Overview
As people live longer, long-term pain becomes more common in old age. This type of pain can greatly affect quality of life, reduce independence in daily activities, and diminish overall well-being.
This study is part of a project called PReGe, which aims to help older adults age actively and healthily through preventive physiotherapy. The goal is to determine whether a combination of adapted exercise and education about how pain works can help improve the lives of those who suffer from it.
The study is supported by the City Council of Salamanca and the Faculty of Nursing and Physiotherapy, and it is carried out in collaboration with the Doctoral Program in Health, Disability, Dependency, and Well-being at the University of Salamanca.
The purpose of this study is to determine whether a program that combines physical exercise with educational sessions about pain is more effective for adults over 65 years of age with chronic pain, compared to doing exercise alone. The study aims to find out whether this program improves pain, understanding of pain, mobility, quality of life and Quantitative Electroencephalography (qEEG).
This is a medical research study involving participants aged 65 years or older who have experienced pain for more than three months, with an intensity of at least 3 on a 0-to-10 scale. Participants will be randomly assigned to one of three groups, each following a different type of program:
Group 1 (Control Group): will perform only adapted physical exercise. Group 2: will perform the same physical exercise and attend educational sessions about pain for 8 weeks.
Group 3: will also perform the physical exercise and attend the educational sessions, but for a period of 32 weeks.
The study will last for one full year. The exercise program will be supervised by physiotherapists, carried out over 32 weeks, three times per week, with each session lasting approximately 50 minutes. The educational sessions on pain will be brief-about 15 minutes each-and will take place immediately before the exercise sessions.
During the first two months, there will be two educational talks per week. After the Christmas break, Group 3 will continue with one talk every two weeks until the end of the study.
Three evaluations will be conducted: one before starting the program, another at two months (questionnaires and qEEG only), and a final one at nine months. The initial and final evaluation sessions will last approximately 75 minutes per participant, while the intermediate evaluation of the questionnaires will take about 45 minutes per person.
The evaluators who conduct the assessments will not know which group each participant belongs to, to ensure that the results are as objective as possible.
Description
During the course of the study, the following information will be collected, and the following types of tests and assessments will be carried out:
Personal information and medical history.
Physical condition assessments:
- Functional assessment: the following tests will be conducted: Short Physical Performance Battery (SPPB) and Timed Up \& Go (TUG).
- Muscle strength assessment: the following tests will be performed: handgrip strength test using a JAMAR dynamometer, five-times sit-to-stand test, and force-velocity profiling using an ADR Encoder.
- Body composition assessment: will be obtained by bioelectrical impedance analysis (BIA), including measurements of body weight, body mass index (BMI), body fat, visceral fat, appendicular muscle mass, and appendicular mass index.
- Questionnaires
- Numerical Rating Scale for Pain (NRS)
- Tampa Scale for Kinesiophobia (TSK-11SV)
- Pain Catastrophizing Scale
- Spanish version of the Graded Chronic Pain Scale
- SF-12 Health Survey
Quantitative Electroencephalography (qEEG): (Spectral domain (brain frequencies, absolute and relative power by band), functional connectivity indices (coherence between regions), topographical or localization indices, complexity or temporal dynamics indices).
All assessments will be administered by a trained and blinded physiotherapist under optimal hygiene and safety conditions, using certified equipment and instruments.
Eligibility
Inclusion Criteria:
- Adults over 65 years of age
- History of pain lasting more than 3 months.
- Pain intensity of at least 3 out of 10 on the numeric pain rating scale.
- Ability to understand, speak, and write in Spanish.
Exclusion Criteria:
- Severe cognitive impairment (score \< 24 on the Mini-Mental State Exam).
- Psychiatric disorders.
- Uncontrolled systemic or inflammatory conditions.
- Uncontrolled cardiac conditions.
- Any other circumstances deemed by the investigators that could interfere with the study's purpose or conduct.
Elimination Criteria:
\- Attendance below 85% of total sessions.