In all sessions, exercise perception (using the Borg scale), 
respiratory rate and heart rate will be monitored, considering instructions via remote. For 
aerobic training, a light to moderate intensity will be considered (Borg 9-13). Resistance 
exercises will be carried out using large muscle groups and the participants' body weight. All 
the exercise sessions will be the same for the groups and will begin with a five-minute warm-
up with exercises that involve large muscle groups in a perceived exercise rating of 10 to 12 
on the Borg scale and the sessions conclude with a 10 minutes that include dynamic and static 
muscle stretching activities of the main muscle groups worked in the session. In the first 
week of training, a familiarization with the perception of perceived effort will be carried out 
using the Borg scale. 
The strength training will consist of 3 sets of 8-12 repetitions of 8 exercises, using leg 
extensions and lower limbs, biceps curls and extensions, lunges, chest curls, abdominal curls, 
shoulder curls and back extension. Participants will perform exercises without charge in all 
sessions. The training progress will be related to the increase in volume according to what 
corresponds to each week: a) weeks 1 and 2 (3 sets of 8 repetitions, adaptation weeks), b) 
week 3 (3 sets of 10 repetitions) and c) week 4 (3 sets of 12 repetitions). 
 
Hypopressive Exercise Protocol 
The hypopressive exercises will be carried out by the GEH group at the end of the strength 
and resistance training session. It will be considered the static hypopressive exercise in the 
supine position, with a variant of arms in flexion, abduction and extension, consisting of 3 
exercises. The dosage will consist of 3 series of each exercise, using a protocol adapted from 
the previous study by Cabañas and Chapinal. Participants must perform 3 cycles of deep 
inspiration (nose) and forced breathing (mouth). After the last breath, the participants will be 
instructed to maintain the position performing 3 cycles of normal breathing, without 
performing the apnea, to guarantee the safety of the user and that the intervention is remote. 
During the breathing phase, participants will be instructed to perform pelvic floor 
contraction. The procedure must be repeated 3 times in each variant of arms. 
 
Recruitment 
Participants will be recruited through the referral of a medical oncologist from the Regional 
Hospital of Talca in Chile. Potential study participants will be called for an initial evaluation 
where eligibility will be determined and the objectives of the research will be explained. 
Participants who agree to participate must sign an informed consent. 
 

Generation and hiding of sequences 
After selecting the sample and performing the baseline evaluations, the participants will be 
randomly assigned to one of the two study groups. Randomization will be performed by a 
member of the team, blinded to the study protocol. A computer program will be used to 
perform the randomization (https://www.graphpad.com/quickcalcs/randomize1.cfm). Both 
groups will receive 4 weeks of supervised training with a frequency of three times a week, 
with an approximate duration of 60 minutes each session. Figure 1 presents the flowchart 
with the experimental design of the study. 
 
Blinding (masking) 
Outcome assessments before and after the intervention will be performed by a physical 
therapist blinded to the allocation of participants in each group. 
 
Data collection 
Standardized forms will be used to record pre- and post-intervention evaluations. The registry 
will consider demographic data, social and health habits, clinical variables: comorbidities, 
blood pressure, body mass index (weight, height), type of gynecological cancer, cancer 
staging and type of oncological treatment. In addition, the dosage of the kinesthetic 
intervention will be recorded according to the Borg scale for each session. 
 
Data management 
All study information will be securely stored in the Clinical Research Laboratory, 
Department of Kinesiology, Universidad Católica del Maule, Chile, in locked cabinets. The 
information of each patient will be classified by means of numerical codes and will be kept 
5 years after the end of the investigation in closed filing cabinets. Access to the information 
will be limited to people outside the research team of this study. 
 
Statistical Analysis 
Statistical analysis will be performed using a statistical package SPSS (version 17.0). The 
data will be expressed as mean, standard deviation (SD), lower and upper limit of the 
confidence interval (CI, 95%) or median, minimum, maximum, first and third quartile, 
according to normality distribution using the Kolmogorov Smirnov test. To assess fatigue, 
symptoms of urinary incontinence, sexual function and quality of life, a two-way mixed 
analysis (two-way ANOVA) will be performed, considering time (pre-intervention and post-
intervention) as an intra-subject and group factor as a between-subjects factor. The 
significance level will be set at .05 for all statistical analyses. The intragroup effect sizes for 
the aforementioned variables will also be calculated using the Cohen d index. An effect size 
of more than 0.8 will be considered large, approximately 0.5 moderate, and less than 0.2 
small (Cohen,1988). 
Reference: 
Cohen J. Statistical Power Analysis for the Behavioral Sciences. 1988. 1–17 p.