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Low Versus High-intensity Exercises in Sarcopenia

Primary Purpose

Sarcopenia

Status
Completed
Phase
Not Applicable
Locations
Saudi Arabia
Study Type
Interventional
Intervention
high intensity exercises
low intensity aerobic exercises
Sponsored by
University of Hail
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Sarcopenia

Eligibility Criteria

30 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • King Khalid Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

High intensity exercises

low intensity aerobic exercises

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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).

Secondary Outcome Measures

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)
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)
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).

Full Information

First Posted
October 20, 2022
Last Updated
March 19, 2023
Sponsor
University of Hail
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1. Study Identification

Unique Protocol Identification Number
NCT05593471
Brief Title
Low Versus High-intensity Exercises in Sarcopenia
Official Title
Influences of High Versus Low-intensity Exercises in Post-COVID-19 Patients With Sarcopenia Secondary to Chronic Kidney Disease: Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Completed
Study Start Date
January 15, 2023 (Actual)
Primary Completion Date
March 15, 2023 (Actual)
Study Completion Date
March 19, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Hail

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief 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
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sarcopenia

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
82 (Actual)

8. Arms, Groups, and Interventions

Arm Title
High intensity exercises
Arm Type
Experimental
Arm Description
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.
Arm Title
low intensity aerobic exercises
Arm Type
Experimental
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
high intensity exercises
Other Intervention Name(s)
progressive resistance training
Intervention Description
resistance training progressively increasing according to specific criteria (10 repetitions maximum). for the major muscles of the body
Intervention Type
Other
Intervention Name(s)
low intensity aerobic exercises
Other Intervention Name(s)
aerobic exercises
Intervention Description
low-intensity exercises performed using arm or leg ergometer machines
Primary Outcome Measure Information:
Title
Quality of life (SAR QoL) questionnaire used to assess the quality of life experienced by sarcopenia patients
Description
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).
Time Frame
6 weeks
Secondary Outcome Measure Information:
Title
Physical function:
Description
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)
Time Frame
6 weeks
Title
Muscle power:
Description
(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)
Time Frame
6 weeks
Title
Muscle strength
Description
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).
Time Frame
6 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Facility Information:
Facility Name
King Khalid Hospital
City
Hail
Country
Saudi Arabia

12. IPD Sharing Statement

Plan to Share IPD
No

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Low Versus High-intensity Exercises in Sarcopenia

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