Effectiveness Study of an Exercise Program for Older Adults With Chronic Musculoskeletal Pain

NCT06667830 | Completed

• 1 other identifier: RCT2
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Musculoskeletal Pain

Keywords

Chronic musculoskeletal pain; Older adults; Exercise program; Physiotherapy

Outcome Measures

Primary Outcomes (1)

• Pain Severity

  Brief Pain Inventory - It assesses pain intensity and functional interference related to pain in the last week. In addition to these two main aspects, it also evaluates the location of the pain, the use of medications and the amount of pain relief in the last week. The instrument has 4 items relating to pain intensity in the last week and 7 items relating to the functional interference of pain with numerical rating scales (from 0 to 10) where higher values indicate greater pain severity. In situations where the participant reports musculoskeletal pain in more than one site, they will be asked to answer the questions considering their main chronic pain.

  T0: baseline assessment; T1: 10 weeks (post-intervention assessment); T2: 3 months post-intervention (follow-up assessment)

Secondary Outcomes (11)

• Temporal characteristics of pain

  T0: baseline assessment; T1: 10 weeks (post-intervention assessment); T2: 3 months post-intervention (follow-up assessment)

• Neuropathic pain components

  T0: baseline assessment; T1: 10 weeks (post-intervention assessment); T2: 3 months post-intervention (follow-up assessment)

• Pain Catastrophizing

  T0: baseline assessment; T1: 10 weeks (post-intervention assessment); T2: 3 months post-intervention (follow-up assessment)

• Fear of Movement

  T0: baseline assessment; T1: 10 weeks (post-intervention assessment); T2: 3 months post-intervention (follow-up assessment)

• Signs and symptoms of hypersensitivity of the nervous system

  T0: baseline assessment; T1: 10 weeks (post-intervention assessment); T2: 3 months post-intervention (follow-up assessment)

Study Arms (2)

Physical exercise

ACTIVE COMPARATOR

Other: Physical exercise program

Physical exercise + Neural mobilization

EXPERIMENTAL

Other: Physical exercise program; Other: Neural mobilization techniques

Interventions

Physical exercise program OTHER

The physical exercise program will consist of exercises from three different exercise modalities: aerobic training, balance exercises, and isometric exercises.

Physical exercise; Physical exercise + Neural mobilization

Neural mobilization techniques OTHER

Neural mobilization techniques for the upper and lower quadrants will be actively performed by participants.

Physical exercise + Neural mobilization

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Aveiro University: lead

Study Sites (1)

Department of Medical Sciences (University of Aveiro), Campus Universitário de Santiago, Agra do Crasto, Edifício 30

Aveiro, 3810-193, Portugal

Location

Study Design

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

Study Record Dates

• First Submitted: October 30, 2024
• First Posted: October 31, 2024
• Study Start: October 31, 2024
• Primary Completion: February 27, 2026
• Study Completion: February 27, 2026
• Last Updated: March 2, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

PT (1)