Clinical trial NCT03521440: Therapeutic Relaxation, Health and Quality of Life
Official title: Effects of Two Therapeutic Relaxation Programs on Health and Quality of Life Indicators of Elderly People Living in the Community
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Independent Living
Keywords: Therapeutic relaxation
Elderly
Community dwelling
Lead sponsor: University of Évora
Sponsor class: OTHER
First posted: 2018-05-11
Enrollment: 64
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Detailed description: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Activities of Daily Living (ADL's)
timeFrame: Change from baseline to 8 weeks, and change from baseline to 12 weeks
measure: Psychomotor Skills
timeFrame: Change from baseline to 8 weeks, and change from baseline to 12 weeks
measure: Cognitive Functioning
timeFrame: Change from baseline to 8 weeks, and change from baseline to 12 weeks
measure: Humour and Emotional States
timeFrame: Change from baseline to 8 weeks, and change from baseline to 12 weeks
measure: Sleep Quality
timeFrame: Change from baseline to 8 weeks, and change from baseline to 12 weeks
measure: Pain Perception
timeFrame: Change from baseline to 8 weeks, and change from baseline to 12 weeks
measure: Pain Perception
timeFrame: Change from baseline to 8 weeks, and change from baseline to 12 weeks
measure: Body Awareness and Dissociation
timeFrame: Change from baseline to 8 weeks, and change from baseline to 12 weeks
measure: Quality of Life
timeFrame: Change from baseline to 8 weeks, and change from baseline to 12 weeks
measure: Body Schema
timeFrame: Change from baseline to 8 weeks, and change from baseline to 12 weeks
measure: Interoceptive Body Awareness
timeFrame: Change from baseline to 8 weeks, and change from baseline to 12 weeks
measure: Corporal Appreciation
timeFrame: Change from baseline to 8 weeks, and change from baseline to 12 weeks
Secondary outcomes:
measure: Sleep Quality
timeFrame: Change from baseline to 8 weeks, and change from baseline to 12 weeks
measure: Biochemical parameters (e.g., cortisol)
timeFrame: Change from baseline to week 4, change from week 4 to week 8, and change from week 8 to week 12
measure: Biochemical parameters (e.g., immunoglobulin A (sIgA)).
timeFrame: Change from baseline to week 4, change from week 4 to week 8, and change from week 8 to week 12
measure: Biochemical parameters (e.g., a-amylase).
timeFrame: Change from baseline to week 4, change from week 4 to week 8, and change from week 8 to week 12
measure: Biochemical parameters (e.g., C-reactive protein).
timeFrame: Change from baseline to week 4, change from week 4 to week 8, and change from week 8 to week 12
Other outcomes:
Locations:
city: Évora
country: Portugal
facility: Escola Superior de Enfermagem S. João de Deus
Study officials:
affiliation: University of Évora
name: Catarina Pereira, PhD
role: STUDY_CHAIR
affiliation: University of Évora
name: Guida Veiga, PhD
role: STUDY_CHAIR
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