Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT06073691 |
| Other study ID # |
IPq-HCFMUSP |
| Secondary ID |
|
| Status |
Completed |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
July 1, 2015 |
| Est. completion date |
December 1, 2016 |
Study information
| Verified date |
September 2023 |
| Source |
University of Sao Paulo General Hospital |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
The goal of this clinical trial is to test action exercises in the treatment of people with a
diagnosis of Panic disorders with or without agoraphobia.
The main question it aims to answer is:
To investigate the feasibility and effectiveness of a Panic Disorder (PD) treatment protocol
based on anaerobic exercise as an interoceptive exposure therapy.
Participants will The participants were randomly allocated to a 12-week program of either
Intermittent Anaerobic Exercise.
Researchers will compare two groups, one with treatment through an intermittent aerobic
exercise (IAE) protocol and the other group with treatment via a muscle relaxation protocol
(RT), to see if there is feasibility and efficacy of a Panic Disorder treatment protocol
based on anaerobic exercise as exposure therapy, compared to a relaxation activity.
Description:
Study design
The present study compared the effectiveness of two interventions for the treatment of PD:
1. Intermittent Anaerobic Exercise (IAE), performed as a regular and controlled systematic
physical exercise of running and walking to provide Interoceptive Exposure (IE);
2. Jacobson's Progressive Muscle Relaxation method (RT). The study was designed as a
prospective, two-arm, blinded, randomized, controlled clinical trial. Patients and
assessors were informed that participants could receive an active pharmacological
treatment or a matching placebo; however, all patients received only a placebo. The
study was carried out at the Anxiety Disorders Program of the Institute of Psychiatry
and the Institute of Orthopedics and Traumatology of the Faculty of Medicine of the
University of São Paulo, São Paulo, Brazil.
Subjects The subjects were referred for treatment to the Anxiety Disorder Program at the
emergency room (PS) of the Heart Institute (InCor). After clinical interviews of 121 suitable
individuals, it was discovered that 102 met the pre-established inclusion criteria.
Participants were randomly allocated a Microsoft Excel spreadsheet to a 12-week program of
IAE (n = 51) or RT (n = 51). Seventy-two patients completed the study, 38 women (52.8%) and
34 men (47.2%), aged between 21 and 51 years (mean: 33.3 ± 7.7 years). Among them, 22 (30.6%)
were smokers. The mean age of onset of panic attacks was 28.3 ± 4.5 years. These groups were
not significantly different in terms of sociodemographic characteristics.
Cardiovascular status assessments Initially, the subjects performed an exercise test on a
medical treadmill at different speeds and inclines. As a subjective criterion, the Borg
Rating of Perceived Exertion (RPE) scale was used in all tests paired with exercise intensity
monitoring. However, in patients with PD, a simple assessment of subjective perception of
exertion, such as the Borg RPE scale, may be insufficient to accurately capture the intensity
of physical exertion. Before the test, the Physical Activity Readiness Questionnaire (PAR-Q)
was used for cardiovascular risk, although the Heck test protocol presents a minimal risk of
cardiac events (1/10,000-1/20,000).
Outcome evaluations The study evaluator was a trained psychiatrist with experience in using
the MINI questionnaire and the rating scales used in this project. He was unaware of the
patient's allocation and performed all assessments. All patients were evaluated at
presentation (week -2), at baseline (week 0), and at weeks 6, 12, and 24 follow-up assessment
(FU). Intervention programs were carried out weekly from week 0 to week 12.
The activities began with a short stretching session, and a warm-up, following the
specificity of the exercise, of approximately 5 minutes at 55% of the individual's Maximum
Heart Rate (Fcmax), previously stipulated by the exercise test (Ergospirometry).
After warming up, the patient walked for 15 minutes at 65% Fcmax. followed by a 30-second run
at 85% Fcmax, returning to an active recovery of another 15 minutes of walking at 65% Fcmax,
followed by another 5 minutes at 55% Fcmax, finishing with a stretch specific.
All participants had their heart rates monitored by a heart rate monitor. The time of
anaerobic activity was gradually increased as a way of training this capacity and as a
motivating factor for exercise.
The relaxation activities were led by a psychologist collaborating with the project. Three
weekly sessions lasting 45 minutes were held. for three months. Relaxation followed criteria
based on Progressive Muscle Relaxation Techniques.
The Jacobson technique can reduce or nullify the muscle tension found in anxious moments. The
technique offers an easy way to identify muscles in tension and their relaxation, as most
patients do not realize that the muscles are in tension.
The patient is placed in the supine position. Contract each muscle group or isolated muscle
for 5 to 7 seconds and then relax for 20 to 30 seconds. The sequence is performed once, but
when the region remains tense, the sequence is repeated up to 5 times. When relaxing, some
verbal instructions were introduced to help with this, such as "throw away the tension",
"feel calm and rested", "relax and soften your muscles" and "let the tension dissolve". The
most important thing in the process was to make the patient notice the difference between
muscle contraction and relaxation.
Primary outcome measure:
Changes in PD severity scores were assessed using the Panic Agoraphobia Scale (PAS), a
13-item measure of PD symptoms; Observer-rated and self-reported versions were used in the
present study. The items assessed were panic attacks, agoraphobic avoidance, anticipatory
anxiety, disability, functional impairment, and health concerns. The assessor was fluent in
Portuguese and English and had copies of the assessed and self-reported PAS versions. The
Portuguese version of the scale was translated from English by one of the authors during the
scale development phase in agreement with the author.
Secondary outcome measures:
1. Frequency and intensity of panic attacks, measured through a panic attack registry;
2. Severity of general anxiety symptoms, assessed by the Hamilton Anxiety Rating Scale
(HAM-A);
3. Severity of depressive symptoms, assessed by the Hamilton Rating Scale for Depression
(HAM-D).
Successful response to treatment was defined as a ≥ 50% reduction from baseline scores on
both Hamilton scales.
Data analysis Pearson's chi-square test was used to analyze the distribution of categorical
variables. The Shapiro-Wilk test and other distribution exploration techniques were used to
assess whether the continuous variables followed a normal distribution. The Mann-Whitney-U
test was used to compare continuous variables between intervention groups. Two-way
repeated-measures ANOVA and post-hoc analysis for pairwise comparisons with Holm's correction
were used to evaluate between- and within-group differences over time.
The sample size needed for 95% power was estimated to be 36 subjects per group using G*Power
software v. 3.1.9.6 (available from the University of Dusseldorf). The data were analyzed and
processed using Jamovi software v. 2.2.5. A significance level of 5% was considered in all
analyses.
