Low Versus High-intensity Exercises in Sarcopenia

March 19, 2023 updated by: Hisham Mohamed Hussein, University of Hail

Influences of High Versus Low-intensity Exercises in Post-COVID-19 Patients With Sarcopenia Secondary to Chronic Kidney Disease: Randomized Controlled Trial

this study aims to compare the effect of high-intensity resistance exercises measured using the 10-repetition maximum versus low-intensity aerobic exercises on muscle performance, physical function and quality of life in chronic kidney patients with sarcopenia who recently recovered from COVID-19 infection

Study Overview

Detailed Description

Sarcopenia is a prevalent chronic disease caused by aging and is characterized by a reduction in muscle strength and mass (Barajas-Galindo et al., 2021), and consequently deterioration in physical function and quality of life (Gil et al., 2021; Tsekoura et al., 2017). Sarcopenia is associated with higher rates of stroke, frailty, (Bikbov et al., 2020; Go et al., 2004; Levin et al., 2013), and mortality (Ali & Kunugi, 2021). Generally, there are numerous causes of sarcopenia, including chronic kidney diseases (CKD) (Souza et al., 2017), environmental factors, inflammatory mediator's activation, physical inactivity, mitochondrial dysfunction, hormonal changes, and loss of neural junctions (Walston, 2012).

Recently, Sarcopenia had great attention, especially among patients with CKD who already suffer from increased catabolism, higher protein wasting, and other metabolic disorders and decreased functional reserve. Additionality, the decline in physical function due to the deterioration of muscle mass, power, and strength could significantly decrease balance and increase the risk of falling in these populations (Moorthi & Avin, 2017).

After the pandemic of COVID-19 and the mandatory quarantine of patients during the recovery period, CKD patients with sarcopenia who were infected with COVID-19 will be forced to assume a more sedentary lifestyle which consequently magnifies all health risks (Gérard et al., 2021; Gil et al., 2021) jeopardize subjects vitality (Morley et al., 2020; Mousa et al., 2021) and increasing prevalence of sarcopenia (Ali & Kunugi, 2021).

Exercise has been proposed as one of the solutions for sarcopenia-associated symptoms. As per a recent systematic review (Barajas-Galindo et al., 2021), resistance exercises alone or with other forms of exercises could be beneficial especially in improving anthropometric parameters and muscle performance. Yet its specific effects on post-COVID-19 CKD patients who have sarcopenia need further investigation.

The aim of this study is to compare the effectiveness of high versus low-intensity exercises on muscle strength, and physical function in post-COVID-19 patients with sarcopenia secondary to CKD.

Study Type

Interventional

Enrollment (Actual)

82

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

30 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Both sexes with age between 50 - 70 years old.
  • CKD stages (3 and 4)
  • Infected by COVID-19 and recovered (1 - 2 months)
  • Score of 4 or more on SAR-QoL Questionnaire
  • Patients having had a medical prescription for physical rehabilitation.

Exclusion Criteria:

  • Patients infected again by -CoVID-19
  • Any serious inflammatory, neurological, or cardiovascular diseases.
  • Chronic chest disease.
  • Chronic inflammatory orthopedic disorders and rheumatoid arthritis.
  • Mental impairments.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: High intensity exercises
The first group (HG) received a High-intensity exercise program consisting of progressive resistance training for 30 min using dumbbells, sandbags, and TheraBand with different colors. The exercised muscles were (knee extensors, elbow flexors, chest muscles, hip adductors, abductors, abdominal muscles, back muscles, and hand grip muscles) (references). The intensity of exercise was determined by the load which was kept at 65% of the 10-repetition maximum throughout the program duration. The repetitions of each exercise were kept at a fixed value of 2 sets of 10 - 12 repetitions per session (exercises stopped if the patient reached fatigue level). For progression, the 10-repetition maximum test was performed on a weekly schedule and the amount of load was adjusted accordingly. Exercises were done in a cyclic manner where half of the selected muscles were exercised per session and the other half were exercised in the next session.
resistance training progressively increasing according to specific criteria (10 repetitions maximum). for the major muscles of the body
Other Names:
  • progressive resistance training
Experimental: low intensity aerobic exercises
The second group (LG) received a low-intensity aerobic exercise program consisting of an arm ergometer, and a bicycle ergometer to train both upper and lower body muscles. Additionally, 5 minutes of regular treadmill walking was added at the beginning and the end of the exercises session as warming up and cooling down respectively. Exercises were performed in a cyclic manner where the arm and bicycle ergometers were used alternatively. The rate of perceived exertion (RPE) scale was used to monitor the intensity of the exercises to be at 3 -4 level. The actual working out time was 20 minutes plus 10 minutes for the warming up and cooling down. Sessions were performed 3 times per week for six weeks.
low-intensity exercises performed using arm or leg ergometer machines
Other Names:
  • aerobic exercises

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Quality of life (SAR QoL) questionnaire used to assess the quality of life experienced by sarcopenia patients
Time Frame: 6 weeks
In order to measure the quality of life, we used the SarQoL® questionnaire, which is a valid, consistent, and reliable, and can therefore be recommended for clinical and research purposes (Beaudart et al., 2017).
6 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Physical function:
Time Frame: 6 weeks
Modified Physical Performance Test (MPPT) was used to assess basic and complex functional abilities Activities of Daily Living (ADL) with varying difficulty levels. During the test, nine standardized tasks are performed (including walking 15.2 meters, doing a 360° turn, putting on a coat, picking up a coin, rising from a chair, lifting a book, climbing stairs in 2 variations, and picking up a coin). (Brown et al., 2000)
6 weeks
Muscle power:
Time Frame: 6 weeks
(STS- 60): Muscle physical performance is better represented by STS tests than muscle strength. The test used determines which subsets of the population are at risk for sarcopenia. This test measures patient exercise capacity and leg muscle strength. As fast as patient can within a minute, stand up from the chair with his legs straight and sit back down (Bohannon & Crouch, 2019; Yee et al., 2021)
6 weeks
Muscle strength
Time Frame: 6 weeks
isometric hand-grip strength was performed using the JAMAR hand dynamometer (Sammons Preston Rolyan, Bolingbrook, Illinois) were used to measure hand-grip strength of the dominant hand. The participants were seated with their elbows flexed at 90° and their trunks resting. Individual grip sizes were adjusted. Two attempts were conducted, and the averaged values was recorded (Huang et al., 2022; Stoever et al., 2018).
6 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 15, 2023

Primary Completion (Actual)

March 15, 2023

Study Completion (Actual)

March 19, 2023

Study Registration Dates

First Submitted

October 20, 2022

First Submitted That Met QC Criteria

October 20, 2022

First Posted (Actual)

October 25, 2022

Study Record Updates

Last Update Posted (Actual)

March 21, 2023

Last Update Submitted That Met QC Criteria

March 19, 2023

Last Verified

March 1, 2023

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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