Therapeutic Relaxation, Health and Quality of Life

Study Overview
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Brief Summary
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Therapeutic relaxation has shown benefits for improving health and quality of life of community dwelling elderly people. Although little is known about the efficacy of a specific method of therapeutic relaxation - Psychomotor Massage - compared with other relaxation methods. Therefore, the present study aims to examine the effects of two therapeutic programs (Psychomotor Massage and Progressive Muscle Relaxation) on health and quality of life indicators of community dwelling elderly people. This randomized controlled trial will include an intervention period of 8 weeks for control and for the two experimental groups - attending 30-minute sessions, twice a week - and a follow-up period of 4 weeks without intervention. The evaluation will be performed 1) at baseline, 2) at post-intervention and pre-follow-up, and 3) at post-follow-up. The main study variables will be: daily activities, psychomotor abilities, cognitive functioning, emotional states, pain perception, quality of sleep, body awareness and body image, and quality of life. Health biomarkers will be also assessed through saliva analyses.

Detailed Description
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According to World Health Organization, life expectancy of older people continues to rise, and by 2050, the proportion of the world's population above 60 years old will nearly double, from 12% to 22%. However, living longer does not mean living healthier. So, it is urgent to promote effective interventions in elderly people's health, quality of life and independency, aiming to be able to live autonomous in their homes and in community (WHO). Aging involves changes on the body and its functions, for example the praxis skills, which leads to a visible decrease on the performance of Activities of Daily Living (ADL's) (e.g. self-care and domestic activities). These difficulties are also associated to dysfunctionality and poor quality of life. All of these decreases are also associated with emotional problems, sleep disorders, and pain. In recent years, there has been a resurgence of interest in more integrative therapeutic interventions. In particular, therapeutic relaxation programs have been increasingly reported to be effective interventions for preventing the functional and emotional losses, associated to the aging process, as well as for promoting health and quality of life indicators. There is a specific method of therapeutic relaxation - Psychomotor Massage - that has been frequently applied in order to improve health and quality of life indicators of elderly people. However, to the best of the investigator's knowledge, no study has yet examined the effects of such innovative relaxation intervention method, particularly comparing them to the effects of a common therapeutic relaxation method, such as Progressive Muscle Relaxation. Therefore, this experimental randomized controlled trial aims to examine the effects of two therapeutic interventions programs based on the relaxation techniques mentioned above in health and quality of life indicators (daily activities, psychomotor abilities, cognitive functioning, emotional states, pain perception, quality of sleep, body awareness and body image) of community dwelling Portuguese elderly people. Subjects above 60 years living in the community will be invited to participate in this study and will be randomized by three groups: control, Psychomotor Massage, and Progressive Muscle Relaxation. Along the study, all patients will continue to receive the usual care from their medical providers. The study will include an intervention period of 8 weeks for control and for the two experimental groups - attending 30-minute sessions, twice a week - and a follow-up period of 4 weeks without intervention. Evaluation will be performed 1) at baseline, 2) at post-intervention and pre-follow-up, and 3) at post-follow-up. The study was approved by the Ethics Committee of the University of Évora, Portugal, and will be carried out in accordance with the standards set by the Declaration of Helsinki. The collected data will be fully encrypted to ensure the privacy of the participants.

Official Title
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Effects of Two Therapeutic Relaxation Programs on Health and Quality of Life Indicators of Elderly People Living in the Community

Conditions
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Independent Living

Intervention / Treatment
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* Behavioral: Psychomotor Massage
* Behavioral: Progressive Muscle Relaxation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: ≥ 60 years Community dwelling Absence of cognitive impairment: cut-off < 22 at Mini Mental State Examination Able to participate at assessments Able to participate at therapeutic sessions

Ages Eligible for Study
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Minimum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Psychomotor Massage<br>Participants will be randomly allocated to individual sessions, and will receive two 30-minute individual sessions per week, for 8 weeks. | Behavioral: Psychomotor Massage<br>* Sessions will be conducted by a graduated therapist, experienced in Psychomotor Massage and weekly supervised by a specialist in this therapeutic approach. The Psychomotor Massage involves smoothly touching the head, upper and lower limbs, followed by micro-stretching and slow mobilisations of upper and lower limbs.<br>|
| Experimental: Progressive Muscle Relaxation<br>Participants will participate in 30-minute group sessions, twice a week, for 8 weeks. | Behavioral: Progressive Muscle Relaxation<br>* Sessions will be conducted by a graduated therapist, experienced in Progressive Muscle Relaxation, and weekly supervised by a specialist in this therapeutic approach. The Progressive Muscle Relaxation protocol consists in tensing and releasing 16 muscle groups for several seconds, following a specific order.<br>* Other names: Progressive Muscle Training;|
| No Intervention: Waiting List<br>Participants will maintain their daily routines through the experimental intervention period. After finishing all periods of data collection, participants will be invited to participate in one of the interventions previously offered to the experimental groups. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Activities of Daily Living (ADL's) | The Portuguese version of Katz Index of ADL's grades (Duarte, Y. A. O., Andrade, C. L., & Lebrão, M. L., 2007) summarizes overall performance in six functions: bathing, dressing, going to toilet, transferring, continence and feeding. Time for application is 5 minutes. For each ADL the subject is classified as Dependent (0) or Independent (1). If the subject refuses, or is not used to a certain task, he is classified as Dependent in the respective activity. The final punctuation results from the sum of the 6 function scoring, and corresponds to the number of activities in which the subject is independent. The scale demonstrated adequate psychometric properties with strong reliability. | Change from baseline to 8 weeks, and change from baseline to 12 weeks | 
| Psychomotor Skills | The Portuguese version of Éxamen Géronto-Psychomoteur (P-EGP; Morais, Santos, & Lebre, 2017) is a measuring instrument of psychomotor skills of people above 60 years and aims to establish an individual psychomotor profile. The instrument consists of 17 items which assess: static and dynamic balance, joint mobilizations, praxis, fine motor skills of upper and lower limbs, knowledge of body parts, vigilance, perception, verbal and perceptive memory, spatial and temporal domain, and verbal and nonverbal communication. Each item is scored on a six-point scale, some with a set of sub-items inside. Time application is about 60 minutes. The P-EGP has been shown to have adequate psychometric properties. | Change from baseline to 8 weeks, and change from baseline to 12 weeks | 
| Cognitive Functioning | Wisconsin Card Sorting Test (WCST; Heaton, Chelune, Talley, Kay, & Curtiss, 1993) is constituted by carts that vary in term of their contents (forms, colours, figures). Subject is asked to correspond each answer-card to one of the four stimulus-card (on red triangle, two green stars, three yellow crosses, and four blue circles). WSCT implies the subject to develop a response pattern and implement an action plan, and provide ways to understand the cognitive flexibility, respond stiffness and problem-solving capacity. WSCT also involves the strategic planning, the organized visual processing, the processing speed, the skill to use environment feedback and select the relevant characteristics of stimuli, the work memory, impulsive response modulation, and the adoption of behaviours oriented to goals. The version that will be used has two blocks of 64 cards. Time application is about 15/30 minutes. The WCST shows good psychometric properties. | Change from baseline to 8 weeks, and change from baseline to 12 weeks | 
| Humour and Emotional States | The Portuguese version of short form Profile of Mood States (P-POMS; Viana, Almeida, & Santos, 2001) have 22 items, which allows to assess humour and emotional states. Respondents indicate in a 5-point likert scale (0=not at all to 4=extremely) to what extent each adjective describes them during the last week. Standard scoring of the POMS yields a global distress score and six subscales: Fatigue-Inertia, Vigour-Activity, Tension-Anxiety, Depression-Melancholy, Anger-Hostility, and Confusion-Disorientation. Completion of the POMS takes approximately 3 to 7 minutes (Viana et al., 2001). The Portuguese version of the POMS shows good psychometric properties (Viana et al., 2001). | Change from baseline to 8 weeks, and change from baseline to 12 weeks | 
| Sleep Quality | The Portuguese version of Pittsburgh Sleep Quality Index (P-PSQI; Del Rio João, Becker, Jesus, & Martins, 2017) is a 19-item questionnaire that measures sleep quality over the last month. The questionnaire comprises 19 items rated in a 3-point scale, that measures (1) subjective sleep quality, (2) sleep latency, (3) sleep duration, (4) habitual sleep efficiency, (5) sleep disturbances, (6) use of sleeping medication, and (7) daytime dysfunction. Higher scores indicate worst sleep quality. This questionnaire is easily understood and takes 5 to 10 minutes to be answered. The PSQI-PT has adequate psychometric properties. | Change from baseline to 8 weeks, and change from baseline to 12 weeks | 
| Pain Perception | The Portuguese version of Brief Pain Inventory - Short Form (P-BPI; Ferreira-Valente, Pais-Ribeiro, & Jensen, 2012) comprises 15 items which assess pain interference across seven ADL's (i.e. general activity, mood, walking ability, normal work, relations with other people, sleep, and enjoyment of life) on 0 to 10 numerical scales. This version of the BPI retained the front and back body diagrams, the four pain severity items and seven pain interference items rated on 0-10 scales, and the question about percentage of pain relief by analgesics. This is a valid instrument, reproducible and sensible in detection, monitoring and characterization of pain, with excellent psychometric properties (Cronbach's alpha above .80). | Change from baseline to 8 weeks, and change from baseline to 12 weeks | 
| Pain Perception | The Visual Analogue Scale (VAS; Huskisson,1983) is a unidimensional self-rated instrument that allow quantify the subjective pain intensity. VAS is presented as a horizontal straight line of 10 centimetres, numbered from 0 (zero) to 10 (ten), which 0=without pain, 1 to 3=mild/light pain, 4 to 6=moderate pain, and 7 to 10=severe pain. This one is the worst pain possible. Participants are instructed to indicate a point on the line, correspondent to the intensity pain that they felt in the last week, including today. Standard is obtained through the measure between the point 0 (without pain) and the point marked by the participant. The score rate is from 0 to 10. VAS demonstrates good reliability scores through test-retest application with greater results with literate (r=.94, p<.001) compared with illiterate (r=.71, p=<.001). | Change from baseline to 8 weeks, and change from baseline to 12 weeks | 
| Body Awareness and Dissociation | The Portuguese version of Scale of Body Connection (P-SBC) is constituted by 2 subscales designed to assess body awareness and bodily dissociation in mind body intervention research, and 20 items self-report using a 5-point Likert scale format, in which 0=not at all; 1=a little bit; 2=some of the time; 3=most of the time; and, 4=all of the time. For scoring the Body Awareness (BA) subscale: sum score of items (items 1, 3, 4, 6, 8, 9, 12, 13, 14, 15, 17, 18) and divide by total number of items (12). For scoring the Body Dissociation (BD) subscale: sum score of items (items 2, 5, 7, 10, 11, 16, 19, 20) and divide by total number of items (8). For scoring Total Scale: revert the punctuation of the body dissociation subscale, sum the score of all items, and divide by total number of items (20). The P-SBC showed adequate psychometric properties (Cronbach's alpha coefficients of .86 for BA and .73 for BD). | Change from baseline to 8 weeks, and change from baseline to 12 weeks | 
| Quality of Life | The Portuguese version of Medical Outcomes Short-Form Health Survey (P-SF-36; Ferreira, 2000) is a non-specific questionnaire for health- related quality of life. The SF-36 consists of eight subscales as follows: physical functioning, role physical, bodily pain, general health, vitality, social functioning, role emotional and mental health. The P-SF-36 has been validated with adequate psychometric qualities. | Change from baseline to 8 weeks, and change from baseline to 12 weeks | 
| Body Schema | The evaluation of the body schema will be done through the Image Marking Procedure (Askevold, 1975). This procedure consists in a self-recording of certain body points (body height, acromio-clavicular joints, narrowest waist width and the trochanters of the femoral bones) on one piece of paper (1x1.5m) taped to the wall. The subjects are asked to stand in front of the paper and to imagine that they are looking at themselves through a mirror, while the investigator stands behind them and with his finger he touches the body points chosen for marking. The subjects are then asked to mark where they see these points in the mirror. When the marking is finished, the investigator marks the correct position of the body points to compare these ones with the subjects' perceptive marks. This procedure shows good reliability, with values between 0.72 and 0.92. | Change from baseline to 8 weeks, and change from baseline to 12 weeks | 
| Interoceptive Body Awareness | The Portuguese translation of Multidimensional Assessment of Interoceptive Awareness (MAIA; Machorrinho, Veiga & Marmeleira (2017), will be used to measure interoceptive body awareness. This questionnaire has 32 items, which are organized in 8 different subscales (Noticing, Not-distracting, Not-worrying, Attention Regulation, Emotional Awareness, Self-Regulation, Body Listening and Trusting) and tested on a Likert scale, with six levels of ordinal response coded from 0 (never) to 5 (always). It was verified that the Portuguese version has good temporal reliability with correlation values of all scales between 0.52 and 0.83. | Change from baseline to 8 weeks, and change from baseline to 12 weeks | 
| Corporal Appreciation | The Body Assessment Scale (Avalos, Tylka e Wood-Barcalow, 2005) will be used in its translated and adapted version to the Portuguese language by Félix Neto (2011, quoted by Baldaia, 2013) to quantify the corporal appreciation. The Portuguese version consists of 14 items about the positive qualities of the body image and the answers are obtained on a Likert scale composed of 5 points from 1 (never) and 5 (always). Its reliability was verified by the application of Cronbach's alpha and the obtained value was α = 0.86 (Baldaia, 2013), which is similar with the results of both studies by Avalos, Tylka and Wood-Barcalow (2005) where the alpha values were equal to 0.91 and 0.93. Within this same subject, there will also be an open question about Body Image. | Change from baseline to 8 weeks, and change from baseline to 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Sleep Quality | Patient will use the accelerometer ActiGraph wGT3X-BT during 4 days and 3 nights. Sleep Latency, Total Sleep Time, Wake After Sleep Onset and Sleep Efficiency will be assessed. The captures and records high resolution raw acceleration data, which is converted into a variety of objective activity and sleep measures using publicly available algorithms developed and validated by members of the academic research community. Available measures include: Body Position, Sleep Latency, Total Sleep Time, Wake After Sleep Onset, and Sleep Efficiency (ActiGraph, 2018). | Change from baseline to 8 weeks, and change from baseline to 12 weeks | 
| Biochemical parameters (e.g., cortisol) | Data (a saliva sample in a Salivette (r) tube) will be collect at: baseline, 10/15 minutes after baseline and immediately before the intervention and immediately after the intervention, at 1st, 8th, 16th sessions of therapeutic intervention. In follow-up assessment, data will be collect at baseline and 10/15 minutes after baseline, at 4th week. Samples will be collect at the same hour and period of the day in all moments of collection. After collected, were refrigerated. Therefore, participants of experimental groups will have 11 measurements, and participants of control group will have 8 measurements. Cortisol was measured in the standard unit of nmol/l. | Change from baseline to week 4, change from week 4 to week 8, and change from week 8 to week 12 | 
| Biochemical parameters (e.g., immunoglobulin A (sIgA)). | Data (a saliva sample in a Salivette (r) tube) will be collect at: baseline, 10/15 minutes after baseline and immediately before the intervention and immediately after the intervention, at 1st, 8th, 16th sessions of therapeutic intervention. In follow-up assessment, data will be collect at baseline and 10/15 minutes after baseline, at 4th week. Samples will be collect at the same hour and period of the day in all moments of collection. After collected, were refrigerated. Therefore, participants of experimental groups will have 11 measurements, and participants of control group will have 8 measurements. sIgA concentration in the standard unit of µg/ml. | Change from baseline to week 4, change from week 4 to week 8, and change from week 8 to week 12 | 
| Biochemical parameters (e.g., a-amylase). | Data (a saliva sample in a Salivette (r) tube) will be collect at: baseline, 10/15 minutes after baseline and immediately before the intervention and immediately after the intervention, at 1st, 8th, 16th sessions of therapeutic intervention. In follow-up assessment, data will be collect at baseline and 10/15 minutes after baseline, at 4th week. Samples will be collect at the same hour and period of the day in all moments of collection. After collected, were refrigerated. Therefore, participants of experimental groups will have 11 measurements, and participants of control group will have 8 measurements. Since most assay techniques employed to date make use of sAA's enzymatic activity, the most frequently used unit of measurement is enzyme units per milliliter (U/ml). | Change from baseline to week 4, change from week 4 to week 8, and change from week 8 to week 12 | 
| Biochemical parameters (e.g., C-reactive protein). | Data (a saliva sample in a Salivette (r) tube) will be collect at: baseline, 10/15 minutes after baseline and immediately before the intervention and immediately after the intervention, at 1st, 8th, 16th sessions of therapeutic intervention. In follow-up assessment, data will be collect at baseline and 10/15 minutes after baseline, at 4th week. Samples will be collect at the same hour and period of the day in all moments of collection. After collected, were refrigerated. Therefore, participants of experimental groups will have 11 measurements, and participants of control group will have 8 measurements. C-reactive protein in the standard unit of mg/mL. | Change from baseline to week 4, change from week 4 to week 8, and change from week 8 to week 12 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Therapeutic relaxation, Elderly, Community dwelling