Clinical trial NCT06667830: Effectiveness Study of an Exercise Program for Older Adults with Chronic Musculoskeletal Pain
Official title: A Comparative Study of Two Different Physical Exercise Programs to Improve Pain, Functional Status, and Physical Performance in Older Adults with Chronic Musculoskeletal Pain: a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: NA
Conditions: Chronic Musculoskeletal Pain
Keywords: Chronic musculoskeletal pain
Older adults
Exercise program
Physiotherapy
Lead sponsor: Aveiro University
Sponsor class: OTHER
First posted: 2024-10-31
Enrollment: 70
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The goal of this clinical trial is to evaluate the effectiveness of a multimodal physical exercise program for older adults (\> 60 years) with chronic musculoskeletal pain. The main question it aims to answer is:

What is the impact of the intervention program on participants´ pain intensity (primary outcome), function, physical performance, and somatosensory function (secondary outcomes)? Participants will be assessed at 3 different moments: initial assessment (T0), at the end of the intervention protocol (10 weeks) (T1) and 3 months after the end of the intervention protocol (T2). The intervention protocol will consist of a multimodal exercise program to be carried out over a period of 10 weeks at a frequency of twice a week.


Eligibility criteria: Inclusion Criteria:

* Community-dwelling older adults aged 60 years or older
* People with primary or secondary chronic musculoskeletal pain in any body site
* People able to walk independently

Exclusion Criteria:

* Individuals undergoing surgery in the last 3 months
* Patients with a self-reported diagnoses of infection diseases, dementia, tumor/cancer, stroke, uncontrolled diabetes, or at high risk of developing cardiovascular events
* Those with physical limitations that make it impossible for them to carry out the intervention protocols independently (e.g., wheelchair user)
* Patients who are receiving another physical therapy intervention to treat their pain.

Primary outcomes:
measure: Pain Severity
timeFrame: T0: baseline assessment; T1: 10 weeks (post-intervention assessment); T2: 3 months post-intervention (follow-up assessment)
Secondary outcomes:
measure: Temporal characteristics of pain
timeFrame: T0: baseline assessment; T1: 10 weeks (post-intervention assessment); T2: 3 months post-intervention (follow-up assessment)
measure: Neuropathic pain components
timeFrame: T0: baseline assessment; T1: 10 weeks (post-intervention assessment); T2: 3 months post-intervention (follow-up assessment)
measure: Pain Catastrophizing
timeFrame: T0: baseline assessment; T1: 10 weeks (post-intervention assessment); T2: 3 months post-intervention (follow-up assessment)
measure: Fear of Movement
timeFrame: T0: baseline assessment; T1: 10 weeks (post-intervention assessment); T2: 3 months post-intervention (follow-up assessment)
measure: Signs and symptoms of hypersensitivity of the nervous system
timeFrame: T0: baseline assessment; T1: 10 weeks (post-intervention assessment); T2: 3 months post-intervention (follow-up assessment)
measure: Pressure Pain Threshold measured in three different sites (thenar region of the dominant hand; dorsum of foot on dominant side; region of greatest pain)
timeFrame: T0: baseline assessment; T1: 10 weeks (post-intervention assessment); T2: 3 months post-intervention (follow-up assessment)
measure: Q-sense - Cold and Warm Perception Threshold (thenar region of the dominant hand; dorsum of foot on dominant side; region of greatest pain)
timeFrame: T0: baseline assessment; T1: 10 weeks (post-intervention assessment); T2: 3 months post-intervention (follow-up assessment)
measure: Q-sense - Heat Pain Threshold (thenar region of the dominant hand; dorsum of foot on dominant side; region of greatest pain)
timeFrame: T0: baseline assessment; T1: 10 weeks (post-intervention assessment); T2: 3 months post-intervention (follow-up assessment)
measure: Lower Limb Strength
timeFrame: T0: baseline assessment; T1: 10 weeks (post-intervention assessment); T2: 3 months post-intervention (follow-up assessment)
measure: Grip Strength
timeFrame: T0: baseline assessment; T1: 10 weeks (post-intervention assessment); T2: 3 months post-intervention (follow-up assessment)
measure: Balance
timeFrame: T0: baseline assessment; T1: 10 weeks (post-intervention assessment); T2: 3 months post-intervention (follow-up assessment)
Other outcomes:
Locations:
city: Aveiro
country: Portugal
facility: Department of Medical Sciences (University of Aveiro), Campus Universitário de Santiago, Agra do Crasto, Edifício 30
Study officials:
References: