Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Chronic kidney disease (CKD) is a progressive clinical condition that affects a growing number of people worldwide. While advances in haemodialysis techniques have led to notable improvements in survival rates and the quality of life (QoL) of patients with CKD (PwCKD), significant complications persist, primarily associated with chronic uremia. These include skeletal muscle atrophy, reduced muscular strength and diminished functional capacity.
Recent studies support the role of systematic exercise as a non-pharmacological strategy to reduce issues and improve musculoskeletal function among haemodialysis patients. Specifically, intradialytic exercise gained ground due to its efficiency in time utilization and elimination of transport burden. Nevertheless, most of the intradialytic exercise programs implement aerobic exercise and there is a lack of studies investigating combined strength and aerobic exercise modalities, which may offer more comprehensive physiological benefits.
The aim of the randomized controlled trial (RCT) is to examine whether a 6-month combined aerobic and resistance exercise program, implemented during haemodialysis sessions, could affect body composition, muscle oxygenation of the lower and upper extremities, and functional capacity of patients that underwent haemodialysis.
Forty patients will be randomly allocated into two groups: Group A (Exercise Group) will undergo 3 sessions per week of an intradialytic exercise program for 6 months and Group B (Control Group) will receive the usual care without participating in organized exercise programs.
Prior to the group random allocation, part of our assessments at baseline and after 6 (Evaluation A') will include demographics and clinical history, body composition analysis via bioelectrical impedance analysis, muscle oxygenation monitoring of the vastus lateralis and biceps brachii muscles at rest and during exercise using near-infrated spectroscopy (NIRS) technology. Functional capacity will be assessed through validated tests: Six-minute walk test (6MWT), 30-second sit-to-stand test, five-repetition sit-to-stand test (5STS), handgrip strength, 4-meter gait speed test. Additionally, we will use questionnaires assessing physical activity using International Physical Activity Questionnaire (IPAQ), depression using Beck Depression Inventory (BDI), stress using Generalized Anxiety Disorder 7-item scale(GAD-7) and the QoL using Kidney Disease Quality of Life Short Form(KDQOL-SF) of people that underwent dialysis.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Exercise | Experimental | Exercise Group, 6- month combined aerobic and strength exercise |
|
| Usual care | No Intervention | Control Group, 6- month without participating in organized exercise activities, no intervention |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| EXERCISE INTERVENTION | Other | Patients randomly assigned to this group will be invited to attend a 6 month exercise program. The 6-month exercise intervention will be conducted three times per week during the first two hours of each hemodialysis session at the 2nd Nephrology Clinic at AHEPA University Hospital. Each session will begin with a warm-up phase, followed by aerobic exercise using bedside-adapted cycle ergometers. Exercise duration will initially be set at 30 minutes and progressively increased to 60 minutes, performed at moderate intensity (12-13 on the 6-20 Borg Rating of Perceived Exertion scale). After the first month, resistance training will be gradually introduced, initially using body weight and subsequently incorporating elastic resistance bands. Each session will conclude with a cool-down period. |
| Measure | Description | Time Frame |
|---|---|---|
| Clinical and demographic characteristics | Baseline | |
| Clinical and demographic characteristics | 6-month | |
| Muscle oxygenation Assessment-MOXY | Measurement of vastus lateralis and biceps brachii muscle oxygenation at rest and during exercise using near-infrared spectroscopy (NIRS) devices (Moxy 1408, Fortiori Design LLC, Minnesota, USA; Moxy 2136, Idiag AG, Fehraltorf, Switzerland). | Baseline |
| Muscle oxygenation Assessment-MOXY | Measurement of vastus lateralis and biceps brachii muscle oxygenation at rest and during exercise using near-infrared spectroscopy (NIRS) devices (Moxy 1408, Fortiori Design LLC, Minnesota, USA; Moxy 2136, Idiag AG, Fehraltorf, Switzerland). | 6-month |
| Body composition analysis | Bioelectrical impedance analysis (Bodystat QuadScan 4000). | Baseline |
| Body composition analysis | Bioelectrical impedance analysis (Bodystat QuadScan 4000). | 6-month |
| Six minute walk test | Aerobic capacity | Baseline |
| Six minute walk test | Aerobic capacity | 6-month |
Not provided
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Evangelia Kouidi, Professor | Sports Medicine Laboratory, School of Physical Education and Sports Science, Aristotle University of Thessaloniki, Greece | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sports Medicine Laboratory, Aristotle University of Thessaloniki | Thessaloniki | 57001 | Greece |
Not provided
Not provided
Not provided
Not provided
Not provided
|
| JAMAR SMART Hand Dynamometer | Handgrip Strength | Baseline |
| JAMAR SMART Hand Dynamometer | Handgrip Strength | 6- month |
| 30-second Sit-to-Stand Test | Lower limb functional capacity | Baseline |
| 30-second Sit-to-Stand Test | Lower limb functional capacity | 6- month |
| Five-Repetition Sit-to-Stand Test (5STS) | Lower limb functional capacity | Baseline |
| Five-Repetition Sit-to-Stand Test (5STS) | Lower limb functional capacity | 6- month |
| 4-Meter Gait Speed Test | Baseline |
| 4-Meter Gait Speed Test | 6- month |
| International Physical Activity Questionnaire (IPAQ). | Assessment of Physical Activity (PA) Levels (MET-min/week). Using the IPAQ scoring protocol, participants classified into three PA categories: low (<600 MET-min/week), moderate, and high (active) (≥3000 MET-min/week or vigorous PA ≥1500 MET-min/week). Higher scores indicate more physically active patients. | Baseline |
| International Physical Activity Questionnaire (IPAQ). | Assessment of Physical Activity (PA) Levels (MET-min/week). Using the IPAQ scoring protocol, participants classified into three PA categories: low (<600 MET-min/week), moderate, and high (active) (≥3000 MET-min/week or vigorous PA ≥1500 MET-min/week). Higher scores indicate more physically active patients. | 6- month |
| Beck Depression Inventory (BDI) | Assessment of depressive symptoms. Total score ranges from 0 to 63. Each item is scored 0-3, where higher scores indicate more severe symptoms. Typical interpretations are: 0-13 (minimal), 14-19 (mild), 20-28 (moderate), and 29-63 (severe). | Baseline |
| Beck Depression Inventory (BDI) | Assessment of depressive symptoms. Total score ranges from 0 to 63. Each item is scored 0-3, where higher scores indicate more severe symptoms. Typical interpretations are: 0-13 (minimal), 14-19 (mild), 20-28 (moderate), and 29-63 (severe). | 6- month |
| Generalized Anxiety Disorder-7 scale (GAD-7). | Assessment of anxiety symptoms. The Generalized Anxiety Disorder-7 scale (GAD-7) is a 7-item self-report questionnaire assessing anxiety symptoms over the past 2 weeks, with a total score range of 0-21 (items scored 0-3). Severity categories are 0-4 minimal, 5-9 mild, 10-14 moderate, and 15-21 severe; Higher scores indicate more severe anxiety symptoms. | Baseline |
| Generalized Anxiety Disorder-7 scale (GAD-7). | Assessment of anxiety symptoms. The Generalized Anxiety Disorder-7 scale (GAD-7) is a 7-item self-report questionnaire assessing anxiety symptoms over the past 2 weeks, with a total score range of 0-21 (items scored 0-3). Severity categories are 0-4 minimal, 5-9 mild, 10-14 moderate, and 15-21 severe; Higher scores indicate more severe anxiety symptoms. | 6- month |
| Kidney Disease Quality of Life Short Form (KDQOL-SF™) | Assessment of health-related quality of life. The Kidney Disease Quality of Life Short Form (KDQOL-SF™) assesses kidney disease-specific and general health. Domain scores range from 0-100 scale (minimum 0; maximum 100). Higher scores indicate better quality of life. | Baseline |
| Kidney Disease Quality of Life Short Form (KDQOL-SF™) | Assessment of health-related quality of life. The Kidney Disease Quality of Life Short Form (KDQOL-SF™) assesses kidney disease-specific and general health. Domain scores range from 0-100 scale (minimum 0; maximum 100). Higher scores indicate better quality of life. | 6- month |
| Baseline leg dynamometer | Baseline |
| Baseline leg dynamometer | 6- month |
| ID | Term |
|---|---|
| D051436 | Renal Insufficiency, Chronic |
| ID | Term |
|---|---|
| D051437 | Renal Insufficiency |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
Not provided
Not provided