SarcopeniaNCT05593471
Low Versus High-intensity Exercises in Sarcopenia
A study testing high intensity exercises and low intensity aerobic exercises in people with Sarcopenia, run by University of Hail at 1 site in Saudi Arabia.
Trial summary
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 Read more about this study
- Who is it for?
- Ages 30 to 70 years
- Conditions the study is for
- Sarcopenia
- What is being tested?
- high intensity exercises and low intensity aerobic exercises
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 82 participants
- Where
- 1 siteSaudi Arabia
- Study dates
- 15 Jan 2023to 19 Mar 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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
Read the 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.
- Conditions
- Sarcopenia
- Being tested
- high intensity exercises, low intensity aerobic exercises
- Medical subject headings
- Sarcopenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
high intensity exercisesOther
Also called progressive resistance training
resistance training progressively increasing according to specific criteria (10 repetitions maximum). for the major muscles of the body
low intensity aerobic exercisesOther
Also called aerobic exercises
low-intensity exercises performed using arm or leg ergometer machines
| Study group | Role | What they receive |
|---|---|---|
| High intensity exercises | Experimental | 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. Receives: Other: high intensity exercises |
| low intensity aerobic exercises | Experimental | 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. Receives: Other: low intensity aerobic exercises |
What is being measured
The primary outcome is the main question the study is designed to answer.
Quality of life (SAR QoL) questionnaire used to assess the quality of life experienced by sarcopenia patients
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).
Measured: 6 weeks
Secondary outcomes (3)
Physical function:
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)
Measured: 6 weeks
Muscle power:
(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)
Measured: 6 weeks
Muscle strength
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).
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Oct 2022
- Study start15 Jan 2023
- Primary completion15 Mar 2023
- Study completion19 Mar 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SarcopeniaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 82 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Hail
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hisham Mohamed Hussein, University of Hail
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05593471
- Sponsor's protocol ID
- SCR-22029
- Status last verified
- Mar 2023
- First submitted
- 20 Oct 2022
- Last updated
- 21 Mar 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Influences of High Versus Low-intensity Exercises in Post-COVID-19 Patients With Sarcopenia Secondary to Chronic Kidney Disease: Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT05593471
- Acronym / sponsor ID
- SCR-22029
- Conditions
- Sarcopenia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 82 participants (actual)
- Lead sponsor
- University of HailUniversity, hospital or other
- Study start
- 15 Jan 2023 (actual)
- Primary completion
- 15 Mar 2023 (actual)
- Study completion
- 19 Mar 2023 (actual)
- First posted
- 25 Oct 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| High intensity exercises | Experimental | Other: high intensity exercisesThe 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. |
| low intensity aerobic exercises | Experimental | Other: low intensity aerobic exercisesThe 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. |
Who may qualify
- Ages
- 30 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| high intensity exercisesAlso: progressive resistance trainingresistance training progressively increasing according to specific criteria (10 repetitions maximum). for the major muscles of the body | Other | High intensity exercises |
| low intensity aerobic exercisesAlso: aerobic exerciseslow-intensity exercises performed using arm or leg ergometer machines | Other | low intensity aerobic exercises |
Primary outcome
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).
3 secondary outcomes
Physical function:
Time frame: 6 weeks
Muscle power:
Time frame: 6 weeks
Muscle strength
Time frame: 6 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Mar 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing high intensity exercises and low intensity aerobic exercises in people with Sarcopenia, run by University of Hail at 1 site in Saudi Arabia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Saudi Arabia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Quality of life (SAR QoL) questionnaire used to assess the quality of life experienced by sarcopenia patients (time frame: 6 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Mar 2023.