Effectiveness of Aquatic Exercise on Fatigue, Neuropathy and Quality of Life Among Cancer Patients

Study Overview
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Brief Summary
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The majority of cancer patients experience exhaustion, fatigue, and neuropathy that impact their participation in daily activities and reduce their quality of life. In addition, they may affect the ability to function at work and delay a return to employment. Studies have demonstrated that physical activity has a positive effect and consequently, patients being treated for cancer are advised to avoid inactivity. Various studies have described Tai Chi practice as beneficial in reducing exhaustion and fatigue to some extent, and have suggested that it may improve the quality of life of cancer patients. The environment in which physical activity takes place is also important. The properties of water and their effect on the submerged human body may be particularly beneficial for cancer patients. A previous study among breast cancer patients reported that exercise in deep water significantly reduced exhaustion and fatigue compared to patients who received only regular treatment. The practice of Tai Chi in water is termed Ai Chi. The objectives of the present study are to examine the effects of an Ai Chi program as compared to an intervention group undergoing identical physical exercise on land, and a third group with no additional exercise in cancer patients on:(A)time to return to work, work hours, perception of work-related difficulties, and work absenteeism;(B)activity and participation in the daily life and quality of life; and(C)exhaustion, fatigue, and neuropathy. This is a randomized clinical trial. 150 cancer patients aged 18-65 years will be recruited. Subjects who meet the recruitment criteria will be randomly divided into one of three groups:(a)Water exercise (Ai Chi);(b)Identical land exercise; and(c)Control-who will not perform additional physical activity or receive any extra treatments. The exercise program will be scheduled for 30 minutes twice a week for 8 weeks. Research tools include:(1)WHODAS 2.0;(2)EORTC QLQ-C30; (3)Piper Fatigue Scale;(4) Employment Barriers Questionnaire;(5) Neuropathy Questionnaire (EORTCOLO QLQ-CIPN20);and(6)Date of return to work and duration of working hours - self-report by the study participants. Data will be collected before the intervention, after 8 weeks of intervention, and then at 3, 12, and 24 months from the end of the intervention. The investigators will perform a series of mixed variance analyzes to identify relationships and associations between groups and with time within a group (independent variables).

Official Title
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Effectiveness of Cancer Patients' Aquatic Exercise Program for Cancer-related Fatigue, Cancer-related Neuropathy, Activity and Participation, Quality of Life and Return to Work: A Randomized Controlled Trial

Conditions
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Colon Cancer, Breast Cancer

Intervention / Treatment
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* Other: Water exercise group
* Other: Land exercise group
* Other: Control group


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Diagnosis of cancer (stage 3 colon cancer patients and breast cancer patients with lymph node involvement). recruitment of colorectal cancer patients and breast cancer patients for the study will be within 3 months of cessation of chemotherapy treatment. a score above 26 on the cognitive MOCA test. Exclusion Criteria: Volunteers with orthopedic disabilities / injuries that in the opinion of the attending physician prevent their participation in physical exercise Volunteers engaged in other physical activity on a regular basis

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Water exercise group<br>Water exercise group where the Ai Chi technique was selected as the exercise method of choice. The activity will take place in a hydrotherapy pool approved by the Ministry of Health and will be led by a hydrotherapist who has been trained in Ai Chi | Other: Water exercise group<br>* Water exercise group where the Ai Chi technique was selected as the exercise method of choice. The activity will take place in a hydrotherapy pool approved by the Ministry of Health and will be led by a hydrotherapist who has been trained in Ai Chi.<br>|
| Experimental: Land exercise group<br>Land exercise group who will perform the same Ai Chi movements on land in order to standardize the groups. The activity will take place in a hall and will be led by a physiotherapist who has been trained to teach Ai Chi on land | Other: Land exercise group<br>* Land exercise group who will perform the same Ai Chi movements on land in order to standardize the groups. The activity will take place in a hall and will be led by a physiotherapist who has been trained to teach Ai Chi on land.<br>|
| Experimental: Control group<br>Control group who will not perform additional physical activity or receive any extra treatments | Other: Control group<br>* Control group who will not perform additional physical activity or receive any extra treatments.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in degree of activity and participation before the start of the intervention (at baseline) and 8 weeks of intervention | WHODAS 2.0 is a self-report questionnaire that captures the level of functioning in six domains of life: Cognition - understanding and communicating, Mobility - moving and getting around, Self-care - attending to one's hygiene, dressing, eating and staying alone, Getting along - interacting with other people, Life activities - domestic responsibilities, leisure, work and school, Participation - joining in community activities, participating in society. The average scores are comparable to the WHODAS 5-point scale, which allows the clinician to think of the individual's disability in terms of none (0-0.49), mild (0.5-1.49), moderate (1.5-2.49), severe (2.5-3.49), or extreme (3.5-4). The average domain score is calculated by dividing the raw domain score by the number of items in the domain. The average general disability score is calculated by dividing the raw overall score by number of items in the measure (36). The scoring method is used for each of the 6 domains | Data will be collected before the start of the intervention (at baseline) and 8 weeks of intervention | 
| Changes in degree of activity and participation before the start of the intervention (at baseline) and 3 months from the end of the intervention. | WHODAS 2.0 is a self-report questionnaire that captures the level of functioning in six domains of life: Cognition - understanding and communicating, Mobility - moving and getting around, Self-care - attending to one's hygiene, dressing, eating and staying alone, Getting along - interacting with other people, Life activities - domestic responsibilities, leisure, work and school, Participation - joining in community activities, participating in society. The average scores are comparable to the WHODAS 5-point scale, which allows the clinician to think of the individual's disability in terms of none (0-0.49), mild (0.5-1.49), moderate (1.5-2.49), severe (2.5-3.49), or extreme (3.5-4). The average domain score is calculated by dividing the raw domain score by the number of items in the domain. The average general disability score is calculated by dividing the raw overall score by number of items in the measure (36). The scoring method is used for each of the 6 domains | Data will be collected before the start of the intervention (at baseline) and 3 months from the end of the intervention | 
| Changes in degree of activity and participation, before the start of the intervention (at baseline), and 12 months from the end of the intervention. | WHODAS 2.0 is a self-report questionnaire that captures the level of functioning in six domains of life: Cognition - understanding and communicating, Mobility - moving and getting around, Self-care - attending to one's hygiene, dressing, eating and staying alone, Getting along - interacting with other people, Life activities - domestic responsibilities, leisure, work and school, Participation - joining in community activities, participating in society. The average scores are comparable to the WHODAS 5-point scale, which allows the clinician to think of the individual's disability in terms of none (0-0.49), mild (0.5-1.49), moderate (1.5-2.49), severe (2.5-3.49), or extreme (3.5-4). The average domain score is calculated by dividing the raw domain score by the number of items in the domain. The average general disability score is calculated by dividing the raw overall score by number of items in the measure (36). The scoring method is used for each of the 6 domains | Data will be collected before the start of the intervention (at baseline), and 12, months from the end of the intervention. | 
| Changes in degree of activity and participation before the start of the intervention (at baseline) and 24 months from the end of the intervention. | WHODAS 2.0 is a self-report questionnaire that captures the level of functioning in six domains of life: Cognition - understanding and communicating, Mobility - moving and getting around, Self-care - attending to one's hygiene, dressing, eating and staying alone, Getting along - interacting with other people, Life activities - domestic responsibilities, leisure, work and school, Participation - joining in community activities, participating in society. The average scores are comparable to the WHODAS 5-point scale, which allows the clinician to think of the individual's disability in terms of none (0-0.49), mild (0.5-1.49), moderate (1.5-2.49), severe (2.5-3.49), or extreme (3.5-4). The average domain score is calculated by dividing the raw domain score by the number of items in the domain. The average general disability score is calculated by dividing the raw overall score by number of items in the measure (36). The scoring method is used for each of the 6 domains | Data will be collected before the start of the intervention (at baseline) and 24 months from the end of the intervention. | 
| Changes in Quality of life before the start of the intervention (at baseline) and 8 weeks of intervention | The EORTC QLQ-C30 has 30 items arranged into nine scales (dimensions) and six single items. The scales are divided into five function scales (physical, role, cognitive, emotional and social functions); three symptom scales (fatigue, pain, nausea or vomiting) and one global health-status/quality of life dimension. The six single items address specific symptoms: dyspnoea, appetite loss, insomnia, constipation, diarrhoea and a question addressing the financial impact of the disease. Each item has four response alternatives: 1) not at all, 2) a little 3) quite a bit 4) very much except for the global health-status/quality of life scale, which has response options ranging from 1) very poor to 7) excellent. | Data will be collected before the start of the intervention (at baseline) and 8 weeks of intervention | 
| Changes in Quality of life before the start of the intervention (at baseline) and 3 months from the end of the intervention | The EORTC QLQ-C30 has 30 items arranged into nine scales (dimensions) and six single items. The scales are divided into five function scales (physical, role, cognitive, emotional and social functions); three symptom scales (fatigue, pain, nausea or vomiting) and one global health-status/quality of life dimension. The six single items address specific symptoms: dyspnoea, appetite loss, insomnia, constipation, diarrhoea and a question addressing the financial impact of the disease. Each item has four response alternatives: 1) not at all, 2) a little 3) quite a bit 4) very much except for the global health-status/quality of life scale, which has response options ranging from 1) very poor to 7) excellent. | Data will be collected before the start of the intervention (at baseline) and 3 months from the end of the intervention | 
| Changes in Quality of life before the start of the intervention (at baseline) and 12 months from the end of the intervention | The EORTC QLQ-C30 has 30 items arranged into nine scales (dimensions) and six single items. The scales are divided into five function scales (physical, role, cognitive, emotional and social functions); three symptom scales (fatigue, pain, nausea or vomiting) and one global health-status/quality of life dimension. The six single items address specific symptoms: dyspnoea, appetite loss, insomnia, constipation, diarrhoea and a question addressing the financial impact of the disease. Each item has four response alternatives: 1) not at all, 2) a little 3) quite a bit 4) very much except for the global health-status/quality of life scale, which has response options ranging from 1) very poor to 7) excellent. | Data will be collected before the start of the intervention (at baseline), and 12 months from the end of the intervention. | 
| Changes in Quality of life before the start of the intervention (at baseline) and 24 months from the end of the intervention | The EORTC QLQ-C30 has 30 items arranged into nine scales (dimensions) and six single items. The scales are divided into five function scales (physical, role, cognitive, emotional and social functions); three symptom scales (fatigue, pain, nausea or vomiting) and one global health-status/quality of life dimension. The six single items address specific symptoms: dyspnoea, appetite loss, insomnia, constipation, diarrhoea and a question addressing the financial impact of the disease. Each item has four response alternatives: 1) not at all, 2) a little 3) quite a bit 4) very much except for the global health-status/quality of life scale, which has response options ranging from 1) very poor to 7) excellent. | Data will be collected before the start of the intervention (at baseline), and 24 months from the end of the intervention. | 
| Changes in Exhaustion and fatigue before the start of the intervention (at baseline) and 8 weeks of intervention | Piper Fatigue Scale - to assess the levels of exhaustion and fatigue. It consists of 22 numerical items to assess fatigue at the time of the questionnaire. The items are scored on a 0-10 Likert scale and measure the four dimensions of behavioral/severity (six items), affective meaning (five items), sensory (five items), and cognitive/mood (six items). To calculate the subscale score, the scores of the items on the specific subscales are summed and divided by the number of items in the subscale. All item scores are summed and divided by 22 to calculate the total fatigue score, which has a range from 0 to 10, with a high score indicating a high fatigue level. | Data will be collected before the start of the intervention (at baseline) and 8 weeks of intervention | 
| Changes in Exhaustion and fatigue before the start of the intervention (at baseline) and 3 months from the end of the intervention. | Piper Fatigue Scale - to assess the levels of exhaustion and fatigue. It consists of 22 numerical items to assess fatigue at the time of the questionnaire. The items are scored on a 0-10 Likert scale and measure the four dimensions of behavioral/severity (six items), affective meaning (five items), sensory (five items), and cognitive/mood (six items). To calculate the subscale score, the scores of the items on the specific subscales are summed and divided by the number of items in the subscale. All item scores are summed and divided by 22 to calculate the total fatigue score, which has a range from 0 to 10, with a high score indicating a high fatigue level. | Data will be collected before the start of the intervention (at baseline) and 3 months from the end of the intervention | 
| Changes in Exhaustion and fatigue before the start of the intervention (at baseline) and 12 months from the end of the intervention. | Piper Fatigue Scale - to assess the levels of exhaustion and fatigue. It consists of 22 numerical items to assess fatigue at the time of the questionnaire. The items are scored on a 0-10 Likert scale and measure the four dimensions of behavioral/severity (six items), affective meaning (five items), sensory (five items), and cognitive/mood (six items). To calculate the subscale score, the scores of the items on the specific subscales are summed and divided by the number of items in the subscale. All item scores are summed and divided by 22 to calculate the total fatigue score, which has a range from 0 to 10, with a high score indicating a high fatigue level. | Data will be collected before the start of the intervention (at baseline) and 12 months from the end of the intervention | 
| Changes in Exhaustion and fatigue before the start of the intervention (at baseline) and 24 months from the end of the intervention. | Piper Fatigue Scale - to assess the levels of exhaustion and fatigue. It consists of 22 numerical items to assess fatigue at the time of the questionnaire. The items are scored on a 0-10 Likert scale and measure the four dimensions of behavioral/severity (six items), affective meaning (five items), sensory (five items), and cognitive/mood (six items). To calculate the subscale score, the scores of the items on the specific subscales are summed and divided by the number of items in the subscale. All item scores are summed and divided by 22 to calculate the total fatigue score, which has a range from 0 to 10, with a high score indicating a high fatigue level. | Data will be collected before the start of the intervention (at baseline) and 24 months from the end of the intervention | 
| Changes in Employment before the start of the intervention (at baseline) and 8 weeks of intervention | Employment Barriers Questionnaire. It consists of 77 numerical items to assess workers barriers at the time of the questionnaire. The items are scored on a 0-4 Likert scale and measure the two dimensions of environmental and occupational barriers. | Data will be collected before the start of the intervention (at baseline) and 8 weeks of intervention | 
| Changes in Employment before the start of the intervention (at baseline) and 3 months from the end of the intervention. | Employment Barriers Questionnaire. It consists of 77 numerical items to assess workers barriers at the time of the questionnaire. The items are scored on a 0-4 Likert scale and measure the two dimensions of environmental and occupational barriers. | Data will be collected before the start of the intervention (at baseline) and 3 months from the end of the intervention | 
| Changes in Employment before the start of the intervention (at baseline) and 12 months from the end of the intervention. | Employment Barriers Questionnaire. It consists of 77 numerical items to assess workers barriers at the time of the questionnaire. The items are scored on a 0-4 Likert scale and measure the two dimensions of environmental and occupational barriers. | Data will be collected before the start of the intervention (at baseline) and 12 months from the end of the intervention | 
| Changes in Employment before the start of the intervention (at baseline) and 24 months from the end of the intervention. | Employment Barriers Questionnaire. It consists of 77 numerical items to assess workers barriers at the time of the questionnaire. The items are scored on a 0-4 Likert scale and measure the two dimensions of environmental and occupational barriers. | Data will be collected before the start of the intervention (at baseline) and 24 months from the end of the intervention | 
| Changes in Neuropathy before the start of the intervention (at baseline) and 8 weeks of intervention | Neuropathy Questionnaire (EORTCOLO QLQ-CIPN20). This is a 20-item patient self-report CIPN-specific questionnaire that includes three subscales assessing sensory, motor, and autonomic symptoms with each item measured on a 1-4 Likert scale (1 being not at all and 4 being very much). Items in the sensory subscale inquire about tingling, numbness, and shooting/burning pain separately for (1) fingers and hands as well as (2) toes and feet. | Data will be collected before the start of the intervention (at baseline) and 8 weeks of intervention | 
| Changes in Neuropathy before the start of the intervention (at baseline) and 3 months from the end of the intervention. | Neuropathy Questionnaire (EORTCOLO QLQ-CIPN20). This is a 20-item patient self-report CIPN-specific questionnaire that includes three subscales assessing sensory, motor, and autonomic symptoms with each item measured on a 1-4 Likert scale (1 being not at all and 4 being very much). Items in the sensory subscale inquire about tingling, numbness, and shooting/burning pain separately for (1) fingers and hands as well as (2) toes and feet. | Data will be collected before the start of the intervention (at baseline) and 3 months from the end of the intervention | 
| Changes in Neuropathy before the start of the intervention (at baseline) and 12 months from the end of the intervention. | Neuropathy Questionnaire (EORTCOLO QLQ-CIPN20). This is a 20-item patient self-report CIPN-specific questionnaire that includes three subscales assessing sensory, motor, and autonomic symptoms with each item measured on a 1-4 Likert scale (1 being not at all and 4 being very much). Items in the sensory subscale inquire about tingling, numbness, and shooting/burning pain separately for (1) fingers and hands as well as (2) toes and feet. | Data will be collected before the start of the intervention (at baseline) and 12 months from the end of the intervention | 
| Changes in Neuropathy before the start of the intervention (at baseline) and 24 months from the end of the intervention. | Neuropathy Questionnaire (EORTCOLO QLQ-CIPN20). This is a 20-item patient self-report CIPN-specific questionnaire that includes three subscales assessing sensory, motor, and autonomic symptoms with each item measured on a 1-4 Likert scale (1 being not at all and 4 being very much). Items in the sensory subscale inquire about tingling, numbness, and shooting/burning pain separately for (1) fingers and hands as well as (2) toes and feet. | Data will be collected before the start of the intervention (at baseline) and 24 months from the end of the intervention | 
| Changes in duration of working hours before the start of the intervention (at baseline) and 8 weeks of intervention | Duration of working hours - self-report by the study participants | Data will be collected before the start of the intervention (at baseline) and 8 weeks of intervention | 
| Changes in duration of working hours before the start of the intervention (at baseline) and 3 months from the end of the intervention. | Duration of working hours - self-report by the study participants | Chang in Employment before the start of the intervention (at baseline) and 3 months from the end of the intervention. | 
| Changes in duration of working hours before the start of the intervention (at baseline) and 12 months from the end of the intervention. | Duration of working hours - self-report by the study participants | Chang in Employment before the start of the intervention (at baseline) and 12 months from the end of the intervention. | 
| Changes in duration of working hours before the start of the intervention (at baseline) and 24 months from the end of the intervention. | Duration of working hours - self-report by the study participants | Chang in Employment before the start of the intervention (at baseline) and 24 months from the end of the intervention. |