Investigating the Effects of Physical Training with and without Motivational Strategies on Fatigue and Quality of Life in Patients with Cancer
Design
A double-blind clinical trial with two parallel groups of control and intervention on 20 cancer patients -the sealed envelope method is used for randomization.
Settings and conduct
The samples will be selected from Rehabilitation Faculty Clinic of Iran University of Medical Sciences and Rasoul Akram Hospital in Tehran, Shahid Motahari Clinic and Raz medical complex in shiraz. They will randomly assigned to the intervention or control group after completing the informed consent form. The participants and the assessor is blinded. The evaluation will be done in 3 time points: the beginning, after 6 weeks and follow-up 6 weeks later.
Participants/Inclusion and exclusion criteria
People with cancer over 18 years of age with fatigue; able to walk independently; Having the ability to understand research objectives and fill out questionnaires in Persian language; obtaining permission from an oncologist; Absence of pathologies that prevent exercises; absence of uncontrolled lymphedema, fever, uncontrolled active infection, diabetes, or brain or bone metastases; not having cognitive impairment according to the MMSE; not having severe anxiety or depression according to the HADS scale.
Intervention groups
Both intervention and control groups, according to the intensity of fatigue reported by the patient on the VAS scale, resistance exercises (for upper limbs, lower limbs and trunk) with moderate intensity and aerobic exercises with moderate intensity (at 60-80% of maximum heart rate) will receive for 6 weeks. In the intervention group, motivational strategies will be also used to increase the participants' motivation.
Main outcome variables
Cancer related fatigue and Quality of Life
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20240223061087N1
Registration date:2024-04-19, 1403/01/31
Registration timing:registered_while_recruiting
Last update:2024-04-19, 1403/01/31
Update count:0
Registration date
2024-04-19, 1403/01/31
Registrant information
Name
Setare Nasrollahi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 2225 6434
Email address
snasrollahi.7677@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-04-03, 1403/01/15
Expected recruitment end date
2024-09-20, 1403/06/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Investigating the Effects of Physical Training with and without Motivational Strategies on Fatigue and Quality of Life in Patients with Cancer
Public title
Effects of Physical Training with and without Motivational Strategies in Patients with Cancer
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients diagnosed with cancer over 18 years of age who report fatigue in their daily life activities
Patients must have the oncologist's permission to start exercising
Participants should not have conditions that prevent them from doing exercises; including cardiovascular diseases (uncontrolled high blood pressure, arrhythmia and aortic aneurysm), respiratory diseases (chronic obstructive pulmonary disease, pulmonary hypertension, severe dyspnea)
Participants should not have uncontrolled lymphedema, fever, or uncontrolled active infection (based on clinical observations and medical record review)
Participants should not have cognitive dysfunction (score below 24 on the MMSE test)
Participants should not have major anxiety disorders or major depression; (HADS-D ≤11) and (HADS-A ≤11)
Participants should not have diabetes, brain or bone metastases.
Participants must be able to walk independently
Participants must have the ability to understand the research objectives and fill in the questionnaires in Persian language
Participants should not be evaluated or receive exercises for 24 hours after chemotherapy.
Exclusion criteria:
Lack of attendance and participation to complete treatment sessions (more than 2 sessions)
Simultaneous use of other rehabilitation services (occupational therapy or physiotherapy) or professional sports
Recurrence of cancer during the time of intervention and changes in patients' drugs and treatment regimen
Age
From 18 years old
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Outcome assessor
Sample size
Target sample size:
20
Randomization (investigator's opinion)
Randomized
Randomization description
In this study, the sealed envelope method is used for randomization. Participants were randomly assigned sealed envelopes labeled "physical exercise" and "physical exercise with motivational strategies"; are grouped. This process is done by someone who has no participation in the analysis or intervention.
Blinding (investigator's opinion)
Double blinded
Blinding description
The evaluation of the results of this study is done by skilled people who are unaware of the assignment of people to groups. Also because all the participants receive basic physical exercises; They will be unaware of the group they are in.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Research Ethics Committees of Iran University of Medical Sciences
Street address
School of Rehabilitation Sciences of Iran University of Medical Sciences, Madadkaran Ave., Shahnazari Ave., Madar Square, Mirdamad, Tehran.
City
Tehran
Province
Tehran
Postal code
1545913487
Approval date
2024-02-04, 1402/11/15
Ethics committee reference number
IR.IUMS.REC.1402.979
Health conditions studied
1
Description of health condition studied
Cancer(neoplasm)
ICD-10 code
C00-D48
ICD-10 code description
Neoplasm
Primary outcomes
1
Description
Cancer Related Fatigue
Timepoint
Before the intervention, after the intervention and 6 weeks after the end of the intervention
Method of measurement
Functional Assessment of Chronic Illness Therapy-Fatigue Scale (FACIT-Fatigue) Questionnaire and Multi Dimensional Fatigue(MFI) Questionnaire
Secondary outcomes
1
Description
Quality of life
Timepoint
Before the intervention, after the intervention and 6 weeks after the end of the intervention
Method of measurement
The Short Form Health Survey (SF-12)
2
Description
Engagement in Meaningful Activities
Timepoint
Before the intervention, after the intervention and 6 weeks after the end of the intervention
Method of measurement
Engagement in Meaningful Activities Survey (EMAS)
3
Description
Independence in daily life activities
Timepoint
Before the intervention, after the intervention and 6 weeks after the end of the intervention
Method of measurement
Lawton Instrumental Activities of Daily Living Scale
Intervention groups
1
Description
Intervention group: according to the intensity of fatigue reported by the person on the VAS scale, the degree of fatigue (mild, moderate and severe) is determined. The level of fatigue according to the VAS scale, 1 (the lowest level of fatigue) and 10 (the highest level of fatigue) are considered. Then, based on the person's initial fatigue level and the physical training protocols mentioned in the cancer guidelines, resistance exercises with moderate intensity, for upper limb, lower limb and trunk for 6 weeks (one face-to-face and two virtual sessions of 45-60 minutes each week) will be given to the individual. Virtual meetings are held by the occupational therapist in order to follow up the exercises and solve the problems. According to the conditions of each patient, the most available application will be selected for making video calls in virtual sessions. After each face-to-face session, short videos will be given to the patients to instruct them how to perform the exercises. Each exercise session should include warming up, resistance exercises and cooling down, all of which will be taught by the occupational therapist. Also, patients should do aerobic exercises with moderate intensity (at 60-80% of maximum heart rate) in the form of walking at home twice a week (on the days of the week when resistance exercises are not performed). The time of walking should gradually increase to 30 minutes of walking per day. To perform resistance exercises at home, two weight cuffs (2 kilo grams), and a pulse oximeter will be given to the patients to check the heart rate during the exercises. In order to increase the motivation and adherence of the patients to the exercises in the intervention group, the motivational strategies were approved in the expert panel, consisting of occupational therapists with at least 5 years of clinical experience; will be used.
Category
Rehabilitation
2
Description
Control group: In this study, the control group will receive routine occupational therapy services for cancer patients conducted by an occupational therapist. The patients will receive only physical exercises of moderate intensity and in accordance with the guidelines of physical exercises in cancer patients, without motivational strategies. In the control group, just like the intervention, by making contact with the patients (twice a week), the correctness of the treatment implementation process of the control group will be ensured.
Category
Rehabilitation
Recruitment centers
1
Recruitment center
Name of recruitment center
rehabilitation clinics of Rehabilitation faculty of IUMS
Full name of responsible person
Laleh Lajevardi
Street address
Mirdamad, madadkaran, Rehabilitation faculty of IUMS
City
Tehran
Province
Tehran
Postal code
1545913487
Phone
+98 21 2222 7124
Email
laleh23275@yahoo.com
2
Recruitment center
Name of recruitment center
Shahid Motahari specialist and super-specialist clinic