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临床试验/NCT07651371
NCT07651371已完成不适用

Clinical, Functional, and Laboratory Outcomes of a Physical Rehabilitation Program for the Treatment of Long COVID: A Non-Controlled Clinical Trial

Universidade do Estado do Pará1 个研究点 分布在 1 个国家目标入组 74 人开始时间: 2021年1月5日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
74
试验地点
1
主要终点
hand grip strength

研究概览

简要总结

The objective of this clinical trial is to analyze the clinical, functional, and laboratory effects of a rehabilitation protocol designed for patients with long COVID; it may include any of the following: sex/gender, age groups, healthy volunteers. The main questions it aims to answer are:

Does handgrip strength improve after the intervention? Does the 6-minute walk test improve after the intervention? Participants must attend all 20 sessions of the physical rehabilitation program.

详细描述

The objective is to analyze the clinical, functional, and laboratory effects of a rehabilitation protocol aimed at patients with long COVID. This is an experimental analytical study of the uncontrolled clinical trial type conducted in accordance with the TREND recommendation. The present study was conducted at the Cardiorespiratory Diseases Outpatient Clinic (UEAFTO/UEPA). The Cardiorespiratory Diseases Outpatient Clinic is located at UEAFTO, part of UEPA, in the city of Belém. The clinic integrates teaching, research, and outreach activities and serves as a reference center for the clinical and multidisciplinary care of patients with cardiorespiratory diseases, including infectious diseases, referred from the state public health system. Clinical muscle and functional assessments were performed at this facility.

The collection and analysis of biological material (blood samples) were performed at the Clinical Analysis and Cytopathology Laboratory (LAC), located at UEPA, in the city of Belém, within the Center for Biological Health Sciences (CCBS), which performs various laboratory tests, contributing to scientific knowledge through collaborative studies and projects with the institution's academic community.

The multidisciplinary rehabilitation program consisted of 20 in-person sessions, each lasting 50 minutes, divided into four phases of progressive load. All sessions were structured in three stages: warm-up, training proper, and cool-down. The warm-up consisted of 10 minutes of stretching exercises. During the training stage (30 minutes), participants walked on a treadmill for 15 minutes, with intensity controlled by reserve heart rate (HR), progressing from 50% (sessions 1-5) to 60% (6-10), 70% (11-15), and reaching 80% in the final sessions (16-20). Respiratory muscle training (RMT) was performed with an initial load of 25% of Maximum Inspiratory Pressure (MIP), progressing to 30% starting from the 11th session, with variations in volume ranging from 3 sets of 12 repetitions to 4 sets of 15 repetitions throughout the phases. Resistance training for the upper limbs (vertical bench press and front pull) and lower limbs (leg extension machine and 180° leg press) followed a load progression from 55% to 70% of one-repetition maximum (1 RM), with a gradual increase in the number of repetitions (10 to 15). Finally, the cool-down consisted of 10 minutes of seated rest, incorporating diaphragmatic awareness exercises for metabolic and respiratory recovery.

The primary outcomes were changes in handgrip strength (HGS) and the 6-minute walk test (6MWT) from the 1st to the 20th visit. Secondary outcomes included changes in the functional status scale score, pain tolerance threshold (pressure algometry), and percentage of muscle mass and fat mass (bioimpedance), assessed at the beginning and end of the 20 visits. At the initial assessment, sociodemographic data such as sex, age in years, place of birth, education, marital status, and income in minimum wages were collected.

Hand Dynamometry Handgrip Strength (HGS) was assessed using a CROW model hydraulic hand dynamometer. The test was performed according to the recommendations of the American Society of Hand Therapists (ASTH). The participant was asked to perform a maximum contraction for three seconds for each hand.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Treatment
盲法
None

入排标准

年龄范围
18 Years 至 70 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • patients of both sexes,
  • aged 18 years or older,
  • diagnosed with long COVID;

排除标准

  • pregnant women,
  • individuals with special needs,
  • patients who refuse to sign the informed consent form.

研究组 & 干预措施

treatment

Experimental

Before-and-after treatment

干预措施: Physical rehabilitation (Other)

treatment

Experimental

Before-and-after treatment

干预措施: Treadmill ergometer (Device)

treatment

Experimental

Before-and-after treatment

干预措施: Pulley (Device)

结局指标

主要结局

hand grip strength

时间窗: Through the end of the 20 sessions (up to 10 weeks)

Handgrip strength (HGS) was measured using a CROW model manual hydraulic dynamometer. The test was conducted in accordance with the recommendations of the American Society of Hand Therapists (ASTH).

次要结局

未报告次要终点

研究者

发起方
Universidade do Estado do Pará
申办方类型
Other
责任方
Principal Investigator
主要研究者

Luiz Fábio Magno Falcão, PhD

Clinical Professor

Universidade do Estado do Pará

研究点 (1)

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