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Completed

NCT Number: NCT05593471

Low Versus High-intensity Exercises in Sarcopenia

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

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Key information

Conditions

Sarcopenia Atrophy Muscular Atrophy Nervous System Diseases Neurologic Manifestations Neuromuscular Manifestations Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

30 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

King Khalid Hospital

Ha'il, Saudi Arabia

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

High Intensity Exercises

Other

resistance training progressively increasing according to specific criteria (10 repetitions maximum). for the major muscles of the body

Other names: progressive resistance training

low intensity aerobic exercises

Other

low-intensity exercises performed using arm or leg ergometer machines

Other names: aerobic exercises

Primary outcomes

  1. 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).

Secondary outcomes

  1. 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)

  2. 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)

  3. 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).

Sponsors and collaborators

Lead sponsor

University of Hail

Other

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2023
Study completion
2023
First posted
Oct 25, 2022
Registry last updated
Mar 21, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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