Therapeutic Relaxation, Health and Quality of Life

NCT03521440 | Unknown

• 1 other identifier: Universidade de Evora
• Study Type: interventional
• Target: 64
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Independent Living

Keywords

Therapeutic relaxation; Elderly; Community dwelling

Outcome Measures

Primary Outcomes (12)

• 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 Outcomes (5)

• Sleep Quality

  Change from baseline to 8 weeks, and change from baseline to 12 weeks

• Biochemical parameters (e.g., cortisol)

  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)).

  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).

  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).

  Change from baseline to week 4, change from week 4 to week 8, and change from week 8 to week 12

Study Arms (3)

Psychomotor Massage

EXPERIMENTAL

Participants will be randomly allocated to individual sessions, and will receive two 30-minute individual sessions per week, for 8 weeks.

Behavioral: Psychomotor Massage

Progressive Muscle Relaxation

EXPERIMENTAL

Participants will participate in 30-minute group sessions, twice a week, for 8 weeks.

Behavioral: Progressive Muscle Relaxation

Waiting List

NO INTERVENTION

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.

Interventions

Psychomotor Massage BEHAVIORAL

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.

Psychomotor Massage

Progressive Muscle Relaxation BEHAVIORAL

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.

Also known as: Progressive Muscle Training

Progressive Muscle Relaxation

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• ≥ 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

Sponsors & Collaborators

• University of Évora: lead

Study Sites (1)

Escola Superior de Enfermagem S. João de Deus

Evora, 7000, Portugal

Location

Related Publications (24)

• ActiGraph, L. (2018). ActiGraph wGT3X-BT. Retrieved April 10, 2018, from https://www.actigraphcorp.com/actigraph-wgt3x-bt/

  BACKGROUND

• Askevold F. Measuring body image. Preliminary report on a new method. Psychother Psychosom. 1975;26(2):71-7. doi: 10.1159/000286913.

  PMID: 1202548 BACKGROUND

• Avalos L, Tylka TL, Wood-Barcalow N. The Body Appreciation Scale: development and psychometric evaluation. Body Image. 2005 Sep;2(3):285-97. doi: 10.1016/j.bodyim.2005.06.002. Epub 2005 Aug 26.

  PMID: 18089195 BACKGROUND

• Bair MJ, Wu J, Damush TM, Sutherland JM, Kroenke K. Association of depression and anxiety alone and in combination with chronic musculoskeletal pain in primary care patients. Psychosom Med. 2008 Oct;70(8):890-7. doi: 10.1097/PSY.0b013e318185c510. Epub 2008 Sep 16.

  PMID: 18799425 BACKGROUND

• Baldaia, A. (2013). A atratividade física e o seu contributo para o envelhecimento bem-sucedido. Actas de Gerontologia, 1(1), 1-8.

  BACKGROUND

• Cunha, L., & Mayrink, W. (2011). Influência da dor crônica na qualidade de vida em idosos. Revista Da Dor, 12(2), 120-124

  BACKGROUND

• Del Rio Joao KA, Becker NB, de Neves Jesus S, Isabel Santos Martins R. Validation of the Portuguese version of the Pittsburgh Sleep Quality Index (PSQI-PT). Psychiatry Res. 2017 Jan;247:225-229. doi: 10.1016/j.psychres.2016.11.042. Epub 2016 Nov 28.

  PMID: 27923147 BACKGROUND

• Ferreira-Valente, M. A., Pais-Ribeiro, J. L., & Jensen, M. P. (2012). Further Validation of a Portuguese Version of the Brief Pain Inventory Interference Scale. Clínica Y Salud, 23(1), 89-96. http://doi.org/10.5093/cl2012a6

  BACKGROUND

• Ferreira PL. [Development of the Portuguese version of MOS SF-36. Part II --Validation tests]. Acta Med Port. 2000 May-Jun;13(3):119-27. Portuguese.

  PMID: 11026151 BACKGROUND

• Gebretsadik M, Jayaprabhu S, Grossberg GT. Mood disorders in the elderly. Med Clin North Am. 2006 Sep;90(5):789-805. doi: 10.1016/j.mcna.2006.05.015.

  PMID: 16962842 BACKGROUND

• Heaton, R., Chelune, G., Talley, J., Kay, G., & Curtiss, G. (1993). Wisconsin Card Sorting Test Manual: Revised and expanded. (Psychological Assessment Resources Inc, Ed.). Odessa.

  BACKGROUND

• Huskisson, E. C. (1983). Visual Analogue Scales. In Raven Press (Ed.), Pain Measurement and Assessment (pp. 33-37). New York

  BACKGROUND

• Lino VT, Pereira SR, Camacho LA, Ribeiro Filho ST, Buksman S. [Cross-cultural adaptation of the Independence in Activities of Daily Living Index (Katz Index)]. Cad Saude Publica. 2008 Jan;24(1):103-12. doi: 10.1590/s0102-311x2008000100010. Portuguese.

  PMID: 18209838 BACKGROUND

• Machorrinho, J., Veiga, G., & Marmeleira, J. (2017). Propriedades psicométricas da versão portuguesa do Multidimentional Assessment of Interoceptive Awareness (MAIA). Universidade de Évora.

  BACKGROUND

• Morais, A., Santos, S., & Lebre, P. (2016). Psychometric Properties of the Portuguese Version of the Éxamen Geronto-Psychomoteur (P- EGP). Educational Gerontology. http://doi.org/10.1080/03601277.2016.1165068

  BACKGROUND

• Morais A, Santos S, Lebre P. Psychomotor, Functional, and Cognitive Profiles in Older People with and without Dementia:What Connections? Dementia (London). 2019 May;18(4):1538-1553. doi: 10.1177/1471301217719624. Epub 2017 Jul 28.

  PMID: 28752771 BACKGROUND

• Neves, C. F., Price, C. J., & Carvalheira, A. (2017). The psychometric properties of the Scale of Body Connection (SBC) in a Portuguese sample. Psychology, Community & Health, 6(1), 158-169. http://doi.org/10.5964/pch.v6i1.223

  BACKGROUND

• Orsal O, Alparslan GB, Ozkaraman A, Sonmez N. The effect of relaxation exercises on quality of sleep among the elderly: holistic nursing practice review copy. Holist Nurs Pract. 2014 Jul-Aug;28(4):265-74. doi: 10.1097/HNP.0000000000000032.

  PMID: 24919097 BACKGROUND

• Rubenstein LZ. Falls in older people: epidemiology, risk factors and strategies for prevention. Age Ageing. 2006 Sep;35 Suppl 2:ii37-ii41. doi: 10.1093/ageing/afl084.

  PMID: 16926202 BACKGROUND

• Santana I, Duro D, Lemos R, Costa V, Pereira M, Simoes MR, Freitas S. [Mini-Mental State Examination: Screening and Diagnosis of Cognitive Decline, Using New Normative Data]. Acta Med Port. 2016 Apr;29(4):240-8. doi: 10.20344/amp.6889. Epub 2016 Apr 29. Portuguese.

  PMID: 27349775 BACKGROUND

• Seidler RD, Bernard JA, Burutolu TB, Fling BW, Gordon MT, Gwin JT, Kwak Y, Lipps DB. Motor control and aging: links to age-related brain structural, functional, and biochemical effects. Neurosci Biobehav Rev. 2010 Apr;34(5):721-33. doi: 10.1016/j.neubiorev.2009.10.005. Epub 2009 Oct 20.

  PMID: 19850077 BACKGROUND

• Tel, H. (2013). Sleep quality and quality of life among the elderly people. Neurology Psychiatry and Brain Research, 19(1), 48-52. http://doi.org/10.1016/j.npbr.2012.10.002

  BACKGROUND

• Viana, M. F., Almeida, P. L. de, & Santos, R. C. (2001). Adaptação portuguesa da versão reduzida do Perfil de Estados de Humor - POMS. Análise Psicológica, 1(19), 77-92. Retrieved from http://publicacoes.ispa.pt/index.php/ap/article/view/345

  BACKGROUND

• World Health Organization. (2017). Mental health of older adults. Retrieved from http://www.who.int/mediacentre/factsheets/fs381/en/

  BACKGROUND

MeSH Terms

Interventions

Autogenic Training

Intervention Hierarchy (Ancestors)

Hypnosis; Mind-Body Therapies; Complementary Therapies; Therapeutics; Psychotherapy; Behavioral Disciplines and Activities

Study Officials

• Catarina Pereira, PhD

  University of Évora

  STUDY CHAIR

• Guida Veiga, PhD

  University of Évora

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: April 20, 2018
• First Posted: May 11, 2018
• Study Start: April 16, 2018
• Primary Completion: April 27, 2018
• Study Completion: August 1, 2018
• Last Updated: May 23, 2018

Record last verified: 2018-05

Locations

PT (1)