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

Breast Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05427344
• Other study ID #: Michal Nissim 2
• Status: Recruiting
• Phase: N/A
• Start date: April 1, 2023
• Est. completion date: August 30, 2027

Study information

• Verified date: April 2023
• Source: Tel Aviv University
• Contact: Navah Z Ratzon, Prof.
• Phone: +972- 50-5468924
• Email: navah[@]tauex.tau.ac.il
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 150
• Est. completion date: August 30, 2027
• Est. primary completion date: August 30, 2027
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Breast Cancer
• Colon Cancer

Intervention

Other:
• Water exercise group
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.
• Land exercise group
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.
• Control group
Control group who will not perform additional physical activity or receive any extra treatments.

Locations

Country	Name	City	State
Israel	Hadassa Hospital	Jerusalem

Sponsors (3)

Lead Sponsor	Collaborator
Tel Aviv University	Hadassah Medical Organization, Israel National Insurance Institute

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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.
Primary	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.
Primary	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
Primary	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
Primary	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.
Primary	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.
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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.
Primary	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.
Primary	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.