Colon CancerNCT05427344
Effectiveness of Aquatic Exercise on Fatigue, Neuropathy and Quality of Life Among Cancer Patients
A study testing Water exercise group and Land exercise group in people with Colon Cancer and Breast Cancer, run by Tel Aviv University at 1 site in Israel.
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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Colon Cancer, Breast Cancer
- What is being tested?
- Water exercise group and Land exercise group
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteIsrael
- Study dates
- 1 Apr 2023to 23 Nov 2024
- 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 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read more
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).
- Conditions
- Colon Cancer, Breast Cancer
- Being tested
- Water exercise group, Land exercise group, Control group
- Medical subject headings
- Colonic Neoplasms, Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Water exercise groupOther
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 groupOther
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 groupOther
Control group who will not perform additional physical activity or receive any extra treatments.
| Study group | Role | What they receive |
|---|---|---|
| Water exercise group | Experimental | 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 Receives: Other: Water exercise group |
| Land exercise group | Experimental | 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 Receives: Other: Land exercise group |
| Control group | Experimental | Control group who will not perform additional physical activity or receive any extra treatments Receives: Other: Control group |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 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
Measured: 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
Measured: 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".
Measured: 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".
Measured: 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".
Measured: 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".
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: Chang in Employment before the start of the intervention (at baseline) and 24 months from the end of the intervention.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jun 2022
- Study start1 Apr 2023
- Primary completion23 Nov 2024 (estimated)
- Study completion23 Nov 2024 (estimated)
Why it stopped: The study was stopped because we were unable to recruit participants as planned. Therefore, it was decided to halt the study and participant recruitment.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Colon CancerStudies 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tel Aviv University
- Sponsor type
- University, hospital or other
- Collaborators
- Hadassah Medical Organization
- Responsible party
- Principal investigator, Navah Ratzon, Tel Aviv University
- Investigators
- Navah Z Ratzon, Prof, Principal investigator, Tel Aviv University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05427344
- Sponsor's protocol ID
- Michal Nissim 2
- Status last verified
- Nov 2024
- First submitted
- 7 Oct 2021
- Last updated
- 26 Nov 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Nissim M, Rottenberg Y, Karniel N, Ratzon NZ. Effects of aquatic exercise program versus on-land exercise program on cancer-related fatigue, neuropathy, activity and participation, quality of life, and return to work for cancer patients: study protocol for a randomized controlled trial. BMC Complement Med Ther. 2024 Feb 2;24(1):74. doi: 10.1186/s12906-024-04367-8.
PubMed 38308248
Study at a glance
From the registry record, last updated by the sponsor on 26 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05427344
- Acronym / sponsor ID
- Michal Nissim 2
- Conditions
- Colon Cancer, Breast Cancer
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: The study was stopped because we were unable to recruit participants as planned. Therefore, it was decided to halt the study and participant recruitment.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Tel Aviv UniversityUniversity, hospital or other
- Collaborators
- Hadassah Medical Organization
- Study start
- 1 Apr 2023 (actual)
- Primary completion
- 23 Nov 2024 (estimated)
- Study completion
- 23 Nov 2024 (estimated)
- First posted
- 22 Jun 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.
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).
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Water exercise group | Experimental | Other: Water exercise groupWater 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 | Experimental | Other: Land exercise groupLand 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 | Experimental | Other: Control groupControl group who will not perform additional physical activity or receive any extra treatments |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (2 listed)
- 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
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 |
|---|---|---|
| Water exercise groupWater 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 |
| Land exercise groupLand 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 |
| Control groupControl group who will not perform additional physical activity or receive any extra treatments. | Other | Control group |
Primary outcome
Changes in degree of activity and participation before the start of the intervention (at baseline) and 8 weeks of intervention
Time frame: Data will be collected 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
Changes in degree of activity and participation before the start of the intervention (at baseline) and 3 months from the end of the intervention.
Time frame: Data will be collected 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
Changes in degree of activity and participation, before the start of the intervention (at baseline), and 12 months from the end of the intervention.
Time frame: Data will be collected 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
Changes in degree of activity and participation before the start of the intervention (at baseline) and 24 months from the end of the intervention.
Time frame: Data will be collected 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
Changes in Quality of life before the start of the intervention (at baseline) and 8 weeks of intervention
Time frame: Data will be collected 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".
Changes in Quality of life before the start of the intervention (at baseline) and 3 months from the end of the intervention
Time frame: Data will be collected 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".
Changes in Quality of life before the start of the intervention (at baseline) and 12 months from the end of the intervention
Time frame: Data will be collected 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".
Changes in Quality of life before the start of the intervention (at baseline) and 24 months from the end of the intervention
Time frame: Data will be collected 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".
Changes in Exhaustion and fatigue before the start of the intervention (at baseline) and 8 weeks of intervention
Time frame: Data will be collected 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.
Changes in Exhaustion and fatigue before the start of the intervention (at baseline) and 3 months from the end of the intervention.
Time frame: Data will be collected 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.
Changes in Exhaustion and fatigue before the start of the intervention (at baseline) and 12 months from the end of the intervention.
Time frame: Data will be collected 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.
Changes in Exhaustion and fatigue before the start of the intervention (at baseline) and 24 months from the end of the intervention.
Time frame: Data will be collected 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.
Changes in Employment before the start of the intervention (at baseline) and 8 weeks of intervention
Time frame: Data will be collected 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.
Changes in Employment before the start of the intervention (at baseline) and 3 months from the end of the intervention.
Time frame: Data will be collected 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.
Changes in Employment before the start of the intervention (at baseline) and 12 months from the end of the intervention.
Time frame: Data will be collected 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.
Changes in Employment before the start of the intervention (at baseline) and 24 months from the end of the intervention.
Time frame: Data will be collected 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.
Changes in Neuropathy before the start of the intervention (at baseline) and 8 weeks of intervention
Time frame: Data will be collected 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.
Changes in Neuropathy before the start of the intervention (at baseline) and 3 months from the end of the intervention.
Time frame: Data will be collected 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.
Changes in Neuropathy before the start of the intervention (at baseline) and 12 months from the end of the intervention.
Time frame: Data will be collected 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.
Changes in Neuropathy before the start of the intervention (at baseline) and 24 months from the end of the intervention.
Time frame: Data will be collected 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.
Changes in duration of working hours before the start of the intervention (at baseline) and 8 weeks of intervention
Time frame: Data will be collected before the start of the intervention (at baseline) and 8 weeks of intervention
Duration of working hours - self-report by the study participants
Changes in duration of working hours before the start of the intervention (at baseline) and 3 months from the end of the intervention.
Time frame: Chang in Employment 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
Changes in duration of working hours before the start of the intervention (at baseline) and 12 months from the end of the intervention.
Time frame: Chang in Employment 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
Changes in duration of working hours before the start of the intervention (at baseline) and 24 months from the end of the intervention.
Time frame: Chang in Employment 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
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Nov 2024.
- Derived from this study: PubMed 38308248Nissim M, Rottenberg Y, Karniel N, Ratzon NZ. Effects of aquatic exercise program versus on-land exercise program on cancer-related fatigue, neuropathy, activity and participation, quality of life, and return to work for cancer patients: study protocol for a randomized controlled trial. BMC Complement Med Ther. 2024 Feb 2;24(1):74. doi: 10.1186/s12906-024-04367-8.
- 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.
Navah Z Ratzon, Prof principal investigator
Tel Aviv University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Water exercise group and Land exercise group in people with Colon Cancer and Breast Cancer, run by Tel Aviv University at 1 site in Israel.
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 2 inclusion and 2 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: withdrawn, as of the sponsor's last update on 26 Nov 2024. 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 Israel. 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 was withdrawn before enrolling participants, so there are no results.
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?
Changes in degree of activity and participation before the start of the intervention (at baseline) and 8 weeks of intervention (time frame: Data will be collected before the start of the intervention (at baseline) and 8 weeks of intervention). The study lists 24 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05427344, which also lists 1 linked publication.
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 26 Nov 2024.